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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06183671
Registration number
NCT06183671
Ethics application status
Date submitted
20/11/2023
Date registered
27/12/2023
Date last updated
26/02/2024
Titles & IDs
Public title
JX09 SAD/MAD in Healthy Participants
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Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multi-Part, Single and Multiple Ascending Dose Study of JX09 in Healthy Adult Participants
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Secondary ID [1]
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JX09002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Resistant Hypertension
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Condition category
Condition code
Cardiovascular
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - JX09 or placebo SAD
Treatment: Drugs - JX09 or placebo MAD
Treatment: Drugs - JX09
Experimental: Ascending Single Doses - 48 participants, 6 single ascending dose (SAD) cohorts (Cohorts 1 to 6). Within each cohort, 8 participants will be randomized in a 6:2 ratio, 6 participants receiving JX09 and 2 receiving placebo
Experimental: Ascending Multiple Doses - 32 participants, 4 multiple ascending dose (MAD) cohorts (Cohorts 7 to 10). Within each cohort, 8 participants will be randomized in a 6:2 ratio, 6 participants receiving JX09 and 2 receiving placebo
Experimental: Food Effect - 12 participants,1 single-dose food effect (FE) cohort (Cohort 11), open-label, two-sequence, two-period, crossover design, participants will be randomly assigned to 1 of the 2 crossover sequences
Treatment: Drugs: JX09 or placebo SAD
For Part 1 SAD: JX09/placebo in capsule will be administered as a single oral dose. The nominal dose escalation scheme for the cohorts is 1, 3, 10, 30, 100, and 300 mg.
Treatment: Drugs: JX09 or placebo MAD
For Part 2 MAD: JX09/placebo in capsule will be administered for 11 days (once daily) The nominal dose escalation scheme for the cohorts is 2, 5, 10 and 20 mg.
Treatment: Drugs: JX09
For Part 3 FE: JX09 in capsule will be administered as a two single oral doses separated by 15 days. The nominal dose is 10 mg.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The incidence of adverse events and serious adverse events in health subjects.
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Assessment method [1]
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The number of AEs and SAEs by using Common Terminology Criteria for Adverse Events (CTCAE) V5.0
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Timepoint [1]
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For SAD cohort,11 days, from Day 1 to Day 11; for MAD cohort,21 days, from Day 1 to Day 21; for food effect cohort,26 days, from Day 1 to Day 26
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Primary outcome [2]
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Clinically significant change from baseline in physical examinations in health subjects
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Assessment method [2]
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The number of events that clinically significant change from baseline in physical examinations by measuring general appearance, head, ears, eyes, nose, throat, dentition, thyroid, chest, abdomen, skin, neurological extremities, etc.
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Timepoint [2]
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For SAD cohort,11 days, from Day 1 to Day 11; for MAD cohort,21 days, from Day 1 to Day 21; for food effect cohort,26 days, from Day 1 to Day 26
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Primary outcome [3]
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Clinically significant change from baseline in vital signs in health subjects
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Assessment method [3]
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The number of events that clinically significant change from baseline in vital signs by measuring heart rate, blood pressure, temperature, and respiratory rate.
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Timepoint [3]
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For SAD cohort,11 days, from Day 1 to Day 11; for MAD cohort,21 days, from Day 1 to Day 21; for food effect cohort,26 days, from Day 1 to Day 26
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Primary outcome [4]
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Clinically significant change from baseline in electrocardiograms in health subjects
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Assessment method [4]
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The number of events that clinically significant change from baseline in electrocardiograms by measuring heart rate, PR, QRS, QT and QTc interval.
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Timepoint [4]
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For SAD cohort,11 days, from Day 1 to Day 11; for MAD cohort,21 days, from Day 1 to Day 21; for food effect cohort,26 days, from Day 1 to Day 26
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Primary outcome [5]
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Clinically significant change from baseline in clinical laboratory tests in health subjects
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Assessment method [5]
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The number of events that clinically significant change from baseline in clinical laboratory tests by measuring clinical chemistry panel, complete blood count and coagulation.
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Timepoint [5]
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For SAD cohort,11 days, from Day 1 to Day 11; for MAD cohort,21 days, from Day 1 to Day 21; for food effect cohort,26 days, from Day 1 to Day 26
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Secondary outcome [1]
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Plasma pharmacokinetic parameters after a single ascending dose in health subjects
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Assessment method [1]
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Area under the Concentration time Curve from Time 0 to the Last Measurable Concentration (AUC0-t) by measuring blood plasma
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Timepoint [1]
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From Day 1 to Day 11
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Secondary outcome [2]
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Plasma pharmacokinetic parameters after a single ascending dose in health subjects
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Assessment method [2]
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Area under the Concentration-time Curve from Time 0 to 24 hour (AUC0-24) by measuring blood plasma
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Timepoint [2]
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From Day 1 to Day 11
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Secondary outcome [3]
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Plasma pharmacokinetic parameters after a single ascending dose in health subjects
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Assessment method [3]
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Area under the Concentration-time Curve from Time 0 to Infinity (AUC0-inf) by measuring blood plasma
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Timepoint [3]
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From Day 1 to Day 11
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Secondary outcome [4]
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Plasma pharmacokinetic parameters after a single ascending dose in health subjects
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Assessment method [4]
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Peak plasma concentration (CMAX) by measuring blood plasma
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Timepoint [4]
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From Day 1 to Day 11
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Secondary outcome [5]
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Plasma pharmacokinetic parameters after a single ascending dose in health subjects
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Assessment method [5]
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Time of maximum concentration (TMAX) by measuring blood plasma
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Timepoint [5]
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From Day 1 to Day 11
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Secondary outcome [6]
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Plasma pharmacokinetic parameters after multiple ascending dose in health subjects
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Assessment method [6]
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Peak plasma concentration (CMAX) by measuring blood plasma
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Timepoint [6]
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On day 1 and day 11
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Secondary outcome [7]
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Plasma pharmacokinetic parameters after multiple ascending dose in health subjects
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Assessment method [7]
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Time of maximum concentration (TMAX) by measuring blood plasma
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Timepoint [7]
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On day 1 and day 11
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Secondary outcome [8]
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Plasma pharmacokinetic parameters after multiple ascending dose in health subjects
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Assessment method [8]
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Area under the Concentration time Curve from Time 0 to the Last Measurable Concentration (AUC0-t) by measuring blood plasma
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Timepoint [8]
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On day 1 and day 11
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Secondary outcome [9]
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Plasma pharmacokinetic parameters after multiple ascending dose in health subjects
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Assessment method [9]
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Area under the Concentration-time Curve from Time 0 to 24 hour (AUC0-24) by measuring blood plasma
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Timepoint [9]
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On day 1 and day 11
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Secondary outcome [10]
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Plasma pharmacokinetic parameters after multiple ascending dose in health subjects
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Assessment method [10]
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Concentration at end of dosing interval by measuring blood plasma
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Timepoint [10]
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From day 2 to day 11
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Secondary outcome [11]
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Plasma pharmacokinetic parameters in health subjects under fed and fasted conditions
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Assessment method [11]
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Area under the Concentration time Curve from Time 0 to the Last Measurable Concentration (AUC0-t) by measuring blood plasma
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Timepoint [11]
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From day 1 to day 5 and on day 11, From day 16 to day 20 and day 26
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Secondary outcome [12]
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Plasma pharmacokinetic parameters in health subjects under fed and fasted conditions
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Assessment method [12]
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Area under the Concentration-time Curve from Time 0 to 24 hour (AUC0-24) by measuring blood plasma
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Timepoint [12]
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From day 1 to day 5 and on day 11, From day 16 to day 20 and day 26
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Secondary outcome [13]
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Plasma pharmacokinetic parameters in health subjects under fed and fasted conditions
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Assessment method [13]
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Area under the Concentration-time Curve from Time 0 to Infinity (AUC0-inf) by measuring blood plasma
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Timepoint [13]
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From day 1 to day 5 and on day 11, From day 16 to day 20 and day 26
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Secondary outcome [14]
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Urine pharmacokinetic parameters after multiple ascending dose in health subjects
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Assessment method [14]
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Cumulative amount of drug excreted by measuring urine
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Timepoint [14]
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on day 1 and day 11
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Secondary outcome [15]
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Urine pharmacokinetic parameters after multiple ascending dose in health subjects
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Assessment method [15]
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Fraction of the dose excreted renally by measuring urine
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Timepoint [15]
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on day 1 and day 11
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Secondary outcome [16]
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Urine pharmacokinetic parameters after multiple ascending dose in health subjects
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Assessment method [16]
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Renal clearance by measuring urine
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Timepoint [16]
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on day 1 and day 11
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Secondary outcome [17]
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Plasma pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
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Assessment method [17]
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Change from baseline of aldosterone by measuring blood plasma
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Timepoint [17]
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From Day -1 to Day 5 and Day 11 for SAD cohort and from Day -2 to Day 1 and from Day 7 to Day 15 and Day 21 for MAD cohort
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Secondary outcome [18]
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Plasma pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
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Assessment method [18]
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Change from baseline of cortisol by measuring blood plasma
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Timepoint [18]
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From Day -1 to Day 5 and Day 11 for SAD cohort and from Day -2 to Day 1 and from Day 7 to Day 15 and Day 21 for MAD cohort
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Secondary outcome [19]
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Plasma pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
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Assessment method [19]
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Change from baseline of corticosterone by measuring blood plasma
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Timepoint [19]
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From Day -1 to Day 5 and Day 11 for SAD cohort and from Day -2 to Day 1 and from Day 7 to Day 15 and Day 21 for MAD cohort
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Secondary outcome [20]
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Urine pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
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Assessment method [20]
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Change from baseline of sodium by measuring 24-hour urine level
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Timepoint [20]
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On Day 1 for SAD cohort and on Day -1 and 11 for MAD cohort
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Secondary outcome [21]
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Urine pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
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Assessment method [21]
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Change from baseline of potassium by measuring 24-hour urine level
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Timepoint [21]
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On Day 1 for SAD cohort and on Day -1 and 11 for MAD cohort
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Secondary outcome [22]
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Urine pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
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Assessment method [22]
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Change from baseline of aldosterone by measuring 24-hour urine level
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Timepoint [22]
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On Day 1 for SAD cohort and on Day -1 and 11 for MAD cohort
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Secondary outcome [23]
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Urine pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
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Assessment method [23]
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Change from baseline of cortisol by measuring 24-hour urine level
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Timepoint [23]
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On Day 1 for SAD cohort and on Day -1 and 11 for MAD cohort
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Eligibility
Key inclusion criteria
* Male or female aged 18 to 55 years (inclusive)
* In good health as deemed by the Investigator through a medical evaluation, including medical history, physical examination, and laboratory tests
* Body mass index (BMI) between 18 and 32 kg/m2, with a minimum weight of 50 kg at Screening
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Clinically significant oncologic, infectious, cardiovascular, pulmonary, hepatic, gastrointestinal, hematologic, metabolic, endocrine, neurologic, immunologic, renal, psychiatric, or other condition that in the opinion of the Investigator or Medical Monitor would make is unsafe for the participant to join the study or fulfill its requirements.
* A clinical abnormality or abnormal laboratory parameter(s) in the opinion of the Investigator or Medical Monitor is likely to introduce additional risk or will affect data interpretation.
* Postural tachycardia or hypotension.
* Female of childbearing potential who is pregnant, lactating, or planning to become pregnant.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/01/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2024
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Actual
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Sample size
Target
92
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Nucleus Network Pty Ltd - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Ji Xing Pharmaceuticals Australia Pty Ltd
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Novotech (Australia) Pty Limited
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a phase 1, randomized, double-blind, placebo-controlled, multi-part, single and multiple ascending dose study in healthy adult to test the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of JX09 when administered to healthy adult subjects.
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Trial website
https://clinicaltrials.gov/study/NCT06183671
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Sam Francis, MD
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Address
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Nucleus Network Pty Ltd.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Cherry Dong
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Address
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Country
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Phone
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86-21-8031 1808
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06183671
Download to PDF