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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06012578
Registration number
NCT06012578
Ethics application status
Date submitted
17/08/2023
Date registered
25/08/2023
Date last updated
13/11/2023
Titles & IDs
Public title
Study Evaluating ISM5411 Administered Orally to Healthy Volunteers
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Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Ascending Dose and Food Effect Study to Evaluate Safety, Tolerability, Pharmacokinetics and Food Effect of ISM5411 in Healthy Subjects
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Secondary ID [1]
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ISM5411-101
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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:
Healthy Subjects
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ISM5411
Treatment: Drugs - Placebo
Experimental: ISM5411 -
Placebo Comparator: Placebo -
Treatment: Drugs: ISM5411
Investigational Drug
Treatment: Drugs: Placebo
ISM5411 Matching Placebo
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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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Number of participants with Adverse Events (AEs) after single or multiple doses of ISM5411.
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Assessment method [1]
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The number of participants with treatment related AEs as assessed by CTCAE v5.0. will be monitored.
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Timepoint [1]
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Up to 7 days after last dose.
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Primary outcome [2]
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Number of participants with clinically significant changes in vital signs
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Assessment method [2]
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The number of participants with clinically significant changes in vital signs will be monitored based on the assessment of blood pressure, heart rate, respiration and body temperature before and after administration.
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Timepoint [2]
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Up to 7 days after last dose.
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Primary outcome [3]
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Number of participants with clinically significant changes in in chemistry laboratory values
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Assessment method [3]
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The number of participants with clinically significant changes in blood routine, blood biochemistry, urine routine, coagulation function, etc. will be monitored before and after administration.
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Timepoint [3]
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Up to 7 days after last dose
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Primary outcome [4]
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Number of participants with clinically significant changes in 12-lead Electrocardiogram (ECG) readings
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Assessment method [4]
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The number of participants with clinically significant changes in 12-lead Electrocardiogram (ECG) readings will be monitored based on changes in cardiovascular system function (change in QTC parameters) as a criterion of safety and tolerability variables.
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Timepoint [4]
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Up to 7 days after last dose
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Primary outcome [5]
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Number of participants with clinically significant changes in physical examinations
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Assessment method [5]
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Complete physical examination should include the head and face, skin system, lymph nodes, eyes, ears, nose and throat, mouth, respiratory system, cardiovascular system, abdomen, musculoskeletal system, nervous system and mental status.
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Timepoint [5]
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Up to 7 days after last dose
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Secondary outcome [1]
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Maximum plasma concentration (Cmax) of ISM5411
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Assessment method [1]
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To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
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Timepoint [1]
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Day 1 through Day 17
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Secondary outcome [2]
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Time at which the maximum plasma concentration occurred (tmax) of ISM5411
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Assessment method [2]
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To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
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Timepoint [2]
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Day 1 through Day 17
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Secondary outcome [3]
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Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of ISM5411
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Assessment method [3]
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To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
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Timepoint [3]
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Day 1 through Day 17
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Secondary outcome [4]
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Area under the plasma concentration-time curve from time zero to time with last measurable concentration t (AUC0-t) of ISM5411
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Assessment method [4]
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To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
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Timepoint [4]
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Day 1 through Day 17
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Secondary outcome [5]
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Elimination rate constant (?z) of ISM5411
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Assessment method [5]
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To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
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Timepoint [5]
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Day 1 through Day 17
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Secondary outcome [6]
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Elimination half-life (t1/2) of ISM5411
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Assessment method [6]
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To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
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Timepoint [6]
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Day 1 through Day 17
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Secondary outcome [7]
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Apparent volume of distribution (Vz/F) of ISM5411
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Assessment method [7]
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To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
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Timepoint [7]
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Day 1 through Day 17
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Secondary outcome [8]
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Apparent total plasma clearance (CL/F) of ISM5411
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Assessment method [8]
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To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
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Timepoint [8]
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Day 1 through Day 17
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Secondary outcome [9]
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Mean residence time (MRT) of ISM5411
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Assessment method [9]
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To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
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Timepoint [9]
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Day 1 through Day 17
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Secondary outcome [10]
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Renal clearance rate (CLR) of ISM5411
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Assessment method [10]
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To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
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Timepoint [10]
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Day 1 through Day 17
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Secondary outcome [11]
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Accumulative excretion (Ae) of ISM5411
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Assessment method [11]
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To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
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Timepoint [11]
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Day 1 through Day 17
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Secondary outcome [12]
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Fractional excretion (fe) of ISM5411
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Assessment method [12]
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To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
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Timepoint [12]
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Day 1 through Day 17
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Secondary outcome [13]
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Relative bioavailability (fed/fasted) of ISM5411
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Assessment method [13]
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To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
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Timepoint [13]
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Day 1 through Day 17
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Eligibility
Key inclusion criteria
1. Subjects who have signed the informed consent form (ICF) prior to the study, fully
understand the content, procedures and possible adverse reactions of the study, and
are able to complete the study in accordance with the protocol requirements.
2. Subjects (including their partners) who have no plan to become pregnant and
voluntarily use effective contraception as described in section 8.1 from screening to
3 months after the last dose.
3. Male and female subjects aged 18-55 years (inclusive).
4. Body weight =50 kg for males and =45 kg for females, with a body mass index (BMI =
weight (kg)/height2 (m2)) of 18 ~ 32 kg/m2 (inclusive).
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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
1. Allergy to the IP or any of its ingredients, or allergic constitution (allergy to more
than 1 drugs and food).
2. History of dysphagia or any gastrointestinal surgery (appendicectomy and
cholecystectomy are excluded) or disease that affects drug absorption and/or
elimination.
3. Presence of clinically relevant diseases evidenced by clinical findings, which are
making implementation of the protocol or interpretation of the study results
difficult, or that would put the subject at risk by participating in the study in the
opinion of the investigator, including but not limited to gastrointestinal, renal,
hepatic, neurological, hematological, endocrine, oncological, pulmonary,
immunological, psychiatric or cardiovascular and cerebrovascular diseases).
4. Presence of abnormal and clinically significant medical history, physical examination,
vital signs, 12-lead ECG, clinical laboratory tests, abdominal color Doppler
ultrasound, or other investigations at screening (Repeat testing will be allowed by
the investigator discretion).
5. Positive human immunodeficiency virus antibody (HIV-Ab), hepatitis B surface antigen
(HBsAg) and hepatitis C antibody (HCV-Ab) in the viral serology testing at screening.
6. Smoking > 5 cigarettes or an equivalent amount of tobacco per day, or consuming = 14
units of alcohol per week (1 unit of alcohol ˜ 25 mL of spirits/100 mL of wine/285 mL
of beer) within 1 months prior to screening or unwilling to abstain from smoking or
drinking during the study.
7. Subjects who are positive for urine drug testing at screening or Day-1, or have a
history of drug abuse or narcotic use in the past five years (Repeat testing will be
allowed by the investigator discretion).
8. Subjects who have donated blood or lost a significant amount of blood (>400 mL) within
1 months prior to screening, or who plan to donate blood during the study or within 1
month after the end of the study.
9. Subjects who have undergone major surgical procedures (major visceral, organ, or bone
surgeries) that may affect the study in the judgment of the investigator within 3
months prior to screening, or who intend to have such procedures during the study.
10. Intolerance to vein puncture, or presence of a history of blood phobia or
trypanophobia.
11. Use of any prescription drugs within 14 days prior to the admission. Use of counter
medication / vitamins / supplements within 7 days prior to admission (with the
exception of contraception, occasional paracetamol, and standard dose of
multivitamins).
12. Subjects who have receipt of any study drug or participated in any medical device
clinical studies within 1 month (or 5 half-lives, whichever is longer) prior to
screening.
13. Vaccination with any live or attenuated vaccine within 1 month prior to screening.
14. Any acute disease or acute attack of any chronic disease within 28 days prior to
screening.
15. Consumption of any caffeinated food or beverages (such as coffee, strong tea, cola,
chocolate, etc.), xanthine-rich food (such as anchovies, sardines, bovine liver,
bovine kidney, etc.), food that induces or inhibits liver metabolizing enzymes (such
as dragon fruits, mango, grapefruit, pomegranate, etc.) and beverages made thereof, or
food or beverages containing alcohol, or presence of other factors that may affect the
absorption, distribution, metabolism or excretion of the drug (such as strenuous
exercise) within 48 hours prior to IP.
16. Female subjects who are in lactation or positive for serum pregnancy test during the
screening period or study course.
17. Subjects who, in the judgment of the investigator, are not suitable for participation
in the study.
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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 analysing the results/data
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Intervention assignment
Other
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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
8/11/2023
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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
1/09/2024
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Actual
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Sample size
Target
76
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Nucleus Network - 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
InSilico Medicine Hong Kong Limited
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The goal of this clinical trial is to learn about ISM5411 in healthy subjects. The primary
objective is to evaluate the safety and tolerability of single and multiple oral doses of
ISM5411 in healthy subjects.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06012578
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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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Address
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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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Yichen Liu
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Address
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Country
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Phone
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+86 18817554306
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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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06012578
Download to PDF