Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05638347




Registration number
NCT05638347
Ethics application status
Date submitted
27/11/2022
Date registered
6/12/2022
Date last updated
21/04/2023

Titles & IDs
Public title
A Trial of HRS-7085 Tablet in Healthy Participants With and Without Food Effect.
Scientific title
Use the Protocol Title. A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Food Effect on the Pharmacokinetics of HRS-7085 in Healthy Participants
Secondary ID [1] 0 0
HRS-7085-102-AUS
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HRS-7085 tablets
Treatment: Drugs - Placebo tablet

Experimental: HRS-7085 tablets Cohort 1 - Part 1- HRS-7085 tablets

Experimental: HRS-7085 tablets Cohort 6 - Part 1- HRS-7085 tablets


Treatment: Drugs: HRS-7085 tablets
Single oral administration

Treatment: Drugs: Placebo tablet
Single oral administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and severity of adverse events
Timepoint [1] 0 0
Start of Treatment to end of study approximately 1 week
Secondary outcome [1] 0 0
Pharmacokinetics-AUC0-last
Timepoint [1] 0 0
Start of Treatment to end of study (approximately 1 week)
Secondary outcome [2] 0 0
Pharmacokinetics-AUC0-inf
Timepoint [2] 0 0
Start of Treatment to end of study (approximately 1 week)
Secondary outcome [3] 0 0
Pharmacokinetics-Tmax
Timepoint [3] 0 0
Start of Treatment to end of study (approximately 1 week)
Secondary outcome [4] 0 0
Pharmacokinetics-Cmax
Timepoint [4] 0 0
Time Frame: Start of Treatment to end of study (approximately 1 week)
Secondary outcome [5] 0 0
Pharmacokinetics-CL/F
Timepoint [5] 0 0
Time Frame: Start of Treatment to end of study (approximately 1 week)
Secondary outcome [6] 0 0
Pharmacokinetics-Vz/F
Timepoint [6] 0 0
Time Frame: Start of Treatment to end of study (approximately 1 week)
Secondary outcome [7] 0 0
Pharmacokinetics-t1/2
Timepoint [7] 0 0
Time Frame: Start of Treatment to end of study (approximately 1 week)

Eligibility
Key inclusion criteria
1. Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial.
2. Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
3. Total body weight 45 kg~100 kg (inclusive) at screening, and body mass index (BMI) between 18 and 32 kg/m2 (inclusive).
4. For healthy subjects, no clinically significant abnormalities.
5. Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Known medical history of severe disease in cardiovascular, liver, kidney, digestive tract, mental nerve, hematology, metabolic disorders, etc.
2. Severe injuries or major surgeries within 3 months before dosing.
3. Subjects with infectious disease.
4. Live/attenuated vaccine within 3 months prior to dosing or any vaccine during the trial.
5. Blood donation or loss of = 200 mL of blood within 1 month prior to dosing, or = 400 mL of blood within 3 months prior to dosing; or receive a blood transfusion within 2 months prior to dosing.
6. Clinically significant abnormalities in 12-Lead ECG
7. More than 5 cigarettes daily (or products with equivalent amount of nicotine) for 3 months prior to screening, or positive cotinine test at screening or baseline.
8. Positive urine drug at screening or baseline.
9. Subject who cannot perform venous blood sampling.
10. Known history or suspected of being allergic to the study drugs and their excipients.
11. Use of prescription medicine within 2 weeks, or OTC medicine, within 1-week or 5 half-lives prior to dosing.
12. History of alcohol abuse within 3 months prior to screening, or positive alcohol breath test at screening or baseline.
13. Participation in clinical trials of other investigational drugs or medical devices within 1 month or 5 half-lives prior to dosing.
14. Special dietary requirements that cannot follow the meal plan in the food effect study.
15. In the investigator's judgment, may increase the risk to the subject.
16. Unwilling or unable to comply with the Lifestyle Guidelines detailed in this protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/03/2023
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Atridia Pty Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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/NCT05638347