- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05638347
A Trial of HRS-7085 Tablet in Healthy Participants With and Without Food Effect.
April 19, 2023 updated by: Atridia Pty Ltd.
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
The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of HRS-7085.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kathy You
- Phone Number: +61 02 9299 0433
- Email: kathyyou@atridia.com
Study Contact Backup
- Name: Sandro Miranda
- Phone Number: +61 435 609 997
- Email: sandro.miranda@atridia.com
Study Locations
-
-
Western Australia
-
Nedlands, Western Australia, Australia, 6009
- Linear Clinical Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial.
- Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
- Total body weight 45 kg~100 kg (inclusive) at screening, and body mass index (BMI) between 18 and 32 kg/m2 (inclusive).
- For healthy subjects, no clinically significant abnormalities.
- Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods
Exclusion Criteria:
- Known medical history of severe disease in cardiovascular, liver, kidney, digestive tract, mental nerve, hematology, metabolic disorders, etc.
- Severe injuries or major surgeries within 3 months before dosing.
- Subjects with infectious disease.
- Live/attenuated vaccine within 3 months prior to dosing or any vaccine during the trial.
- 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.
- Clinically significant abnormalities in 12-Lead ECG
- 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.
- Positive urine drug at screening or baseline.
- Subject who cannot perform venous blood sampling.
- Known history or suspected of being allergic to the study drugs and their excipients.
- Use of prescription medicine within 2 weeks, or OTC medicine, within 1-week or 5 half-lives prior to dosing.
- History of alcohol abuse within 3 months prior to screening, or positive alcohol breath test at screening or baseline.
- Participation in clinical trials of other investigational drugs or medical devices within 1 month or 5 half-lives prior to dosing.
- Special dietary requirements that cannot follow the meal plan in the food effect study.
- In the investigator's judgment, may increase the risk to the subject.
- Unwilling or unable to comply with the Lifestyle Guidelines detailed in this protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HRS-7085 tablets Cohort 1
Part 1- HRS-7085 tablets
|
Single oral administration
Single oral administration
|
Experimental: HRS-7085 tablets Cohort 6
Part 1- HRS-7085 tablets
|
Single oral administration
Single oral administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence and severity of adverse events
Time Frame: Start of Treatment to end of study approximately 1 week
|
Start of Treatment to end of study approximately 1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics-AUC0-last
Time Frame: Start of Treatment to end of study (approximately 1 week)
|
Area under the concentration-time curve from time 0 to last time point after HRS-7085 administration
|
Start of Treatment to end of study (approximately 1 week)
|
Pharmacokinetics-AUC0-inf
Time Frame: Start of Treatment to end of study (approximately 1 week)
|
Area under the concentration-time curve from time 0 to infinity after HRS-7085 administration
|
Start of Treatment to end of study (approximately 1 week)
|
Pharmacokinetics-Tmax
Time Frame: Start of Treatment to end of study (approximately 1 week)
|
Time to Cmax of HRS-7085
|
Start of Treatment to end of study (approximately 1 week)
|
Pharmacokinetics-Cmax
Time Frame: Time Frame: Start of Treatment to end of study (approximately 1 week)
|
Maximum observed concentration of HRS-7085
|
Time Frame: Start of Treatment to end of study (approximately 1 week)
|
Pharmacokinetics-CL/F
Time Frame: Time Frame: Start of Treatment to end of study (approximately 1 week)
|
Apparent clearance of HRS-7085
|
Time Frame: Start of Treatment to end of study (approximately 1 week)
|
Pharmacokinetics-Vz/F
Time Frame: Time Frame: Start of Treatment to end of study (approximately 1 week)
|
Apparent volume of distribution during terminal phase of HRS-7085
|
Time Frame: Start of Treatment to end of study (approximately 1 week)
|
Pharmacokinetics-t1/2
Time Frame: Time Frame: Start of Treatment to end of study (approximately 1 week)
|
Terminal elimination half-life of HRS-7085
|
Time Frame: Start of Treatment to end of study (approximately 1 week)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 5, 2022
Primary Completion (Actual)
March 16, 2023
Study Completion (Actual)
March 16, 2023
Study Registration Dates
First Submitted
November 27, 2022
First Submitted That Met QC Criteria
November 27, 2022
First Posted (Actual)
December 6, 2022
Study Record Updates
Last Update Posted (Actual)
April 21, 2023
Last Update Submitted That Met QC Criteria
April 19, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HRS-7085-102-AUS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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