A Trial of HRS-7085 Tablet in Healthy Participants With and Without Food Effect.

Phase 1

Completed

• Conditions: Inflammatory Bowel Disease
• Interventions: Drug: HRS-7085 tablets; Drug: Placebo tablet

• Registration Number: NCT05638347
• Lead Sponsor: Atridia Pty Ltd.

Brief Summary

The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of HRS-7085.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-27
• Study First Submitted QC: 2022-11-27
• Study Start: 2022-12-05
• Study First Posted: 2022-12-06
• Primary Completion: 2023-03-16
• Study Completion: 2023-03-16
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-19
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
HRS-7085 tablets Cohort 1	HRS-7085 tablets	Part 1- HRS-7085 tablets
HRS-7085 tablets Cohort 1	Placebo tablet	Part 1- HRS-7085 tablets
HRS-7085 tablets Cohort 6	HRS-7085 tablets	Part 1- HRS-7085 tablets
HRS-7085 tablets Cohort 6	Placebo tablet	Part 1- HRS-7085 tablets

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events	Start of Treatment to end of study approximately 1 week

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics-AUC0-last	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
Pharmacokinetics-AUC0-inf	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
Pharmacokinetics-CL/F	Time Frame: Start of Treatment to end of study (approximately 1 week)	Apparent clearance of HRS-7085
Pharmacokinetics-t1/2	Time Frame: Start of Treatment to end of study (approximately 1 week)	Terminal elimination half-life of HRS-7085
Pharmacokinetics-Tmax	Start of Treatment to end of study (approximately 1 week)	Time to Cmax of HRS-7085
Pharmacokinetics-Vz/F	Time Frame: Start of Treatment to end of study (approximately 1 week)	Apparent volume of distribution during terminal phase of HRS-7085
Pharmacokinetics-Cmax	Time Frame: Start of Treatment to end of study (approximately 1 week)	Maximum observed concentration of HRS-7085

Trial Locations

Locations (1)

Linear Clinical Research; 🇦🇺 Nedlands, Western Australia, Australia