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

Inflammatory Bowel Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05638347
• Other study ID #: HRS-7085-102-AUS
• Status: Completed
• Phase: Phase 1
• Start date: December 5, 2022
• Est. completion date: March 16, 2023

Study information

• Verified date: April 2023
• Source: Atridia Pty Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 16, 2023
• Est. primary completion date: March 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases

Intervention

Drug:
• HRS-7085 tablets
Single oral administration
• Placebo tablet
Single oral administration

Locations

Country	Name	City	State
Australia	Linear Clinical Research	Nedlands	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
Atridia Pty Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events		Start of Treatment to end of study approximately 1 week
Secondary	Pharmacokinetics-AUC0-last	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)
Secondary	Pharmacokinetics-AUC0-inf	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)
Secondary	Pharmacokinetics-Tmax	Time to Cmax of HRS-7085	Start of Treatment to end of study (approximately 1 week)
Secondary	Pharmacokinetics-Cmax	Maximum observed concentration of HRS-7085	Time Frame: Start of Treatment to end of study (approximately 1 week)
Secondary	Pharmacokinetics-CL/F	Apparent clearance of HRS-7085	Time Frame: Start of Treatment to end of study (approximately 1 week)
Secondary	Pharmacokinetics-Vz/F	Apparent volume of distribution during terminal phase of HRS-7085	Time Frame: Start of Treatment to end of study (approximately 1 week)
Secondary	Pharmacokinetics-t1/2	Terminal elimination half-life of HRS-7085	Time Frame: Start of Treatment to end of study (approximately 1 week)