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

Sponsor

Atridia Pty Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05638347

Collaborator

(none)

Enrollment

Location

Arms

3.7

Anticipated Duration (Months)

11.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Disease	Drug: HRS-7085 tablets Drug: Placebo tablet	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Part 1: HRS-7085 Single Ascending Dose (SAD) Both males and females are planned to be enrolled in five cohorts (optional and determined by Safety Review Committee (SRC) in this SAD study Part 2: Food Effect: Participants in cohort 3 who have finished the follow-up visit will be involved in the food effect study after safety evaluation by the investigator.Part 1: HRS-7085 Single Ascending Dose (SAD) Both males and females are planned to be enrolled in five cohorts (optional and determined by Safety Review Committee (SRC) in this SAD study Part 2: Food Effect: Participants in cohort 3 who have finished the follow-up visit will be involved in the food effect study after safety evaluation by the investigator.

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 5, 2022

Anticipated Primary Completion Date :

Feb 27, 2023

Anticipated Study Completion Date :

Mar 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HRS-7085 tablets Cohort 1 Part 1- HRS-7085 tablets Single Ascending Dose	Drug: HRS-7085 tablets Single oral administration Drug: Placebo tablet Single oral administration
Experimental: HRS-7085 tablets Cohort 2 Part 1- HRS-7085 tablets Single Ascending Dose	Drug: HRS-7085 tablets Single oral administration Drug: Placebo tablet Single oral administration
Experimental: HRS-7085 tablets Cohort 3 Part 1- HRS-7085 tablets Single Ascending Dose	Drug: HRS-7085 tablets Single oral administration Drug: Placebo tablet Single oral administration
Experimental: HRS-7085 tablets Cohort 4 Part 1- HRS-7085 tablets Single Ascending Dose	Drug: HRS-7085 tablets Single oral administration Drug: Placebo tablet Single oral administration
Experimental: HRS-7085 tablets Cohort 5 Part 1- HRS-7085 tablets Single Ascending Dose	Drug: HRS-7085 tablets Single oral administration Drug: Placebo tablet Single oral administration
Experimental: HRS-7085 tablets Cohort 3 (Food Effect) Part 2- HRS-7085 tablets with food effect	Drug: HRS-7085 tablets Single oral administration Drug: Placebo tablet Single oral administration

Outcome Measures

Primary Outcome Measures

Incidence and severity of adverse events [Start of Treatment to end of study approximately 1 week]

Secondary Outcome Measures

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-Tmax [Start of Treatment to end of study (approximately 1 week)]
Time to Cmax of HRS-7085
Pharmacokinetics-Cmax [Time Frame: Start of Treatment to end of study (approximately 1 week)]
Maximum observed concentration of HRS-7085
Pharmacokinetics-CL/F [Time Frame: Start of Treatment to end of study (approximately 1 week)]
Apparent clearance 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-t1/2 [Time Frame: Start of Treatment to end of study (approximately 1 week)]
Terminal elimination half-life of HRS-7085

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Linear Clinical Research	Nedlands	Western Australia	Australia	6009

Sponsors and Collaborators

Atridia Pty Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Atridia Pty Ltd.

ClinicalTrials.gov Identifier:

NCT05638347

Other Study ID Numbers:

HRS-7085-102-AUS

First Posted:

Dec 6, 2022

Last Update Posted:

Dec 21, 2022

Last Verified:

Nov 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Inflammatory Bowel Diseases

Study Results

No Results Posted as of Dec 21, 2022