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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-05

Study Completion Date

2023-03-16

Brief Summary

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

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Detailed Description

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Conditions

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Inflammatory Bowel Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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HRS-7085 tablets Cohort 1

Part 1- HRS-7085 tablets

Group Type EXPERIMENTAL

HRS-7085 tablets

Intervention Type DRUG

Single oral administration

Placebo tablet

Intervention Type DRUG

Single oral administration

HRS-7085 tablets Cohort 6

Part 1- HRS-7085 tablets

Group Type EXPERIMENTAL

HRS-7085 tablets

Intervention Type DRUG

Single oral administration

Placebo tablet

Intervention Type DRUG

Single oral administration

Interventions

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HRS-7085 tablets

Single oral administration

Intervention Type DRUG

Placebo tablet

Single oral administration

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes