Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RSS0343 Tablets in Healthy Subjects After Single and Multiple Oral Administration and the Effect of Food on the Pharmacokinetics of RSS0343

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

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-07

Study Completion Date

2024-11-06

Brief Summary

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To evaluate the safety and tolerability of RSS0343 tablets in healthy subjects after single and multiple oral administration

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Detailed Description

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Conditions

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Health Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment group 1: RSS0343 tablets or placebo

Group Type EXPERIMENTAL

RSS0343 tablets ；placebo

Intervention Type DRUG

RSS0343 tablets and placebo were given orally as a single dose

Treatment group 2: RSS0343 tablets or placebo

Group Type EXPERIMENTAL

RSS0343 tablets ；placebo

Intervention Type DRUG

RSS0343 tablets and placebo were given orally as a single dose

Treatment group 3: RSS0343 tablets or placebo

Group Type EXPERIMENTAL

RSS0343 tablets ；placebo

Intervention Type DRUG

RSS0343 tablets and placebo were given orally as a single dose

Treatment group 4: RSS0343 tablets or placebo

Group Type EXPERIMENTAL

RSS0343 tablets ；placebo

Intervention Type DRUG

RSS0343 tablets and placebo were given orally as a single dose

Treatment group 5: RSS0343 tablets or placebo

Group Type EXPERIMENTAL

RSS0343 tablets ；placebo

Intervention Type DRUG

RSS0343 tablets and placebo were given orally as a single dose

Treatment group 6: RSS0343 tablets or placebo

Group Type EXPERIMENTAL

RSS0343 tablets ；placebo

Intervention Type DRUG

RSS0343 tablets and placebo were taken orally multiple times

Treatment group 7: RSS0343 tablets or placebo

Group Type EXPERIMENTAL

RSS0343 tablets ；placebo

Intervention Type DRUG

RSS0343 tablets and placebo were taken orally multiple times

Treatment group 8: RSS0343 tablets or placebo

Group Type EXPERIMENTAL

RSS0343 tablets ；placebo

Intervention Type DRUG

RSS0343 tablets and placebo were taken orally multiple times

Interventions

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RSS0343 tablets ；placebo

RSS0343 tablets and placebo were given orally as a single dose

Intervention Type DRUG

RSS0343 tablets ；placebo

RSS0343 tablets and placebo were taken orally multiple times

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age of 18-55 years old (inclusive), male or female;
2. Body mass index in the range of 19-28 kg/m2 (inclusive).

Exclusion Criteria

1. The results of physical examination, vital signs, laboratory tests, chest imaging, abdominal B ultrasound and 12-lead electrocardiogram were abnormal.
2. Hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, HIV antibody positive;
3. Suspected allergy to the study drug or any component of the study drug, or severe allergy to any drug, food, toxin or other exposure;
4. Current active, latent, or inadequately treated M. tuberculosis (i.e., tuberculosis \[TB\]) infection;
5. Investigator-assessed clinically significant infection (e.g., requiring hospitalization or parenteral antimicrobial therapy) within 1 month before screening; A history of more than one previous episode of herpes zoster, or disseminated herpes zoster (one episode); Any history of other infections that the investigator considered might have been aggravated by study participation.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes