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

NCT07101965 | Completed Phase 1

• 1 other identifier: RSD51318
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Health Volunteer

Outcome Measures

Primary Outcomes (1)

• adverse events

  The observation lasted until the 61th day

Secondary Outcomes (11)

• Cmax

  The observation lasted until the 33th day

• AUC0-t

  The observation lasted until the 33th day

• AUC0-inf

  The observation lasted until the 33th day

• Tmax

  The observation lasted until the 33th day

• t1/2

  The observation lasted until the 33th day

Study Arms (8)

Treatment group 1: RSS0343 tablets or placebo

EXPERIMENTAL

Drug: RSS0343 tablets ；placebo

Treatment group 2: RSS0343 tablets or placebo

EXPERIMENTAL

Drug: RSS0343 tablets ；placebo

Treatment group 3: RSS0343 tablets or placebo

EXPERIMENTAL

Drug: RSS0343 tablets ；placebo

Treatment group 4: RSS0343 tablets or placebo

EXPERIMENTAL

Drug: RSS0343 tablets ；placebo

Treatment group 5: RSS0343 tablets or placebo

EXPERIMENTAL

Drug: RSS0343 tablets ；placebo

Treatment group 6: RSS0343 tablets or placebo

EXPERIMENTAL

Drug: RSS0343 tablets ；placebo

Treatment group 7: RSS0343 tablets or placebo

EXPERIMENTAL

Drug: RSS0343 tablets ；placebo

Treatment group 8: RSS0343 tablets or placebo

EXPERIMENTAL

Drug: RSS0343 tablets ；placebo

Interventions

RSS0343 tablets ；placebo DRUG

RSS0343 tablets and placebo were given orally as a single dose

Treatment group 1: RSS0343 tablets or placebo; Treatment group 2: RSS0343 tablets or placebo; Treatment group 3: RSS0343 tablets or placebo; Treatment group 4: RSS0343 tablets or placebo; Treatment group 5: RSS0343 tablets or placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• The results of physical examination, vital signs, laboratory tests, chest imaging, abdominal B ultrasound and 12-lead electrocardiogram were abnormal.
• Hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, HIV antibody positive;
• Suspected allergy to the study drug or any component of the study drug, or severe allergy to any drug, food, toxin or other exposure;
• Current active, latent, or inadequately treated M. tuberculosis (i.e., tuberculosis \[TB\]) infection;
• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)

Shandong, Jinan, 250013, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: August 3, 2025
• Study Start: April 7, 2024
• Primary Completion: November 6, 2024
• Study Completion: November 6, 2024
• Last Updated: August 3, 2025

Record last verified: 2025-07

Locations

CN (1)