A Clinical Study of RSS0343 in Healthy Subjects

NCT07289464 | Recruiting Phase 1

• 1 other identifier: RSS0343-102
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I study to evaluate the safety, tolerability and pharmacokinetics of RSS0343 following multiple oral doses in healthy subjects, as well as its effects on the QT/QTc interval.

Conditions

Non-cystic Fibrosis Bronchiectasis

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of any adverse events (AEs).

  Safety and tolerability.

  Evaluation was performed up to Day 28.

Secondary Outcomes (14)

• Maximum observed plasma concentration of RSS0343 at Day 1 (Cmax).

  Evaluation was performed up to Day 28.

• Maximum observed plasma concentration of RSS0343 at steady state (Cmax,ss).

  Evaluation was performed up to Day 28.

• Time to Cmax (Tmax).

  Evaluation was performed up to Day 28.

• Time to Cmax,ss (Tmax,ss).

  Evaluation was performed up to Day 28.

• Area under the concentration-time curve during a dosing interval (AUC0-tau).

  Evaluation was performed up to Day 28.

Study Arms (2)

RSS0343 Tablets Group

EXPERIMENTAL

Drug: RSS0343 Tablets

RSS0343 Tablets Placebo Group

PLACEBO COMPARATOR

Drug: RSS0343 Tablets Placebo

Interventions

RSS0343 Tablets DRUG

RSS0343 tablets, oral.

RSS0343 Tablets Group

RSS0343 Tablets Placebo DRUG

RSS0343 tablets placebo, oral.

RSS0343 Tablets Placebo Group

Eligibility Criteria

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

You may qualify if:

• Subjects who provided written informed consent after being fully informed of the trial's purpose, significance, and protocol requirements.
• Healthy individuals aged 18 to 55 years, inclusive. Males and females
• Body weight ≥ 50 kg for males and ≥ 45 kg for females. Body mass index (BMI) = weight (kg)/height 2 (m²). BMI between 19 and 28 kg/m², inclusive.
• Fertile male and female subjects and their partners must agree to use highly effective contraception as stipulated in the protocol, from screening until 6 months (for females) or 3 months (for males) after the last dose. Additionally, fertile female subjects must have a negative serum pregnancy test at screening and prior to the first dose (baseline) and must not be lactating.

You may not qualify if:

• Subjects who smoked more than 5 cigarettes (or equivalent nicotine products) daily within 3 months prior to screening or intended to use tobacco products during the trial.
• Subjects with frequent alcohol consumption (\>15 g/day for females or \>25 g/day for males \[5g of alcohol is equivalent to 150 mL of beer, 50 mL of wine or approximately 17 mL of low-alcohol liquor\], on more than 2 occasions per week) within 6 months prior to screening, or were unable to abstain during the trial, or who tested positive on the alcohol breath test at baseline.
• Subjects with a history of, or current, drug abuse, or drug dependence (during consultation), or with a positive urine drug screening result.
• Subjects who had donated blood or experienced a total blood loss of ≥200 mL within 1 month, or ≥400 mL within 3 months prior to dosing, or who had received a blood transfusion within 8 weeks prior to dosing.
• Subjects with dysphagia; or a history of needle or blood phobia, poor venous access, or inability to tolerate venipuncture.
• Subjects deemed by the investigators to be unsuitable for the trial for any other reason.
• Subjects with any clinically significant abnormalities, as determined by the investigator, in physical examination, vital signs, laboratory tests (including hematology, urinalysis, blood biochemistry, coagulation), chest imaging, abdominal ultrasonography, or electrocardiogram.
• Subjects who tested positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody or HIV antibody.
• Subjects with a known or suspected allergy to the investigational drug or its excipients, or a history of severe allergic reactions (e.g., to drugs, food, toxins).
• Subjects with any active autoimmune disease or immunodeficiency at screening.
• Subjects with any history of severe clinical disease, or any condition that, in the investigator's judgment, could compromise trial outcomes, affect drug absorption, distribution, metabolism, or excretion (pharmacokinetics), or pose an undue risk to the subject. This includes, but is not limited to, significant disorders of the circulatory, endocrine, nervous, digestive, urinary, hematological, immune, psychiatric, or metabolic systems.
• Subjects who had undergone any surgery within 3 months prior to screening, had not fully recovered as determined by the investigator, or planned to undergo surgery during the trial or within 1 month after its completion.

Sponsors & Collaborators

• Reistone Biopharma Company Limited: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

Central Study Contacts

Ye Xu

CONTACT

+86-0518-81220121; ye.xu.yx1@hengrui.com

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: December 4, 2025
• First Posted: December 17, 2025
• Study Start: January 4, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

CN (1)