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A Clinical Study of RSS0343 in Healthy Subjects | Clinical Trials | Clareo Health

RECRUITINGPHASE1

A Clinical Study of RSS0343 in Healthy Subjects

A Randomized, Double-blind, Placebo-controlled Phase I Clinical 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

NCT07289464•Reistone Biopharma Company Limited

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Subjects who provided written informed consent after being fully informed of the trial's purpose, significance, and protocol requirements.
•2. Healthy individuals aged 18 to 55 years, inclusive. Males and females
•3. 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.
•4. 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.

Exclusion Criteria

•1. 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.
•2. 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.
•3. Subjects with a history of, or current, drug abuse, or drug dependence (during consultation), or with a positive urine drug screening result.
•4. 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.
•5. Subjects with dysphagia; or a history of needle or blood phobia, poor venous access, or inability to tolerate venipuncture.
•6. Subjects deemed by the investigators to be unsuitable for the trial for any other reason.
•7. 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.
•8. Subjects who tested positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody or HIV antibody.
•9. 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).
•10. Subjects with any active autoimmune disease or immunodeficiency at screening.
+2 more criteria

Locations (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Key Dates

Start Date

January 4, 2026

Primary Completion Date

September 1, 2026

Completion Date

September 1, 2026

Last Updated

January 14, 2026

Enrollment

ESTIMATED participants

Conditions

Non-cystic Fibrosis Bronchiectasis

Interventions

RSS0343 Tablets

DRUG

RSS0343 Tablets Placebo

DRUG

Contacts

Ye Xu

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 14, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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