RecruitingPhase 1

A Clinical Study of RSS0343 in Healthy Subjects

China48 participantsStarted 2026-01-04

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Incidence and severity of any adverse events (AEs).

Timeframe: Evaluation was performed up to Day 28.

Trial details

NCT IDNCT07289464

SponsorReistone Biopharma Company Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09

Contact for this trial

Ye Xu

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

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