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CompletedNCT07289464Updated Aug 17, 2026

A Clinical Study of RSS0343 in Healthy Subjects

A Phase 1 interventional study of RSS0343 Tablets and RSS0343 Tablets Placebo in Non-cystic Fibrosis Bronchiectasis, sponsored by Reistone Biopharma Company Limited. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by Reistone Biopharma Company Limited · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Non-cystic Fibrosis Bronchiectasis
03

In context

Lead sponsor

Reistone Biopharma Company Limited is the lead sponsor of 16 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts 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

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.
  11. 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.
  12. 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    RSS0343 Tablets Group

    Drug: RSS0343 Tablets

  • Placebo comparator
    RSS0343 Tablets Placebo Group

    Drug: RSS0343 Tablets Placebo

Interventions

  • DrugRSS0343 Tablets

    RSS0343 tablets, oral.

  • DrugRSS0343 Tablets Placebo

    RSS0343 tablets placebo, oral.

06

What researchers measure

Primary outcomes

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

    Safety and tolerability.

    Time frame: Evaluation was performed up to Day 28.

Secondary outcomes

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

    Pharmacokinetics (PK) indicator.

    Time frame: Evaluation was performed up to Day 28.

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

    Pharmacokinetics (PK) indicator.

    Time frame: Evaluation was performed up to Day 28.

  3. Time to Cmax (Tmax).

    Pharmacokinetics (PK) indicator.

    Time frame: Evaluation was performed up to Day 28.

  4. Time to Cmax,ss (Tmax,ss).

    Pharmacokinetics (PK) indicator.

    Time frame: Evaluation was performed up to Day 28.

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

    Pharmacokinetics (PK) indicator.

    Time frame: Evaluation was performed up to Day 28.

  6. Area under the concentration-time curve from 0 to the last measurable time point after RSS0343 administration (AUC0-t).

    Pharmacokinetics (PK) indicator.

    Time frame: Evaluation was performed up to Day 28.

  7. Area under the concentration-time curve from time 0 to infinity after RSS0343 administration (AUC0-inf).

    Pharmacokinetics (PK) indicator.

    Time frame: Evaluation was performed up to Day 28.

  8. Terminal elimination half-life of RSS0343 (t1/2).

    Pharmacokinetics (PK) indicator.

    Time frame: Evaluation was performed up to Day 28.

  9. Apparent clearance of RSS0343 during multiple dosing with a dosing interval of time tau (CLss/F).

    Pharmacokinetics (PK) indicator.

    Time frame: Evaluation was performed up to Day 28.

  10. Apparent volume of distribution during terminal elimination phase of RSS0343 at steady state (Vss/F).

    Pharmacokinetics (PK) indicator.

    Time frame: Evaluation was performed up to Day 28.

  11. Cumulative amount of drug excreted in urine (Ae,urine).

    Pharmacokinetics (PK) indicator.

    Time frame: Evaluation was performed up to Day 28.

  12. Cumulative percentage of dose recovered in urine (Fe,urine).

    Pharmacokinetics (PK) indicator.

    Time frame: Evaluation was performed up to Day 28.

  13. Renal clearance of RSS0343 (CLr).

    Pharmacokinetics (PK) indicator.

    Time frame: Evaluation was performed up to Day 28.

  14. Changes in the QTc interval corrected by the Fridericia method relative to baseline (ΔQTcF) (where applicable).

    To evaluate the effects of RSS0343 on the QT/QTc interval in healthy subjects.

    Time frame: Evaluation was performed up to Day 28.

07

Study locations

1 site
  • Zhongnan Hospital of Wuhan University
    Wuhan, Hubei 430071, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07289464
Lead sponsor
Reistone Biopharma Company Limited
Responsible party
Sponsor
First posted
Dec 17, 2025
Start date
Jan 8, 2026
Primary completion
Aug 10, 2026
Completion
Aug 10, 2026
Last update
Aug 17, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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