A Clinical Study of RSS0343 in Healthy Subjects
ConditionNon-cystic Fibrosis Bronchiectasis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorReistone Biopharma Company Limited
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
RSS0343 Tablets
DrugRSS0343 tablets, oral.
RSS0343 Tablets Placebo
DrugRSS0343 tablets placebo, oral.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: RSS0343 Tablets GroupExperimental treatment 1 intervention
Group B: RSS0343 Tablets Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
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.Sponsors and contacts
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Source ClinicalTrials.gov