Actively Recruiting
A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of RSN0402 in Healthy Volunteers
Led by Shenzhen Resproly Biopharmaceutical Co., Ltd · Updated on 2024-07-08
72
Participants Needed
3
Research Sites
6 weeks
Total Duration
On this page
Sponsors
S
Shenzhen Resproly Biopharmaceutical Co., Ltd
Lead Sponsor
R
Resproly Australia Pty Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a phase 1, randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of RSN0402 in healthy volunteers. This first-in-human trial aims to understand how the drug behaves in the body and its potential effects, enrolling about 72 participants aged 18 to 60 years. The study is sponsored by Shenzhen Resproly Biopharmaceutical Co., Ltd and focuses on healthy adults without significant medical conditions. The study has three parts: the Single Ascending Dose (SAD) part, where participants receive a single inhaled dose of RSN0402 at varying levels (2, 4, 8, 12, or 16 mg) or placebo; the Multiple Ascending Dose (MAD) part, where participants receive daily doses of RSN0402 or placebo for seven days at doses of 4, 8, 12, or 16 mg; and an additional dose administration of 150 mg nintedanib soft capsule for one cohort after a washout period. Dose adjustments may be made based on safety and pharmacokinetic data during the study. Participants will be closely monitored through clinical exams, lung function tests, blood and urine samples, vital signs, ECGs, and questionnaires at scheduled visits throughout the study duration. Researchers will track treatment-emergent adverse events and changes in physical, laboratory, and lung function parameters. Pharmacokinetic measurements will be collected at multiple time points to assess drug absorption and elimination. The study includes a safety review committee to guide dosing decisions and ensure participant well-being until the study's end in February 2025.
CONDITIONS
Brief Title
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of RSN0402 in Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is overtly healthy or has no clinically significant condition based on medical history, vital signs, ECG, lab tests, and physical exam at screening and admission.
- Normal lung function with FEV1 at least 80% predicted and FEV1/FVC ratio greater than 0.7.
- Willing and able to participate voluntarily for the entire study and follow all protocol requirements.
- Age between 18 and 60 years inclusive at consent.
- Male participants weighing at least 50 kg; female participants weighing at least 45 kg; BMI between 18 and less than 30 kg/m2.
- Female participants of childbearing potential must have negative pregnancy tests at screening and baseline and agree to use contraception.
- Male participants agree to use contraception if their partner could become pregnant from consent until 3 months after end of study.
You will not qualify if you...
- Vulnerable participants under administrative or legal supervision.
- Evidence or diagnosis of HIV, hepatitis C, or chronic hepatitis B infection.
- Significant cardiovascular, renal, hepatic, blood, gastrointestinal, lung, metabolic, neurological, or psychiatric disease within last 2 years or active airway infection.
- Known allergy or intolerance to the drug or its excipients, including lactose.
- History of vasovagal syncope within past 5 years.
- History of anaphylaxis or seizures.
- Bleeding disorders or current use of anticoagulants, aspirin, or NSAIDs.
- Thrombotic events within 6 months prior to screening.
- Pulmonary arterial hypertension.
- Severe or unstable cardiovascular disease.
- Recent gastrointestinal surgery (except minor).
- Need for regular medications during study except occasional paracetamol or ibuprofen.
- Use of medications affecting study outcomes or CYP3A4 inducers/inhibitors within specified timeframes.
- Use of other investigational drugs within 30 days.
- Abnormal lab or physical findings that pose health risks.
- Abnormal ECG findings including prolonged QTc.
- Elevated liver enzymes or bilirubin.
- Pregnant or breastfeeding women.
- Women of childbearing potential not using effective contraception.
- Positive drug or alcohol abuse tests or history.
- Use of tobacco or nicotine products within 3 months.
- Consumption of grapefruit, alcohol, or caffeine within 48 hours prior to confinement.
- Recent significant blood donation or loss.
- Unsuitable veins for blood sampling.
- Inability to learn inhalation technique.
- Anticipated poor compliance or other reasons judged by investigator for ineligibility.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Multiple visits during screening period
Duration - 1 day
Participants undergo a 10-hour fast before dosing for proper preparation.
1 visit (in-person) for fasting and baseline assessments
Duration - Up to 14 days
Participants receive a single dose of RSN0402 or placebo via inhalation. Cohort 2 also receives a single oral dose of nintedanib after a 7-day washout period.
Multiple visits for dosing and follow-up assessments over 14 days
Duration - 7 days of dosing plus follow-up to Day 13
Participants receive multiple doses of RSN0402 or placebo once daily for 7 days following a 10-hour fast before dosing each day.
Daily visits for 7 days of dosing and additional follow-up visits up to Day 13
Duration - Up to 13 days post treatment
Participants are monitored for safety, tolerability, and pharmacokinetics after dosing ends.
Several follow-up visits post last dose depending on cohort
Trial Site Locations
Total: 3 locations
1
Nucleus Network Pty Ltd
Geelong, Victoria, Australia, 3220
Actively Recruiting
2
Nucleus Network
Melbourne, Victoria, Australia, 3004
Actively Recruiting
3
Nucleus Network Pty Ltd
Melbourne, Australia, 3004
Actively Recruiting
Research Team
Y
Yiqing Cui
S
Shugui He
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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