Actively Recruiting
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of RSN0402 in Healthy Volunteers
Led by Shenzhen Resproly Biopharmaceutical Co., Ltd · Updated on 2024-07-08
72
Participants Needed
3
Research Sites
30 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
This is a phase 1, randomized, First in Human (FIH), double-blinded, placebo-controlled study to assess the safety, tolerability, and PK of RSN0402 in healthy volunteers. A total of about 72 participants are expected to be enrolled.
CONDITIONS
Official 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 as determined by medical history, vital signs, ECG, laboratory tests, and physical examination at Screening and admission.
- Normal lung function with FEV1 of at least 80% predicted and FEV1/FVC ratio greater than 0.7.
- Willingness to participate voluntarily for the entire study duration and adhere to all protocol requirements.
- Age between 18 and 60 years inclusive at the time of informed consent.
- Male participants with body weight at least 50.0 kg, female participants with body weight at least 45.0 kg.
- Body mass index (BMI) between 18 and less than 30 kg/m2 at screening.
- Female participants of childbearing potential must have negative serum pregnancy tests at Screening and Baseline and agree to use acceptable contraception.
- Male participants must agree to use acceptable contraception if their partner could become pregnant from consent until 3 months after study end.
You will not qualify if you...
- Vulnerable participants under any administrative or legal supervision.
- Clinical evidence or diagnosis of HIV, hepatitis C, or chronic hepatitis B infection.
- Clinically significant cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, or psychiatric disease within 2 years or active airway infection.
- Known hypersensitivity or intolerance to study drug or its excipients including lactose.
- History of vasovagal syncope in past 5 years.
- History of anaphylactic or anaphylactoid reactions.
- History of seizures including febrile seizures.
- History of bleeding disorders or current use of anticoagulants, aspirin, or NSAIDs.
- History of thrombotic event within 6 months before screening.
- History of pulmonary arterial hypertension.
- Severe uncontrolled hypertension or history of myocardial infarction or unstable angina.
- Prior gastrointestinal surgery except appendectomy or simple hernia repair.
- Regular or likely need for concomitant treatments except occasional paracetamol or ibuprofen.
- Use of medications affecting study outcome except allowed contraceptives or hormone therapy.
- Use of drugs prolonging QT/QTc interval within specified timeframes before dosing.
- Participation in another investigational drug study within 30 days before dosing.
- Clinically significant abnormal lab values or vital signs outside specified ranges.
- Abnormal ECG findings with prolonged QTc intervals.
- Elevated liver enzymes or bilirubin above 1.5 times upper limit of normal.
- Pregnant or lactating females.
- Women of childbearing potential not using acceptable contraception.
- Positive drug abuse test or history of drug abuse.
- History of alcohol abuse or positive alcohol breath test.
- Use of tobacco or nicotine products within 3 months before screening or positive urine cotinine test.
- Consumption of grapefruit, pomelo, alcohol, or caffeine within 48 hours before and during confinement.
- Recent significant blood donation or loss.
- Unsuitable veins for blood sampling.
- Inability to learn inhalation technique.
- Predictable poor compliance.
- Other reasons judged by investigator or sponsor making participant ineligible.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
S
Shugui He
CONTACT
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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