Study Evaluating the Safety and Tolerability of RCT1100 in Healthy Subjects
Study Details
Study Description
Brief Summary
This is the first-in-human study with RCT1100 and is designed to provide initial safety and tolerability data for future clinical studies.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
The primary objective of this study is to assess the safety and tolerability of a single ascending dose of inhaled RCT1100 administered via nebulizer to healthy participants.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: RCT1100 Drug: RCT1100 single dose |
Drug: RCT1100
RCT1100 supplied as varying dose strengths administered using PARI eFlow® Nebulizer System
|
| Placebo Comparator: Placebo Drug: Placebo single dose |
Other: Placebo
Placebo of similar volumes to experimental dose strengths administered using PARI eFlow® Nebulizer System
|
Outcome Measures
Primary Outcome Measures
- The number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs). [From Baseline Through Day 28]
Safety and tolerability as assessed by number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs).
Eligibility Criteria
Criteria
Major Inclusion Criteria:
-
Healthy, adult, male or female of non childbearing potential only, 18-55 years of age, inclusive, at screening.
-
Body mass index (BMI) ≥ 18 and ≤ 35 kg/m2 at screening, and a total body weight ≥ 50 kg
-
The participant has a forced expiratory volume in one second (FEV1) of at least 80% predicted
-
The participant is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening.
-
Understands the study procedures in the informed consent form (ICF), and is willing and able to comply with the protocol.
Major Exclusion Criteria:
-
History or presence of clinically significant medical, surgical, clinical laboratory, or psychiatric condition or disease.
-
The participant has supine blood pressure (BP) >150 mm Hg (systolic) or >90 mm Hg (diastolic), following at least 5 minutes of supine rest.
-
The participant has abnormal clinical laboratory tests at screening, as assessed by the study-specific laboratory.
-
The participant is a smoker or has used nicotine or nicotine-containing products 6 weeks before the first dose of study drug. Former smokers with greater than 10 pack years of smoking history are excluded.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | New Zealand Clinical Research | Auckland | New Zealand |
Sponsors and Collaborators
- ReCode Therapeutics
Investigators
- Principal Investigator: Paul Hamilton, New Zealand Clinical Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RCT1100-101