Study Evaluating the Safety and Tolerability of RCT1100 in Healthy Subjects
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|ClinicalTrials.gov Identifier: NCT05737485|
Recruitment Status : Recruiting
First Posted : February 21, 2023
Last Update Posted : March 29, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Primary Ciliary Dyskinesia||Drug: RCT1100 Other: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Single Ascending Dose Study Evaluating the Safety and Tolerability of RCT1100 in Healthy Subjects|
|Actual Study Start Date :||March 7, 2023|
|Estimated Primary Completion Date :||December 21, 2023|
|Estimated Study Completion Date :||December 21, 2025|
Drug: RCT1100 single dose
RCT1100 supplied as varying dose strengths administered using PARI eFlow® Nebulizer System
Placebo Comparator: Placebo
Drug: Placebo single dose
Placebo of similar volumes to experimental dose strengths administered using PARI eFlow® Nebulizer System
- The number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs). [ Time Frame: From Baseline Through Day 28 ]Safety and tolerability as assessed by number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs).
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|Ages Eligible for Study:||18 Years to 55 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05737485
|Contact: Priya Ryali, MBA||(650) email@example.com|
|Contact: Cortney Miller||(617) firstname.lastname@example.org|
|New Zealand Clinical Research||Recruiting|
|Auckland, New Zealand|
|Contact: Paul Hamilton, MD +64 9 373 3474|
|Principal Investigator:||Paul Hamilton||New Zealand Clinical Research|
|Responsible Party:||ReCode Therapeutics|
|Other Study ID Numbers:||
|First Posted:||February 21, 2023 Key Record Dates|
|Last Update Posted:||March 29, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Primary Ciliary Dyskinesia
Ciliary Motility Disorders
Central Nervous System Diseases
Nervous System Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn