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Study Evaluating the Safety and Tolerability of RCT1100 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05737485
Recruitment Status : Recruiting
First Posted : February 21, 2023
Last Update Posted : March 29, 2023
Information provided by (Responsible Party):
ReCode Therapeutics

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
Primary Ciliary Dyskinesia Drug: RCT1100 Other: Placebo 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
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

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

Primary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

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

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Contact: Priya Ryali, MBA (650) 629-7900 clinicaltrials@recodetx.com
Contact: Cortney Miller (617) 539-8653 clinicaltrials@recodetx.com

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New Zealand
New Zealand Clinical Research Recruiting
Auckland, New Zealand
Contact: Paul Hamilton, MD    +64 9 373 3474      
Sponsors and Collaborators
ReCode Therapeutics
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Principal Investigator: Paul Hamilton New Zealand Clinical Research
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Responsible Party: ReCode Therapeutics
ClinicalTrials.gov Identifier: NCT05737485    
Other Study ID Numbers: RCT1100-101
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ReCode Therapeutics:
Primary Ciliary Dyskinesia
Kartagener Syndrome
Additional relevant MeSH terms:
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Ciliary Motility Disorders
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn