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Study Evaluating the Safety and Tolerability of RCT1100 in Healthy Subjects

Primary Purpose

Primary Ciliary Dyskinesia

Status
Recruiting
Phase
Phase 1
Locations
New Zealand
Study Type
Interventional
Intervention
RCT1100
Placebo
Sponsored by
ReCode Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Ciliary Dyskinesia focused on measuring Primary Ciliary Dyskinesia, PCD, Kartagener Syndrome

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • New Zealand Clinical ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RCT1100

Placebo

Arm Description

Drug: RCT1100 single dose

Drug: Placebo single dose

Outcomes

Primary Outcome Measures

The number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs).
Safety and tolerability as assessed by number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs).

Secondary Outcome Measures

Full Information

First Posted
January 20, 2023
Last Updated
March 27, 2023
Sponsor
ReCode Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05737485
Brief Title
Study Evaluating the Safety and Tolerability of RCT1100 in Healthy Subjects
Official Title
A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Single Ascending Dose Study Evaluating the Safety and Tolerability of RCT1100 in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 7, 2023 (Actual)
Primary Completion Date
December 21, 2023 (Anticipated)
Study Completion Date
December 21, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ReCode Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Ciliary Dyskinesia
Keywords
Primary Ciliary Dyskinesia, PCD, Kartagener Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RCT1100
Arm Type
Experimental
Arm Description
Drug: RCT1100 single dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Drug: Placebo single dose
Intervention Type
Drug
Intervention Name(s)
RCT1100
Intervention Description
RCT1100 supplied as varying dose strengths administered using PARI eFlow® Nebulizer System
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo of similar volumes to experimental dose strengths administered using PARI eFlow® Nebulizer System
Primary Outcome Measure Information:
Title
The number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs).
Description
Safety and tolerability as assessed by number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs).
Time Frame
From Baseline Through Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Priya Ryali, MBA
Phone
(650) 629-7900
Email
clinicaltrials@recodetx.com
First Name & Middle Initial & Last Name or Official Title & Degree
Cortney Miller
Phone
(617) 539-8653
Email
clinicaltrials@recodetx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Hamilton
Organizational Affiliation
New Zealand Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Zealand Clinical Research
City
Auckland
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Hamilton, MD
Phone
+64 9 373 3474

12. IPD Sharing Statement

Plan to Share IPD
No

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Study Evaluating the Safety and Tolerability of RCT1100 in Healthy Subjects

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