RECRUITING

A Phase 1 Study Evaluating Safety and Tolerability of RCT2100 in Healthy Participants and in Participants With CF

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is the first-in-human study with RCT2100 and is designed to provide safety and tolerability data for future clinical studies.

Official Title

A Phase 1/2, Multicenter Study Evaluating the Safety, Tolerability, and Biodistribution of RCT2100 With Single-Ascending Doses in Healthy Participants and Multiple-Ascending Doses and Proof-of-Concept in Participants With Cystic Fibrosis

Quick Facts

Study Start:2024-02-01

Study Completion:2025-12-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06237335

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Healthy, adult, male or female, 18-55 years of age, inclusive, at screening. * Body weight greater than or equal to 50 kg and body mass index (BMI) between 16-32 kg/m2, inclusive * 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.	* 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.

Inclusion Criteria

Exclusion Criteria

* Healthy, adult, male or female, 18-55 years of age, inclusive, at screening.
* Body weight greater than or equal to 50 kg and body mass index (BMI) between 16-32 kg/m2, inclusive
* 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.

* 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

Study Contact

Priya Riyali, MBA

CONTACT

650-629-7900

clinicaltrials@recodetx.com

Principal Investigator

John Matthews, MBBS, MCRP, PhD

STUDY_CHAIR

ReCode Therapeutics, Inc.

Study Locations (Sites)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294

United States

University of Arizona

Tucson, Arizona, 85719

United States

Stanford University

Palo Alto, California, 94304

United States

UCSD

San Diego, California, 92037

United States

National Jewish Health

Denver, Colorado, 80206

United States

Emory University

Atlanta, Georgia, 30322

United States

Boston Children's Hospital

Boston, Massachusetts, 02215

United States

New York Medical College

Valhalla, New York, 10595

United States

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599

United States

Oregon Health & Science University

Portland, Oregon, 97239

United States

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213

United States

UT Southwestern Medical Center

Dallas, Texas, 75390

United States

University of Washington

Seattle, Washington, 98195

United States

Collaborators and Investigators

Sponsor: ReCode Therapeutics

John Matthews, MBBS, MCRP, PhD, STUDY_CHAIR, ReCode Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-01

Study Completion Date2025-12-02

Study Record Updates

Study Start Date2024-02-01

Study Completion Date2025-12-02

Terms related to this study

Keywords Provided by Researchers

Cystic Fibrosis
CF

Additional Relevant MeSH Terms

Cystic Fibrosis