RECRUITING

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

Description

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

Conditions

Cystic Fibrosis
Talk to us

Related Conditions:

Cystic Fibrosis

Study Overview

On this page

Study Details

Study overview

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

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

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

Condition
Cystic Fibrosis
Intervention / Treatment

-

Contacts and Locations

Birmingham

The University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294

Tucson

University of Arizona, Tucson, Arizona, United States, 85719

Palo Alto

Stanford University, Palo Alto, California, United States, 94304

San Diego

UCSD, San Diego, California, United States, 92037

Denver

National Jewish Health, Denver, Colorado, United States, 80206

Atlanta

Emory University, Atlanta, Georgia, United States, 30322

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02215

Valhalla

New York Medical College, Valhalla, New York, United States, 10595

Chapel Hill

The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States, 27599

Portland

Oregon Health & Science University, Portland, Oregon, United States, 97239

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

ReCode Therapeutics,

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

Study Record Dates

2025-12-02