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

Cystic Fibrosis Clinical Trial

Official title:

A Phase 1, Single-Center Study Evaluating the Safety, Tolerability, and Biodistribution of RCT2100 With Single-Ascending Doses in Healthy Participants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06237335
• Other study ID #: RCT2100-101
• Status: Recruiting
• Phase: Phase 1
• Start date: February 1, 2024
• Est. completion date: August 17, 2024

Study information

• Verified date: May 2024
• Source: ReCode Therapeutics
• Contact: Cheri Piscia-Nichols
• Phone: +1-650-629-7900
• Email: clinicaltrials[@]recodetx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

The primary objective of this study is to assess the safety, tolerability, and biodistribution of a single ascending dose of inhaled RCT2100 administered via nebulizer to healthy participants

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: August 17, 2024
• Est. primary completion date: May 17, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Major Inclusion 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.

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• RCT2100
RCT2100 supplied as varying dose strengths administered via oral inhalation using nebulizer

Other:
• Placebo
Placebo of similar volumes to experimental dose strengths administered via oral inhalation using nebulizer

Locations

Country	Name	City	State
New Zealand	New Zealand Clinical Research	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
ReCode Therapeutics

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	From Baseline Through Day 29