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RCT1100 for Primary Ciliary Dyskinesia

Phase 1
Waitlist Available
Led By Paul Hamilton
Research Sponsored by ReCode Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body mass index (BMI) ≥ 18 and ≤ 35 kg/m2 at screening, and a total body weight ≥ 50 kg
Healthy, adult, male or female of non childbearing potential only, 18-55 years of age, inclusive, at screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline through day 180
Awards & highlights
No Placebo-Only Group

Summary

This trial will explore a new drug's safety and tolerability in humans for the first time. #medicine

Who is the study for?
This trial is for healthy adults aged 18-55 who are not able to have children. Participants should be in good health as judged by medical history, lab tests, heart checks (ECG), and physical exams. They must understand the study's procedures, agree to follow them, have a BMI between 18 and 35 kg/m2, weigh at least 50 kg, and have normal lung function (FEV1 of at least 80% predicted).
What is being tested?
The trial is testing RCT1100 for safety and how well it's tolerated in people. It's the first time this drug is being given to humans with the goal of gathering early data that will help design future studies.
What are the potential side effects?
Since this is a first-in-human study for RCT1100, specific side effects are unknown but will be closely monitored throughout the trial to ensure participant safety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My BMI is between 18 and 35, and I weigh at least 50 kg.
Select...
I am a healthy adult between 18-55 years old and cannot have children.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline through day 180
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline through day 180 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs).

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: RCT1100Experimental Treatment1 Intervention
Drug: RCT1100 single dose

Find a Location

Who is running the clinical trial?

ReCode TherapeuticsLead Sponsor
5 Previous Clinical Trials
322 Total Patients Enrolled
John Matthews, MBBS, MCRP, PhDStudy ChairReCode Therapeutics, Inc.
3 Previous Clinical Trials
122 Total Patients Enrolled
Paul HamiltonPrincipal InvestigatorNew Zealand Clinical Research
1 Previous Clinical Trials
34 Total Patients Enrolled
~3 spots leftby Nov 2025
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