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RCT1100 for Primary Ciliary Dyskinesia

Phase 1
Recruiting
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

Study 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).Check my eligibility
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.See study design
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

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

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
3 Previous Clinical Trials
232 Total Patients Enrolled
John Matthews, MBBS, MCRP, PhDStudy ChairReCode Therapeutics, Inc.
Paul HamiltonPrincipal InvestigatorNew Zealand Clinical Research
1 Previous Clinical Trials
34 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the eligibility criteria for this experiment restricted to adults aged 55 and over?

"This study is accessible to adults aged 18-65."

Answered by AI

Is it feasible for me to partake in this research trial?

"The criteria for enrolment into this trial dictates that participants must be afflicted with primary ciliary dyskinesia and between 18 to 65 years old. 9 individuals will have the opportunity to participate in this medical study."

Answered by AI

Is this research endeavor presently open to new participants?

"According to information accessible through clinicaltrials.gov, this trial is currently looking for participants. It was launched on February 18th of 2023 and underwent its most recent update in December 11th of the same year."

Answered by AI

How many test sites have been designated for this trial?

"This research is currently enrolling participants from 4 sites in Philadelphia, Sydney, London and other locales. It would be prudent to select the nearest clinic for ease of access when signing up."

Answered by AI

Has RCT1100 received authorization from the Food and Drug Administration?

"Due to the limited data currently available, RCT1100 has been assigned a safety rating of 1 on our scale. This is consistent with its Phase 1 status, which implies that there have only been preliminary studies evaluating efficacy and safety."

Answered by AI

How many individuals are being enlisted for this clinical trial?

"To successfully conduct this study, ReCode Therapeutics will need to recruit 9 qualified participants. Recruitment efforts are taking place at University of Pennsylvania in Philadelphia and Macquarie University in Sydney, New South Wales."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study Evaluating the Safety and Tolerability of RCT1100 in Healthy and PCD Subjects
2023. "Study Evaluating the Safety and Tolerability of RCT1100 in Healthy and PCD Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05737485.
~2 spots leftby Sep 2024
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