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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06237335




Registration number
NCT06237335
Ethics application status
Date submitted
23/01/2024
Date registered
1/02/2024
Date last updated
8/05/2024

Titles & IDs
Public title
A Phase 1 Study Evaluating Safety and Tolerability of RCT2100 in Healthy Participants
Scientific title
A Phase 1, Single-Center Study Evaluating the Safety, Tolerability, and Biodistribution of RCT2100 With Single-Ascending Doses in Healthy Participants
Secondary ID [1] 0 0
RCT2100-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Cystic fibrosis
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RCT2100
Other interventions - Placebo

Experimental: RCT2100 - RCT2100 single dose

Placebo Comparator: Placebo - Placebo single dose


Treatment: Drugs: RCT2100
RCT2100 supplied as varying dose strengths administered via oral inhalation using nebulizer

Other interventions: Placebo
Placebo of similar volumes to experimental dose strengths administered via oral inhalation using nebulizer
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs).
Timepoint [1] 0 0
From Baseline Through Day 29

Eligibility
Key inclusion criteria
Major

- 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/08/2024
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ReCode Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is the first-in-human study with RCT2100 and is designed to provide safety and
tolerability data for future clinical studies.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06237335
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Cheri Piscia-Nichols
Address 0 0
Country 0 0
Phone 0 0
+1-650-629-7900
Fax 0 0
Email 0 0
clinicaltrials@recodetx.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06237335