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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
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Scientific title
A Phase 1, Single-Center Study Evaluating the Safety, Tolerability, and Biodistribution of RCT2100 With Single-Ascending Doses in Healthy Participants
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Secondary ID [1]
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RCT2100-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Cystic fibrosis
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Respiratory
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Other respiratory disorders / diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Connective tissue diseases
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs).
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Assessment method [1]
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Safety and tolerability as assessed by number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Timepoint [1]
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From Baseline Through Day 29
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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
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
17/08/2024
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Actual
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Sample size
Target
32
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
ReCode Therapeutics
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06237335
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Cheri Piscia-Nichols
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Address
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Country
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Phone
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+1-650-629-7900
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06237335
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