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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06137482




Registration number
NCT06137482
Ethics application status
Date submitted
13/11/2023
Date registered
18/11/2023

Titles & IDs
Public title
A Study to See How Safe and Tolerable Different Doses of REGN13335 Are When Administered Intravenously (IV) or Subcutaneously (SC) to Healthy Adult Participants
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenously or Subcutaneously Administered REGN13335, a Platelet-Derived Growth Factor-B Antagonist, in Healthy Adult Participants
Secondary ID [1] 0 0
R13335-HV-2289
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - REGN13335
Treatment: Drugs - Matching Placebo

Experimental: IV Cohort 1 Low Dose - Randomized as described in the protocol

Experimental: IV Cohort 2 Mid Dose - Randomized as described in the protocol

Experimental: IV Cohort 3 High Dose - Randomized as described in the protocol

Experimental: IV Cohort 4 Higher Dose - Randomized as described in the protocol

Experimental: IV Cohort 5 Highest Dose - Randomized as described in the protocol

Experimental: SC Cohort 1 Low Dose - Randomized as described in the protocol

Experimental: SC Cohort 2 High Dose - Randomized as described in the protocol

Experimental: IV or SC Optional Cohort - = Highest IV or SC Dose as described in the protocol Randomized as described in the protocol


Treatment: Drugs: REGN13335
Administered intravenous (IV) or subcutaneous (SC), sequential ascending single dose

Treatment: Drugs: Matching Placebo
Administered IV or SC, sequential ascending single dose
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment emergent adverse events (TEAE's) through the end of the study (EOS) visit
Timepoint [1] 0 0
Baseline to day 113
Primary outcome [2] 0 0
Severity of TEAE's through the EOS visit
Timepoint [2] 0 0
Baseline to day 113
Secondary outcome [1] 0 0
Concentrations of functional REGN13335 in plasma through the EOS visit
Timepoint [1] 0 0
Baseline to day 113
Secondary outcome [2] 0 0
Incidence of anti-drug antibodies (ADA) to single doses of REGN13335 over time
Timepoint [2] 0 0
Baseline to day 113
Secondary outcome [3] 0 0
Titer of ADA to single doses of REGN13335 over time
Timepoint [3] 0 0
Baseline to day 113

Eligibility
Key inclusion criteria
Key

1. Has a body mass index between 18 and 32 kg/m^2, inclusive, at the screening visit
2. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, laboratory safety tests, and electrocardiograms (ECGs) performed prior to administration of study drug (ie, screening and baseline visit)

Key
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator

NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply.

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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/02/2025
Actual
Sample size
Target
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Canterbury

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Regeneron Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trial Management
Address 0 0
Regeneron Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
When Regeneron has:

* received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
* made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
* the legal authority to share the data, and
* ensured the ability to protect participant privacy.
Available to whom?
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06137482