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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
Date last updated
9/05/2024

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 (6:2) to REGN13335 or placebo

Experimental: IV Cohort 2 Mid Dose - Randomized (6:2) to REGN13335 or placebo

Experimental: IV Cohort 3 High Dose - Randomized (6:2) to REGN13335 or placebo

Experimental: IV Cohort 4 Higher Dose - Randomized (6:2) to REGN13335 or placebo

Experimental: SC Cohort 1 Low Dose - Randomized (6:2) to REGN13335 or placebo

Experimental: SC Cohort 2 High Dose - Randomized (6:2) to REGN13335 or placebo

Experimental: IV or SC Optional Cohort 1 - Randomized (6:2) to REGN13335 or placebo

Experimental: IV or SC Optional Cohort 2 - Randomized (6:2) to REGN13335 or placebo


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)
Timepoint [1] 0 0
Baseline to day 113
Primary outcome [2] 0 0
Severity of TEAE's through the EOS
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
12/09/2024
Actual
Sample size
Target
Accrual to date
Final
48
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
This study is researching an experimental drug called REGN13335. This is the first time that REGN13335 will be given to people. This study will enroll healthy adults.

The aim of the study is to see how safe and tolerable REGN13335 is in healthy volunteers.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug
* How much study drug is present in the blood of study participants at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Trial website
https://clinicaltrials.gov/study/NCT06137482
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06137482