A Study to See How Safe and Tolerable Different Doses of REGN13335 Are When Administered Intravenously (IV) or Subcutaneously (SC) to Healthy Adult Participants
NCT ID: NCT06137482
Last Updated: 2025-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
56 participants
INTERVENTIONAL
2023-12-06
2025-02-11
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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IV Cohort 1 Low Dose
Randomized as described in the protocol
REGN13335
Administered intravenous (IV) or subcutaneous (SC), sequential ascending single dose
Matching Placebo
Administered IV or SC, sequential ascending single dose
IV Cohort 2 Mid Dose
Randomized as described in the protocol
REGN13335
Administered intravenous (IV) or subcutaneous (SC), sequential ascending single dose
Matching Placebo
Administered IV or SC, sequential ascending single dose
IV Cohort 3 High Dose
Randomized as described in the protocol
REGN13335
Administered intravenous (IV) or subcutaneous (SC), sequential ascending single dose
Matching Placebo
Administered IV or SC, sequential ascending single dose
IV Cohort 4 Higher Dose
Randomized as described in the protocol
REGN13335
Administered intravenous (IV) or subcutaneous (SC), sequential ascending single dose
Matching Placebo
Administered IV or SC, sequential ascending single dose
IV Cohort 5 Highest Dose
Randomized as described in the protocol
REGN13335
Administered intravenous (IV) or subcutaneous (SC), sequential ascending single dose
Matching Placebo
Administered IV or SC, sequential ascending single dose
SC Cohort 1 Low Dose
Randomized as described in the protocol
REGN13335
Administered intravenous (IV) or subcutaneous (SC), sequential ascending single dose
Matching Placebo
Administered IV or SC, sequential ascending single dose
SC Cohort 2 High Dose
Randomized as described in the protocol
REGN13335
Administered intravenous (IV) or subcutaneous (SC), sequential ascending single dose
Matching Placebo
Administered IV or SC, sequential ascending single dose
IV or SC Optional Cohort
≤ Highest IV or SC Dose as described in the protocol Randomized as described in the protocol
REGN13335
Administered intravenous (IV) or subcutaneous (SC), sequential ascending single dose
Matching Placebo
Administered IV or SC, sequential ascending single dose
Interventions
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REGN13335
Administered intravenous (IV) or subcutaneous (SC), sequential ascending single dose
Matching Placebo
Administered IV or SC, sequential ascending single dose
Eligibility Criteria
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Inclusion Criteria
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)
Exclusion Criteria
18 Years
55 Years
ALL
Yes
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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New Zealand Clinical Research
Christchurch, Canterbury, New Zealand
Countries
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Other Identifiers
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R13335-HV-2289
Identifier Type: -
Identifier Source: org_study_id
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