A Study to See How Safe and Tolerable Different Doses of REGN13335 Are When Administered Intravenously (IV) or Subcutaneously (SC) to Healthy Adult Participants
- Registration Number
- NCT06137482
- Lead Sponsor
- Regeneron Pharmaceuticals
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
Inclusion Criteria
- Has a body mass index between 18 and 32 kg/m^2, inclusive, at the screening visit
- 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
Exclusion Criteria
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description SC Cohort 1 Low Dose REGN13335 Randomized as described in the protocol SC Cohort 1 Low Dose Matching Placebo Randomized as described in the protocol SC Cohort 2 High Dose REGN13335 Randomized as described in the protocol SC Cohort 2 High Dose Matching Placebo Randomized as described in the protocol IV or SC Optional Cohort REGN13335 ≤ Highest IV or SC Dose as described in the protocol Randomized as described in the protocol IV or SC Optional Cohort Matching Placebo ≤ Highest IV or SC Dose as described in the protocol Randomized as described in the protocol IV Cohort 1 Low Dose REGN13335 Randomized as described in the protocol IV Cohort 1 Low Dose Matching Placebo Randomized as described in the protocol IV Cohort 2 Mid Dose REGN13335 Randomized as described in the protocol IV Cohort 2 Mid Dose Matching Placebo Randomized as described in the protocol IV Cohort 3 High Dose REGN13335 Randomized as described in the protocol IV Cohort 3 High Dose Matching Placebo Randomized as described in the protocol IV Cohort 4 Higher Dose REGN13335 Randomized as described in the protocol IV Cohort 4 Higher Dose Matching Placebo Randomized as described in the protocol IV Cohort 5 Highest Dose REGN13335 Randomized as described in the protocol IV Cohort 5 Highest Dose Matching Placebo Randomized as described in the protocol
- Primary Outcome Measures
Name Time Method Incidence of treatment emergent adverse events (TEAE's) through the end of the study (EOS) visit Baseline to day 113 Severity of TEAE's through the EOS visit Baseline to day 113
- Secondary Outcome Measures
Name Time Method Concentrations of functional REGN13335 in plasma through the EOS visit Baseline to day 113 Incidence of anti-drug antibodies (ADA) to single doses of REGN13335 over time Baseline to day 113 Titer of ADA to single doses of REGN13335 over time Baseline to day 113
Trial Locations
- Locations (1)
New Zealand Clinical Research
🇳🇿Christchurch, Canterbury, New Zealand