Safety, Tolerability, and Pharmacokinetics of REGN5069 in Healthy Volunteers

Study Overview
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Brief Summary
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The primary objective of the study is to evaluate the safety and tolerability of single ascending doses of REGN5069 administered intravenously (IV) and subcutaneously (SC) in healthy male and female participants. The secondary objectives of the study are to characterize the pharmacokinetics (PK) profile of single IV and SC doses of REGN5069 in healthy participants and assess the immunogenicity of REGN5069 in healthy participants administered single IV or SC doses of REGN5069

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Intravenously or Subcutaneously Administered REGN5069 in Healthy Volunteers

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: REGN5069
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Participant is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and ECG performed at screening and/or prior to study drug dosing Participant is in good health based on laboratory safety testing obtained at the screening visit Willing and able to comply with clinic visits and study-related procedures Provide informed consent signed by study participant or legally acceptable representative Key Exclusion Criteria: History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease Has any physical examination findings and/or history of any illness that might confound the results of the study or poses an additional risk to the subject by study participation Hospitalization for any reason within 60 days of the screening visit Current cigarette smoker or former smoker (cigarettes or e-cigarettes) who stopped smoking within 3 months prior to screening History of drug or alcohol abuse within a year prior to the screening visit Presence of HIV, hepatitis B, or hepatitis C seropositivity at screening or within 3 months prior to dosing with the exception of false positive screening tests as documented by polymerase chain reaction or Western blot Any malignancy within the past 5 years, except for basal cell or squamous epithelial cell carcinomas of the skin or carcinoma in situ of the cervix or anus, that have been resected, with no evidence of metastatic disease for 3 years Note: Other protocol Inclusion/Exclusion Criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Cohort 1 will receive a single IV dose of REGN5069 or matching placebo | Drug: REGN5069<br>* REGN5069 will be administered by IV infusion or SC injection<br>Drug: Placebo<br>* Placebo-matching REGN5069<br>|
| Experimental: Cohort 2<br>Cohort 2 will receive a single sequential ascending IV dose of REGN5069 or matching placebo | Drug: REGN5069<br>* REGN5069 will be administered by IV infusion or SC injection<br>Drug: Placebo<br>* Placebo-matching REGN5069<br>|
| Experimental: Cohort 3<br>Cohort 3 will receive a single sequential ascending IV dose of REGN5069 or matching placebo | Drug: REGN5069<br>* REGN5069 will be administered by IV infusion or SC injection<br>Drug: Placebo<br>* Placebo-matching REGN5069<br>|
| Experimental: Cohort 4<br>Cohort 4 will receive a single sequential ascending IV dose of REGN5069 or matching placebo | Drug: REGN5069<br>* REGN5069 will be administered by IV infusion or SC injection<br>Drug: Placebo<br>* Placebo-matching REGN5069<br>|
| Experimental: Cohort 5<br>Cohort 5 will receive a single SC dose of REGN5069 or matching placebo | Drug: REGN5069<br>* REGN5069 will be administered by IV infusion or SC injection<br>Drug: Placebo<br>* Placebo-matching REGN5069<br>|
| Experimental: Cohort 6<br>Cohort 6 will receive a single sequential ascending SC dose of REGN5069 or matching placebo | Drug: REGN5069<br>* REGN5069 will be administered by IV infusion or SC injection<br>Drug: Placebo<br>* Placebo-matching REGN5069<br>|
| Experimental: Cohort 7<br>Cohort 7 will receive a single sequential ascending IV dose of REGN5069 or matching placebo | Drug: REGN5069<br>* REGN5069 will be administered by IV infusion or SC injection<br>Drug: Placebo<br>* Placebo-matching REGN5069<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of treatment-emergent adverse events (TEAEs) |  | From baseline up to week 36 | 
| Incidence of laboratory abnormalities | As measured by chemistry, hematology and urinalysis | From baseline up to week 36 | 
| Incidence of vital signs abnormalties | As measured by heart rate, blood pressure, body temperature and respiratory rate | From baseline up to week 36 | 
| Incidence of standard 12-lead electrocardiogram (ECG) abnormalties | As measured by heart rate, PR, complex of Q, R, and S waves [QRS], QT-intervals, and QTc | From baseline up to week 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of REGN5069 in serum over time |  | From baseline up to week 36 | 
| Incidence of anti-drug antibody (ADA) |  | From baseline up to week 36 |