Healthy Volunteers
Conditions
Brief summary
The purpose of this study is to study the safety and tolerability of intravenous (IV) and subcutaneous (SC) administration of REGN1154 in normal healthy subjects.
Interventions
DRUGREGN1154 or placebo
Participants will receive active drug or placebo
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy men and women between the ages of 18 and 65; women must be postmenopausal or surgically sterile 2. Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive 3. Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures 4. Able to read or to understand the consent process, and willing to sign the informed consent form (ICF)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total number and severity of TEAEs | Day 1 through Day 113 | TEAEs (Treatment-emergent adverse events) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum concentration | Day 1 through Day 113 | Serum concentrations of REGN1154 over time |
| Presence or absence of antibodies | Day 1 through Day 113 | Presence or absence of antibodies against REGN1154 over time. |
Countries
Australia
Outcome results
None listed