A First In Human (FIH) Study to Learn if Different Doses of ALN-ANG3 Are Safe and Well Tolerated in Healthy Adults
- Sponsor
- Regeneron Pharmaceuticals
- Study ID
- NCT06452771
- Phase
- PHASE1
- Status
- Active Not Recruiting
Conditions
- Healthy Volunteers With Hyperlipidemia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Accepted
Interventions
- ALN-ANG3 — DRUGAdministered per the protocol
- Placebo (PB) — DRUGAdministered per the protocol
Study Details
This study is researching an experimental drug called ALN-ANG3 (called "study drug"). The study is focused on healthy participants with an elevated level of blood lipids (eg, cholesterol and triglycerides). The aim of the study is to see how safe and tolerable the study drug is in healthy adult participants. 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 in the blood 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)
Key Dates
- Start date
- Jun 27, 2024
- Status verified
- Feb 2026
- Primary completion
- Dec 4, 2026
- Completion
- Dec 4, 2026
Study Design
- Enrollment
- 59 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Part A: Cohorts
- Experimental: Part B: Cohorts
Primary Outcome Measure
Incidence of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to Approximately 323 Days ]