NCT06452771

A First In Human (FIH) Study to Learn if Different Doses of ALN-ANG3 Are Safe and Well Tolerated in Healthy Adults

A Phase 1, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, and Pharmacokinetics of ALN-ANG3 in Otherwise Healthy Adult Participants

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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)

Detailed description

This is a 2-Part study. Participants in Part A are excluded from participation in Part B

Conditions

• Healthy Volunteers With Hyperlipidemia

Interventions

Type	Name	Description
DRUG	ALN-ANG3	Administered per the protocol
DRUG	Placebo (PB)	Administered per the protocol

Timeline

• Start date: 2024-06-27
• Primary completion: 2026-12-04
• Completion: 2026-12-04
• First posted: 2024-06-11
• Last updated: 2026-02-20

Locations

1 site across 1 country: New Zealand

Regulatory

• FDA-regulated drug study