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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• Judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiogram's (ECG's) performed at screening and/or prior to administration of initial dose of study drug

• Has fasting triglyceride (TG) levels \>=100 and \<500 mg/dL (1.13-5.65 mmol/L), defined as hyperlipidemia, and fasting Low-Density Lipoprotein (LDL-C) \>=70 and \<=300 mg/dL (1.81-7.76 mmol/L), defined as hyperlipidemia, during screening visit. Testing may be repeated once during the screening period in case the visit 1 levels fall outside of the required range

• Has a body mass index between 18 and 35 kg/m\^2, inclusive, at screening visit

Locations
Other Locations
New Zealand
New Zealand Clinical Research
RECRUITING
Christchurch
Contact Information
Primary
Clinical Trials Administrator
clinicaltrials@regeneron.com
844-734-6643
Time Frame
Start Date: 2024-06-27
Estimated Completion Date: 2026-12-03
Participants
Target number of participants: 88
Treatments
Experimental: Part A: Cohorts
Experimental: Part B: Cohorts
Related Therapeutic Areas
Sponsors
Leads: Regeneron Pharmaceuticals

This content was sourced from clinicaltrials.gov