NCT06659640

A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT)

InsigHHT: A Phase 1/2, Randomized, Double-blind, Placebo-controlled, 2-part Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Single Dose ALN-6400 in Adult Healthy Volunteers and Multiple Dose ALN-6400 in Adult Patients With Hereditary Hemorrhagic Telangiectasia (HHT)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Alnylam Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to: * evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of ALN-6400 in healthy volunteers * evaluate the efficacy, safety, tolerability and PD of multiple doses of ALN-6400 in adult patients with HHT

Conditions

• Hereditary Hemorrhagic Telangiectasia

Interventions

Type	Name	Description
DRUG	ALN-6400	ALN-6400 will be administered subcutaneously (SC)
DRUG	Placebo	Placebo will be administered subcutaneously (SC)

Timeline

• Start date: 2024-11-07
• Primary completion: 2028-01-05
• Completion: 2028-06-22
• First posted: 2024-10-26
• Last updated: 2026-04-03

Locations

8 sites across 5 countries: United States, Canada, France, Germany, Spain

Regulatory

• FDA-regulated drug study