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

Conditions

• Hereditary Hemorrhagic Telangiectasia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• ALN-6400 — DRUG
  ALN-6400 will be administered subcutaneously (SC)
• Placebo — DRUG
  Placebo will be administered subcutaneously (SC)

Study Details

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

Key Dates

Start date

Nov 7, 2024

Status verified

May 2026

Primary completion

Jan 5, 2028

Completion

Jun 22, 2028

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part A: ALN-6400
  Participants will be administered a single dose of ALN-6400.
• Placebo Comparator: Part A: Placebo
  Participants will be administered a single dose of placebo.
• Experimental: Part B: ALN-6400
  Participants will be administered multiple doses of ALN-6400.
• Placebo Comparator: Part B: Placebo
  Participants will be administered multiple doses of placebo.

Primary Outcome Measure

Part A: Frequency of Adverse Events [ Time Frame: Up to Week 36 ]

Central Contacts

• Alnylam Clinical Trial Information Line
  1-877-ALNYLAM
  [email protected]
• Alnylam Clinical Trial Information Line
  1-877-256-9526
  [email protected]

Locations (8)

Find similar trials in Birmingham, AL

Related Studies

• Comprehensive HHT Outcomes Registry of the United States (CHORUS)
  Recruiting · Cure HHT · Birmingham, Alabama