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)
Alnylam Pharmaceuticals
120 participants
Nov 7, 2024
INTERVENTIONAL
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
Eligibility
Inclusion Criteria4
- Part A:
- Is a healthy adult volunteer
- Part B:
- Is an adult patient with a clinical diagnosis of HHT
Exclusion Criteria10
- Part A:
- Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > upper limit of normal (ULN)
- Has known human immunodeficiency virus (HIV) infection; or known current or chronic hepatitis C virus or hepatitis B virus infection
- Has an estimated glomerular filtration (eGFR) of <90 mL/min/1.73m\^2 at screening
- Part B:
- Has ALT or AST >2×ULN
- Has total bilirubin >1.5×ULN
- Has eGFR of <30 mL/min/1.73m\^2 at screening
- Parts A and B:
- Is not willing to comply with the contraceptive requirements during the study period
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Interventions
ALN-6400 will be administered subcutaneously (SC)
Placebo will be administered subcutaneously (SC)
Locations(16)
View Full Details on ClinicalTrials.gov
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NCT06659640