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

About this trial

Last updated 23 days ago

Study ID

ALN-6400-001

Status

Recruiting

Type

Interventional

Phase

Phase 1

Placebo

Yes

Accepting

2 to 4 Years

Female

Trial Timing

Started a year ago

What is this trial about?

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

What are the participation requirements?

Inclusion Criteria

Part A: * Is a healthy adult volunteer Part B: * Is an adult patient with a clinical diagnosis of HHT

Exclusion Criteria

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 Note: other protocol defined inclusion / exclusion criteria apply

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For more information, view the full study details:

NCT06659640