NCT06659640 A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
| NCT ID | NCT06659640 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Alnylam Pharmaceuticals |
| Condition | Hereditary Hemorrhagic Telangiectasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-11-07 |
| Primary Completion | 2028-01-05 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
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