A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
Active_not_recruiting
Phase 1Phase 2Interventional Study
Hereditary Hemorrhagic Telangiectasia
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
89
Sponsor
Alnylam Pharmaceuticals · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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
Trial Locations
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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 vi…
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
Contacts
No contact information available.
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