A Study to Evaluate ALN-4285 in Adult Healthy Volunteers
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered ALN-4285 in Adult Healthy Volunteers
Alnylam Pharmaceuticals
76 participants
Dec 12, 2025
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to: * evaluate the safety and tolerability of single ascending doses of ALN-4285 in healthy volunteers * characterize the single-dose pharmacokinetics (PK) of ALN-4285
Eligibility
Inclusion Criteria2
- Has a body mass index (BMI) of ≥18.0 kg/m\^2 and ≤30 kg/m\^2
- Has 12-lead ECG within normal limits or with no clinically significant abnormalities in the opinion of the Investigator
Exclusion Criteria5
- Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>upper limit of normal (ULN)
- Has total bilirubin \>ULN
- Has systolic blood pressure \>140 mmHg and/or a diastolic blood pressure \>90 mmHg
- Has an estimated glomerular filtration (eGFR) of \<90 mL/min/1.73m\^2 at screening
- Has received an investigational agent within the last 30 days or 5 half-lives
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Interventions
ALN-4285 will be administered SC
Placebo will be administered SC
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07295717