RecruitingPhase 1NCT07295717

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


Sponsor

Alnylam Pharmaceuticals

Enrollment

76 participants

Start Date

Dec 12, 2025

Study Type

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

Min Age: 18 YearsMax Age: 65 Years

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

DRUGALN-4285

ALN-4285 will be administered SC

DRUGPlacebo

Placebo will be administered SC


Locations(1)

Clinical Trial Site

London, United Kingdom

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NCT07295717


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