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NCT Number: NCT07295717

A Study to Evaluate ALN-4285 in Adult Healthy Volunteers

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

Recruiting

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Site

London, NW10 7EW, United Kingdom

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

ALN-4285

Drug

ALN-4285 will be administered SC

Placebo

Drug

Placebo will be administered SC

Primary outcomes

  1. Frequency of Adverse Events (AEs)

    Time frame: Up to Week 24

Secondary outcomes

  1. Concentration of ALN-4285 in Plasma

    Time frame: Up to Day 3

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trial Information Line

CONTACT

[email protected]

1-877-ALNYLAM

Clinical Trial Information Line

CONTACT

[email protected]

1-877-256-9526

Sponsors and collaborators

Lead sponsor

Alnylam Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 22, 2025
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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