A Study to Evaluate ALN-4285 in Adult Healthy Volunteers

May 12, 2026 updated by: Alnylam Pharmaceuticals

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, NW10 7EW
        • Recruiting
        • Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALN-4285
Participants will be administered ALN-4285 subcutaneously (SC)
Drug: ALN-4285
ALN-4285 will be administered SC
Placebo Comparator: Placebo
Participants will be administered placebo SC
Drug: Placebo
Placebo will be administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of Adverse Events (AEs)
Time Frame: Up to Week 24
Up to Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Concentration of ALN-4285 in Plasma
Time Frame: Up to Day 3
Up to Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alnylam Pharmaceuticals

Investigators

  • Study Director: Medical Director, Alnylam Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2025

Primary Completion (Estimated)

December 29, 2026

Study Completion (Estimated)

March 23, 2027

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

December 10, 2025

First Posted (Actual)

December 22, 2025

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ALN-4285-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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