NCT07295717

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
11mo left

Started Dec 2025

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Dec 2025Mar 2027

First Submitted

Initial submission to the registry

December 10, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

December 12, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2027

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

December 10, 2025

Last Update Submit

April 16, 2026

Conditions

Healthy Volunteers

Keywords

siRNARNAi therapeutics

Outcome Measures

Primary Outcomes (1)

  • Frequency of Adverse Events (AEs)

    Up to Week 24

Secondary Outcomes (1)

  • Concentration of ALN-4285 in Plasma

    Up to Day 3

Study Arms (2)

ALN-4285

EXPERIMENTAL

Participants will be administered ALN-4285 subcutaneously (SC)

Drug: ALN-4285

Placebo

PLACEBO COMPARATOR

Participants will be administered placebo SC

Drug: Placebo

Interventions

ALN-4285DRUG

ALN-4285 will be administered SC

ALN-4285
PlaceboDRUG

Placebo will be administered SC

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Site

London, NW10 7EW, United Kingdom

RECRUITING

Study Officials

  • Medical Director

    Alnylam Pharmaceuticals Inc

    STUDY DIRECTOR

Central Study Contacts

Clinical Trial Information Line

CONTACT

1-877-ALNYLAMclinicaltrials@alnylam.com

Clinical Trial Information Line

CONTACT

1-877-256-9526clinicaltrials@alnylam.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2025

First Posted

December 22, 2025

Study Start

December 12, 2025

Primary Completion (Estimated)

December 29, 2026

Study Completion (Estimated)

March 23, 2027

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)