NCT07535606

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of ALN-4915.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
15mo left

Started Mar 2026

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 Progress13%
Mar 2026Jul 2027

First Submitted

Initial submission to the registry

February 26, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

March 2, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

February 26, 2026

Last Update Submit

April 10, 2026

Conditions

Healthy Volunteers

Keywords

siRNARNAi

Outcome Measures

Primary Outcomes (1)

  • Frequency of Adverse Events

    Serious adverse events (SAEs) after signing of ICF up to Month 12; nonserious AEs after first dose of study drug up to Month 12

Secondary Outcomes (3)

  • Change from Baseline Inflammatory Markers in Plasma

    Baseline up to Month 9

  • Concentration of ALN-4915 in Plasma

    Predose up to Day 3

  • Concentration of ALN-4915 in Urine

    Predose up to Day 1

Study Arms (2)

ALN-4915

EXPERIMENTAL

Participants will be administered a single dose of ALN-4195.

Drug: ALN-4915

Placebo

PLACEBO COMPARATOR

Participants will be administered a single dose of placebo.

Drug: Placebo

Interventions

PlaceboDRUG

Placebo will be administered SC

Placebo
ALN-4915DRUG

ALN-4915 will be administered subcutaneously (SC)

ALN-4915

Eligibility Criteria

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

You may qualify if:

  • Is willing and able to complete all study assessments

You may not qualify if:

  • Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>upper limit of normal (ULN)
  • Has total bilirubin \>ULN
  • Has no history of invasive infection by an encapsulated organism
  • Has no known complement or immunologic deficiency

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

February 26, 2026

First Posted

April 17, 2026

Study Start

March 2, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)