A Study to Evaluate ALN-4915 in Adult Healthy Volunteers

May 12, 2026 updated by: Alnylam Pharmaceuticals

A Phase 1, Randomized, Double-Masked, Placebo-controlled, Single Ascending Dose Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALN-4915 in Adult Healthy Volunteers

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

44

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:

  • Is willing and able to complete all study assessments

Exclusion Criteria:

  • 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

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
Placebo Comparator: Placebo
Participants will be administered a single dose of placebo.
Drug: Placebo
Placebo will be administered SC
Experimental: ALN-4915
Participants will be administered a single dose of ALN-4195.
Drug: ALN-4915
ALN-4915 will be administered subcutaneously (SC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of Adverse Events
Time Frame: Serious adverse events (SAEs) after signing of ICF up to Month 12; nonserious AEs after first dose of study drug up to Month 12
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 Outcome Measures

Outcome Measure
Time Frame
Change from Baseline Inflammatory Markers in Plasma
Time Frame: Baseline up to Month 9
Baseline up to Month 9
Concentration of ALN-4915 in Plasma
Time Frame: Predose up to Day 3
Predose up to Day 3
Concentration of ALN-4915 in Urine
Time Frame: Predose up to Day 1
Predose up to Day 1

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)

March 2, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 17, 2026

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-4915-001

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

product manufactured in and exported from the U.S.

Yes

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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