A Study to Evaluate ALN-4915 in Adult Healthy Volunteers
Research type
Research Study
Full title
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
IRAS ID
1013136
Contact name
Andrew Slugg
Contact email
Sponsor organisation
Alnylam Pharmaceuticals, Inc.
Clinicaltrials.gov Identifier
Research summary
ALN-4915 (the trial medicine) is an experimental treatment for treating age-related macular degeneration (AMD). We hope the trial medicine will work by stopping the liver from making proteins called Factor H-related proteins (FHR) 1, 2, and 5, which help control a part of the immune system known as the complement system. This system helps protect the body from infections, but if it’s not regulated properly, it can cause damage to healthy tissues, including the eye. In people with age-related macular degeneration, the proper balance between FHR proteins and a protective protein called Factor H (H) may be disrupted. This imbalance can lead to inflammation and damage within the eye that may result in vision loss.
We aim to find out the trial medicine’s side effects, how much ALN-4915 gets into the bloodstream, and how does the body gets rid of it. We also want to find out how it affects the levels of FHR proteins in the body and how the immune system reacts to ALN-4915.
We’ll give up to 44 healthy participants (1 group of 4 participants and up to 5 groups of up to 12 participants), aged 18-65 years, a single dose of ALN-4915 as an injection under the skin. It’s never been given to humans before, so we’ll start with a low dose, and increase it as the trial progresses.
Participants will take up to 11 months to finish the study. They’ll make up to 8 outpatient visits and stay on the ward for 4 nights in a row.
A pharmaceutical company, Alnylam Pharmaceuticals, Inc., is funding the trial.
The trial will take place at 1 centre in London.
REC name
HSC REC B
REC reference
26/NI/0001
Date of REC Opinion
17 Feb 2026
REC opinion
Further Information Favourable Opinion