Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07535606

A Study to Evaluate 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Site

London, NW10 7EW, United Kingdom

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALN-4915

Drug

ALN-4915 will be administered subcutaneously (SC)

Placebo

Drug

Placebo will be administered SC

Primary outcomes

  1. 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

Secondary outcomes

  1. Change from Baseline Inflammatory Markers in Plasma

    Time frame: Baseline up to Month 9

  2. Concentration of ALN-4915 in Plasma

    Time frame: Predose up to Day 3

  3. Concentration of ALN-4915 in Urine

    Time frame: Predose up to Day 1

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trial Information Line

CONTACT

[email protected]

1-877-ALNYLAM

Clinical Trial Information Line

CONTACT

[email protected]

1-877-256-9526

Sponsors and collaborators

Lead sponsor

Alnylam Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 17, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.