A Study to Evaluate ALN-4915 in Adult Healthy Volunteers

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07535606

Enrollment

Registered

2026-04-17

Start date

2026-03-02

Completion date

2027-07-31

Last updated

2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

siRNA, RNAi

Brief summary

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

Interventions

DRUGALN-4915

ALN-4915 will be administered subcutaneously (SC)

DRUGPlacebo

Placebo will be administered SC

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United Kingdom

Contacts

CONTACTClinical Trial Information Line

clinicaltrials@alnylam.com1-877-ALNYLAM

STUDY_DIRECTORMedical Director

Alnylam Pharmaceuticals

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026