A Study to Evaluate ALN-4915 in Adult Healthy Volunteers

Phase 1RecruitingNCT07535606

Alnylam Pharmaceuticals44 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Healthy Volunteers

Interventions

ALN-4915DRUG

ALN-4915 will be administered subcutaneously (SC)

PlaceboDRUG

Placebo will be administered SC

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Clinical Trial Site

London, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

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

Change from Baseline Inflammatory Markers in Plasma

Time frame: Baseline up to Month 9

Concentration of ALN-4915 in Plasma

Time frame: Predose up to Day 3

Concentration of ALN-4915 in Urine

Time frame: Predose up to Day 1

Central Contacts

Clinical Trial Information Line

CONTACT

1-877-ALNYLAM clinicaltrials@alnylam.com

Clinical Trial Information Line

CONTACT

1-877-256-9526 clinicaltrials@alnylam.com

Data from ClinicalTrials.gov

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