A Study to Evaluate ALN-4915 in Adult Healthy Volunteers

Alnylam Pharmaceuticals

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: ALN-4915

Study type: Interventional

Funder types: Industry

Identifiers

NCT07535606

ALN-4915-001

Details and patient eligibility

About

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

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 2 patient groups, including a placebo group

ALN-4915

Experimental group

Description:

Participants will be administered a single dose of ALN-4195.

Treatment:

Drug: ALN-4915

Placebo

Placebo Comparator group

Description:

Participants will be administered a single dose of placebo.

Treatment:

Drug: Placebo