A Study to Evaluate ALN-AGT01 RVR in Adult Healthy Volunteers

Alnylam Pharmaceuticals

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: ALN-AGT01 RVR; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06675565

ALN-AGT01 RVR-001

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability and PK of single ascending doses of ALN-AGT01 RVR.

Enrollment: 78 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Is an adult healthy volunteer
• Has a body mass index ≥18 kg/m^2 and ≤28 kg/m^2

Exclusion Criteria

• Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > upper limit of normal (ULN)
• Has known human immunodeficiency virus infection; or known current or chronic hepatitis C virus or hepatitis B virus infection
• Has an estimated glomerular filtration rate (eGFR) of <90 mL/min/1.73m^2 at screening

Note: other protocol defined inclusion / exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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78 participants in 2 patient groups, including a placebo group

ALN-AGT01 RVR

Experimental group

Description:

Participants will be administered a single dose of ALN-AGT01 RVR.

Treatment:

Drug: ALN-AGT01 RVR

Placebo

Placebo Comparator group

Description:

Participants will be administered a single dose of placebo.

Treatment:

Drug: Placebo