A Study to Evaluate ALN-4285 in Adult Healthy Volunteers

Alnylam Pharmaceuticals

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: ALN-4285; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07295717

ALN-4285-001

Details and patient eligibility

About

The purpose of this study is to:

• evaluate the safety and tolerability of single ascending doses of ALN-4285 in healthy volunteers
• characterize the single-dose pharmacokinetics (PK) of ALN-4285

Enrollment: 76 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Has a body mass index (BMI) of ≥18.0 kg/m^2 and ≤30 kg/m^2
• Has 12-lead ECG within normal limits or with no clinically significant abnormalities in the opinion of the Investigator

Exclusion criteria

• Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >upper limit of normal (ULN)
• Has total bilirubin >ULN
• Has systolic blood pressure >140 mmHg and/or a diastolic blood pressure >90 mmHg
• Has an estimated glomerular filtration (eGFR) of <90 mL/min/1.73m^2 at screening
• Has received an investigational agent within the last 30 days or 5 half-lives

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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76 participants in 2 patient groups, including a placebo group

ALN-4285

Experimental group

Description:

Participants will be administered ALN-4285 subcutaneously (SC)

Treatment:

Drug: ALN-4285

Placebo

Placebo Comparator group

Description:

Participants will be administered placebo SC

Treatment:

Drug: Placebo