A Study to Evaluate ALN-4285 in Adult Healthy Volunteers

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered ALN-4285 in Adult Healthy Volunteers

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07295717

Enrollment

Registered

2025-12-22

Start date

2025-12-12

Completion date

2027-03-23

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 therapeutics

Brief summary

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

Interventions

DRUGALN-4285

ALN-4285 will be administered 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

* 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

Design outcomes

Primary

Measure	Time frame
Frequency of Adverse Events (AEs)	Up to Week 24

Secondary

Measure	Time frame
Concentration of ALN-4285 in Plasma	Up to Day 3

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