A Study to Evaluate ALN-4285 in Adult Healthy Volunteers | NCT07295717

Studies
A Study to Evaluate ALN-4285 in Adult Healthy Volunteers

NCT07295717

Sponsor

Alnylam Pharmaceuticals

Status

Recruiting

Last Update Posted

Jun 12, 2026Actual

Enrollment

76Estimated

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

ALN-4285
Placebo

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 12, 2025Actual

Primary Completion Date

Dec 29, 2026Estimated

Completion Date

Mar 23, 2027Estimated

First Submitted Date

Dec 10, 2025

First Submission Date that Met QC Criteria

Dec 10, 2025

First Posted Date

Dec 22, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2026

Last Update Posted Date

Jun 12, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

76Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ALN-4285	Experimental	Participants will be administered ALN-4285 subcutaneously (SC)	Drug: ALN-4285
Placebo	Placebo Comparator	Participants will be administered placebo SC	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ALN-4285	Drug	ALN-4285 will be administered SC	ALN-4285
Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Clinical Trial Information Line	Contact	1-877-ALNYLAM		clinicaltrials@alnylam.com
Clinical Trial Information Line	Contact	1-877-256-9526		clinicaltrials@alnylam.com

Overall Officials

Name	Affiliation	Role
Medical Director	Alnylam Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Trial Site	Recruiting	London		NW10 7EW	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided