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Looking for participantsPhase1

A Study to Evaluate ALN-4285 in Adult Healthy Volunteers

Sponsor: Alnylam Pharmaceuticals

NCT ID: NCT07295717

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
ALN-4285 (drug), Placebo (drug)
How long the study runs
Study runs about 15 months (dates as stated)
About the drug or intervention
ALN-4285 — drug: ALN-4285 will be administered SC · Placebo — drug: Placebo will be administered SC
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 65 Years
Who
All
Number of participants
76
Started
2025-12-12
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for healthy volunteers
  • • Phase1 - 76 participants
  • • 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

Who can take part?

  • • Ages 18 Years to 65 Years
  • • Diagnosed with healthy volunteers

Where?

  • • London - Clinical Trial Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

Healthy Volunteers

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 65 Years
  • Who can join: All genders

Biomarkers mentioned

eGFR

What the study is looking for

  • ✓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

Who cannot take part

  • ✗Has alanine aminotransferase (liver enzymes) or aspartate aminotransferase (liver enzymes) \>upper limit of normal (ULN)
  • ✗Has total liver blood test \>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
See the full 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

Where Is This Study? (1 UK site)

Clinical Trial Site

London NW10 7EW, United Kingdom

Recruiting

How to Get in Touch

Clinical Trial Information Line

Sponsor contact

CONTACT

1-877-ALNYLAM clinicaltrials@alnylam.com

Clinical Trial Information Line

Sponsor contact

CONTACT

1-877-256-9526 clinicaltrials@alnylam.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09