ALN-4285 single ascending doses in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, randomized, placebo-controlled study enrolls healthy adult volunteers to receive single ascending doses of ALN-4285 or placebo. The trial's primary objectives are to characterize safety, tolerability, and single-dose pharmacokinetics. Participants must meet criteria for BMI, ECG, liver and kidney function, and blood pressure and must not have recent exposure to other investigational agents. The study is sponsored by Alnylam Pharmaceuticals and conducted at a clinical site in London.

Why it matters

Who can join: the full rules

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 it's running

• Clinical Trial Site
  London, United Kingdom Recruiting

Study contacts

• Study coordinator: Clinical Trial Information Line
• Email: clinicaltrials@alnylam.com
• Phone: 1-877-ALNYLAM

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Mivelsiran for early Down syndrome–associated Alzheimer's disease in adults

  A 2-phase study will test whether mivelsiran can help adults with early DS-AD and see how safe and how it behaves in the body.

  Recruiting at 10 sites Phase 2 Alnylam Pharmaceuticals · Maitland, Florida and 9 other locations · NCT07636811

• First-in-human test of ALN-6222 in adults with obesity

  A first-in-human, randomized, placebo-controlled study will test a subcutaneous injection of ALN-6222 in adults with obesity to see if it is safe, tolerated, and how the body processes and responds to it.

  Recruiting Phase 1 Alnylam Pharmaceuticals · Mount Royal · NCT07624071

• ALN-6400 for women with von Willebrand disease and heavy menstrual bleeding

  This study tests ALN-6400 to see if it can help reduce heavy menstrual bleeding in adult and adolescent women with von Willebrand disease.

  Recruiting Phase 2 Alnylam Pharmaceuticals · Orange, California and 20 other locations · NCT07575308

• A person-friendly look at ALN-AGT01 RVR in adults with mild to moderate high blood pressure who had prior zilebesiran

  This study tests whether ALN-AGT01 RVR can help adults with mild to moderate hypertension who previously used zilebesiran.

  Recruiting Phase 2 Alnylam Pharmaceuticals · Lake Forest, California and 2 other locations · NCT07553442

• ALN-4324 for insulin sensitivity in adults with type 2 diabetes

  This study will test whether a single dose of ALN-4324 improves whole-body insulin sensitivity in adults with type 2 diabetes who are on stable metformin therapy.

  Recruiting Phase 2 Alnylam Pharmaceuticals · Chula Vista, California · NCT07465224

• ALN-2232 treatment for people with obesity.

  This trial will test whether ALN-2232, alone or started with tirzepatide, is safe, well tolerated, and helps people with obesity (BMI 30–<40 and HbA1c <6.5%) lose weight while measuring how the drug behaves in the body.

  Recruiting Phase 1/2 Alnylam Pharmaceuticals · Mount Royal · NCT07463846

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.