ClinicalTrials.gg
RecruitingNCT07295717Updated Oct 20, 2026

A Study to Evaluate ALN-4285 in Adult Healthy Volunteers

A Phase 1 interventional study of ALN-4285 and Placebo in Healthy Volunteers, sponsored by Alnylam Pharmaceuticals. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Alnylam Pharmaceuticals · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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
02

Conditions studied

  • Healthy Volunteers

Keywords

  • siRNA
  • RNAi therapeutics
03

In context

Lead sponsor

Alnylam Pharmaceuticals is the lead sponsor of 84 studies on the registry; 19 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 15 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Has (ALT) or aspartate aminotransferase (AST) > (ULN)
  • Has total >ULN
  • Has systolic blood pressure >140 mmHg and/or a diastolic blood pressure >90 mmHg
  • Has an estimated glomerular filtration () of \<90 mL/min/1.73m\^2 at screening
  • Has received an agent within the last 30 days or 5 half-lives
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
76 participants (estimated)

Study arms

  • Experimental
    ALN-4285

    Participants will be administered ALN-4285 subcutaneously (SC)

    Drug: ALN-4285

  • Placebo comparator
    Placebo

    Participants will be administered placebo SC

    Drug: Placebo

Interventions

  • DrugALN-4285

    ALN-4285 will be administered SC

  • DrugPlacebo

    Placebo will be administered SC

06

What researchers measure

Primary outcomes

  1. Frequency of Adverse Events (AEs)

    Time frame: Up to Week 24

Secondary outcomes

  1. Concentration of ALN-4285 in Plasma

    Time frame: Up to Day 3

07

Study locations

1 of 1 sites recruiting
  • Clinical Trial Site
    London, NW10 7EW, United Kingdom
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2025 (actual). Primary completion is estimated for Dec 2026, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 10, 2025
First posted
Dec 22, 2025
StartActual
Dec 12, 2025
Primary completionEst.
Dec 29, 2026
CompletionEst.
Mar 23, 2027
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07295717
Responsible party
Sponsor
First posted
Dec 22, 2025
Start date
Dec 12, 2025
Primary completion
Dec 29, 2026 (estimated)
Completion
Mar 23, 2027 (estimated)
Last update
Oct 20, 2026

Study contacts

Clinical Trial Information Line
Contact
clinicaltrials@alnylam.com
1-877-ALNYLAM
Clinical Trial Information Line
Contact
clinicaltrials@alnylam.com
1-877-256-9526
Medical Director
study director · Alnylam Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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