Healthy VolunteersPhase 1NCT07295717
A Study to Evaluate ALN-4285 in Adult Healthy Volunteers
A Phase 1 study testing ALN-4285 in people with Healthy Volunteers, run by Alnylam Pharmaceuticals at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ALN-4285
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Dec 2025to 23 Mar 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Clinical Trial Site
London, NW10 7EW
About this study
Official title: 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
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
- Conditions
- Healthy Volunteers
- Being tested
- ALN-4285, Placebo
- Keywords
- siRNA, RNAi therapeutics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALN-4285Drug
ALN-4285 will be administered SC
PlaceboDrug
Placebo will be administered SC
| Study group | Role | What they receive |
|---|---|---|
| ALN-4285 | Experimental | Participants will be administered ALN-4285 subcutaneously (SC) Receives: Drug: ALN-4285 |
| Placebo | Placebo comparator | Participants will be administered placebo SC Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events (AEs)
Measured: Up to Week 24
Secondary outcomes (1)
Concentration of ALN-4285 in Plasma
Measured: Up to Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start12 Dec 2025
- Primary completion29 Dec 2026 (estimated)
- Study completion23 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Alnylam PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alnylam Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Alnylam Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295717
- Sponsor's protocol ID
- ALN-4285-001
- Status last verified
- Oct 2026
- First submitted
- 10 Dec 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No