Healthy VolunteersPhase 1NCT07535606
A Study to Evaluate ALN-4915 in Adult Healthy Volunteers
A Phase 1 study testing ALN-4915 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, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of ALN-4915. 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-4915
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Mar 2026to 31 Jul 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
- Is willing and able to complete all study assessments
Who cannot join
- Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >upper limit of normal (ULN)
- Has total bilirubin >ULN
- Has no history of invasive infection by an encapsulated organism
- Has no known complement or immunologic deficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Masked, Placebo-controlled, Single Ascending Dose Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALN-4915 in Adult Healthy Volunteers
The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of ALN-4915.
- Conditions
- Healthy Volunteers
- Being tested
- ALN-4915, Placebo
- Keywords
- siRNA, RNAi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALN-4915Drug
ALN-4915 will be administered subcutaneously (SC)
PlaceboDrug
Placebo will be administered SC
| Study group | Role | What they receive |
|---|---|---|
| ALN-4915 | Experimental | Participants will be administered a single dose of ALN-4195. Receives: Drug: ALN-4915 |
| Placebo | Placebo comparator | Participants will be administered a single dose of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events
Measured: Serious adverse events (SAEs) after signing of ICF up to Month 12; nonserious AEs after first dose of study drug up to Month 12
Secondary outcomes (3)
Change from Baseline Inflammatory Markers in Plasma
Measured: Baseline up to Month 9
Concentration of ALN-4915 in Plasma
Measured: Predose up to Day 3
Concentration of ALN-4915 in Urine
Measured: Predose up to Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start2 Mar 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 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
- 36 participants (actual)
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
- NCT07535606
- Sponsor's protocol ID
- ALN-4915-001
- Status last verified
- Oct 2026
- First submitted
- 26 Feb 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No