Recruiting NCT07535606
A Study to Evaluate ALN-4915 in Adult Healthy Volunteers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ALN-4915, Placebo.
- Who it may be relevant to
- Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of ALN-4915.
Interventions
- Drug ALN-4915
ALN-4915 will be administered subcutaneously (SC) - Drug Placebo
Placebo will be administered SC
Primary outcome measures
- Frequency of Adverse Events [Time frame: 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 outcome measures (3)
- Change from Baseline Inflammatory Markers in Plasma [Time frame: Baseline up to Month 9]
- Concentration of ALN-4915 in Plasma [Time frame: Predose up to Day 3]
- Concentration of ALN-4915 in Urine [Time frame: Predose up to Day 1]
Eligibility criteria
Inclusion criteria
- Is willing and able to complete all study assessments
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United Kingdom · 1 center
- Clinical Trial Site — London
Identifiers
NCT: NCT07535606 · ALN-4915-001