A Study to Evaluate ALN-4285 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-4285, 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-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered ALN-4285 in Adult Healthy Volunteers
Overview
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
Interventions
- Drug ALN-4285
ALN-4285 will be administered SC - Drug Placebo
Placebo will be administered SC
Primary outcome measures
- Frequency of Adverse Events (AEs) [Time frame: Up to Week 24]
Secondary outcome measures (1)
- Concentration of ALN-4285 in Plasma [Time frame: Up to Day 3]
Eligibility criteria
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
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: NCT07295717 · ALN-4285-001