A Study to Evaluate ALN-4285 in Adult Healthy Volunteers
ConditionHealthy Volunteers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAlnylam Pharmaceuticals
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Has a body mass index (BMI) of ≥18.0 kg/m² and ≤30 kg/m²
Has 12-lead ECG within normal limits or with no clinically significant abnormalities in the opinion of the Investigator
Disqualifiers
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/1.73m² at screening
Trial design
Design model
Parallel
Treatments tested in this trial
ALN-4285
DrugALN-4285 will be administered SC
Placebo
DrugPlacebo will be administered SC
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: ALN-4285Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Frequency of Adverse Events (AEs)
Time frame
Up to Week 24Secondary outcomes
1
Concentration of ALN-4285 in Plasma
Time frame
Up to Day 3Sponsors and contacts
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Source ClinicalTrials.gov