Health TrialsbyHealthPanel

A Study to Evaluate ALN-4915 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, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of ALN-4915.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Is willing and able to complete all study assessments

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • ALN-4915

    Drug

    ALN-4915 will be administered subcutaneously (SC)

  • Placebo

    Drug

    Placebo will be administered SC

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: ALN-4915Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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 outcomes

1

Change from Baseline Inflammatory Markers in Plasma

Time frame
Baseline up to Month 9
2

Concentration of ALN-4915 in Plasma

Time frame
Predose up to Day 3
3

Concentration of ALN-4915 in Urine

Time frame
Predose up to Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alnylam Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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