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Clinical Trials/NCT06675565
NCT06675565
Completed
Phase 1

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of ALN-AGT01 RVR in Adult Healthy Volunteers

Alnylam Pharmaceuticals1 site in 1 country42 target enrollmentNovember 5, 2024
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ConditionsHealthy Volunteers
InterventionsALN-AGT01 RVRPlacebo
DrugsALN-AGT01 RVRPlacebo

Overview

Phase
Phase 1
Intervention
ALN-AGT01 RVR
Conditions
Healthy Volunteers
Sponsor
Alnylam Pharmaceuticals
Enrollment
42
Locations
1
Primary Endpoint
Frequency of Adverse Events (AEs)
Status
Completed
Last Updated
7 months ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and PK of single ascending doses of ALN-AGT01 RVR.

Registry
clinicaltrials.gov
Start Date
November 5, 2024
End Date
September 8, 2025
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

ALN-AGT01 RVR

Participants will be administered a single dose of ALN-AGT01 RVR.

Intervention: ALN-AGT01 RVR

Placebo

Participants will be administered a single dose of placebo.

Intervention: Placebo

Outcomes

Primary Outcomes

Frequency of Adverse Events (AEs)

Time Frame: Up to 3 months

Secondary Outcomes

  • Area Under the Plasma Concentration-time Curve (AUC) of ALN-AGT01 RVR in Plasma(Predose and up to 3 days postdose)
  • Maximum Observed Plasma Concentration (Cmax) of ALN-AGT01 RVR in Plasma(Predose and up to 3 days postdose)
  • Time to Maximum Plasma Concentration (Tmax) of ALN-AGT01 RVR in Plasma(Predose and up to 3 days postdose)
  • Concentrations of ALN-AGT01 RVR in Urine(Predose and up to 1 day postdone)

Study Sites (1)

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