Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT06675565
NCT06675565CompletedPhase 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 enrollmentStarted: November 5, 2024Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
42
Locations
1
Primary Endpoint
Frequency of Adverse Events (AEs)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

ALN-AGT01 RVR

Experimental

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

Intervention: ALN-AGT01 RVR (Drug)

Placebo

Placebo Comparator

Participants will be administered a single dose of placebo.

Intervention: Placebo (Drug)

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)

Investigators

Sponsor
Alnylam Pharmaceuticals
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Active, not recruiting
Phase 1
Safety, PK/PD, and Immunogenicity Study of SC ALXN2030 in Healthy ParticipantsHealthy
NCT05501717Alexion Pharmaceuticals, Inc.48
Completed
Phase 1
A Study to Test the Safety, Pharmacokinetics, and Efficacy of UCB9741 in Healthy Study Participants and in Study Participants With Atopic DermatitisAtopic Dermatitis
NCT04643457UCB Biopharma SRL107
Completed
Phase 1
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF10073 After Single and Multiple Doses in Healthy Volunteers and the Effect of Itraconazole on CHF10073 ExposurePulmonary Fibrosis
NCT06746064Chiesi Farmaceutici S.p.A.155
Completed
Phase 1
First in Man Clinical Trial of Emodepside (BAY 44-4400)Healthy Volunteers
NCT02661178Drugs for Neglected Diseases79
Completed
Phase 1
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB100 Administered Orally to Adults With Amyotrophic Lateral SclerosisAmyotrophic Lateral Sclerosis
NCT03945279Biogen49