A Study to Evaluate ALN-AGT01 RVR in Adult Healthy Volunteers

Phase 1

Recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: Placebo; Drug: ALN-AGT01 RVR

• Registration Number: NCT06675565
• Lead Sponsor: Alnylam Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-29
• Study First Submitted QC: 2024-11-04
• Study Start: 2024-11-05
• Study First Posted: 2024-11-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-14
• Primary Completion: 2025-09-08
• Study Completion: 2025-09-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will be administered a single dose of placebo.
ALN-AGT01 RVR	ALN-AGT01 RVR	Participants will be administered a single dose of ALN-AGT01 RVR.

Primary Outcome Measures

Name	Time	Method
Frequency of Adverse Events (AEs)	Up to 3 months

Secondary Outcome Measures

Name	Time	Method
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	Fraction of ALN-AGT01 RVR excreted in urine

Trial Locations

Locations (1)

Clinical Trial Site; 🇨🇦 Montreal, Canada