NCT06675565

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Nov 2024

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 5, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

November 5, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2025

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

October 29, 2024

Last Update Submit

September 17, 2025

Conditions

Healthy Volunteers

Keywords

RNAi therapeutic

Outcome Measures

Primary Outcomes (1)

  • Frequency of Adverse Events (AEs)

    Up to 3 months

Secondary Outcomes (4)

  • 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 Arms (2)

ALN-AGT01 RVR

EXPERIMENTAL

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

Drug: ALN-AGT01 RVR

Placebo

PLACEBO COMPARATOR

Participants will be administered a single dose of placebo.

Drug: Placebo

Interventions

ALN-AGT01 RVRDRUG

ALN-AGT01 RVR will be administered subcutaneously (SC)

ALN-AGT01 RVR
PlaceboDRUG

Placebo will be administered SC

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Is an adult healthy volunteer
  • Has a body mass index ≥18 kg/m\^2 and ≤28 kg/m\^2

You may not qualify if:

  • Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> upper limit of normal (ULN)
  • Has known human immunodeficiency virus infection; or known current or chronic hepatitis C virus or hepatitis B virus infection
  • Has an estimated glomerular filtration rate (eGFR) of \<90 mL/min/1.73m\^2 at screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Site

Montreal, Canada

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2024

First Posted

November 5, 2024

Study Start

November 5, 2024

Primary Completion

September 8, 2025

Study Completion

September 8, 2025

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)