NCT04485481

Single and Multiple Ascending Dose Study of ADX-914 in Healthy Adult Volunteers

A Double-Blind, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of ADX-914 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Q32 Bio Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

A two (2) part study to evaluate the safety, tolerability and PK of ADX-914

Detailed description

Part 1 - SAD: It is expected that there will be up to 6 cohorts of 8 participants per cohort. In each cohort, participants will be randomly assigned in a 3:1 ratio to receive either ADX-914 or matching placebo. It is planned that for each cohort in Part 1 a staggered 'sentinel' dose design will be used. Part 2 - MAD It is expected that there will be up to 3 cohorts of 8 participants per cohort. In each cohort, participants will be randomly assigned in a 3:1 ratio to receive either ADX-914 or matching placebo. Doses will occur every 2 weeks, for a total of 4 doses.

Conditions

• Safety Issues

Interventions

Type	Name	Description
DRUG	ADX-914	Single dose from 0.1mg/kg to TBD
DRUG	Placebo	Matching single dose placebo
DRUG	ADX-914	Multiple dose from TBD to TBD
DRUG	Placebo	Matching multiple dose placebo

Timeline

• Start date: 2020-09-08
• Primary completion: 2022-01-12
• Completion: 2022-01-12
• First posted: 2020-07-24
• Last updated: 2022-07-28

Locations

1 site across 1 country: Australia