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

Safety Issues Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04485481
Study type Interventional
Source Q32 Bio Inc.
Contact
Status Completed
Phase Phase 1
Start date September 8, 2020
Completion date January 12, 2022
View Details
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