A Phase 1 Study of EXT608 in Healthy Adults

Safety Issues Clinical Trial

Official title: EXT608 in Human Healthy Adults; A First-in-Human, Randomized, Double-Blind, Placebo-controlled, Single Dose Escalation Study

Status Completed

Clinical Trial Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose safety and tolerability study of EXT608 in healthy subjects. There will be up to 6 sequential dose escalation cohorts of 4 participants. In each cohort 3 participants will receive EXT608 and 1 participant will receive placebo.

Clinical Trial Description

This is a randomized, double-blind, first-in-human, placebo-controlled single ascending dose study to study the safety, tolerability, PK, and PD of EXT608 in healthy adult participants.

Participants will be enrolled into 1 of up to 6 planned single dose cohorts in ascending fashion.

Each cohort will consist of 4 participants randomized to receive either EXT608 or placebo, whereby 3 will receive a single injection of EXT608 and 1 will receive matching placebo.

Up to 6 dosing cohorts are planned with no single dose escalation to exceed a 3-fold dose increment. A Data Monitoring Board will review the seven-day safety data in each cohort before authorizing the initiation of the next cohort.

A screening visit will take place within 28 days of dosing. Eligible participants for each cohort will be admitted to the Clinical Research Unit (CRU) 1 day prior to dosing and remain in the CRU through at least 72 hours after dosing for safety and PK assessments before discharge. The total confinement period will be 4 nights, unless extended for management of AEs at the discretion of the Investigator ;

Related Conditions & MeSH terms

• Safety Issues

• NCT number: NCT05408663
• Study type: Interventional
• Source: Extend Biosciences Inc.
• Status: Completed
• Phase: Phase 1
• Start date: July 21, 2022
• Completion date: June 13, 2023