NCT05408663

A Phase 1 Study of EXT608 in Healthy Adults

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Extend Biosciences Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a randomized, double-blind, first-in-human, placebo-controlled single ascending dose study to study the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (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 Adverse Events (AEs) at the discretion of the Investigator

Conditions

• Safety Issues

Interventions

Type	Name	Description
DRUG	EXT608	EXT608 is an investigational drug administered via subcutaneous injection
OTHER	Placebo	matching placebo administered via subcutaneous injection

Timeline

• Start date: 2022-07-21
• Primary completion: 2023-06-13
• Completion: 2023-06-13
• First posted: 2022-06-07
• Last updated: 2025-02-04
• Results posted: 2025-02-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study