MedTrace Logo

A Phase 1 Study of EXT608 in Healthy Adults

NCT05408663 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-02-04

Study results available
· View outcomes & findings →

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.

Conditions

  • Safety Issues

Interventions

DRUG

EXT608

EXT608 is an investigational drug administered via subcutaneous injection

OTHER

Placebo

matching placebo administered via subcutaneous injection

Sponsors & Collaborators

  • Integrated Medical Development

    collaborator INDUSTRY

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Pharmaceutical Research Associates

    collaborator OTHER

  • Extend Biosciences Inc.

    lead INDUSTRY

Principal Investigators

  • Laura Hales, PhD · Extend Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-21
Primary Completion
2023-06-13
Completion
2023-06-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05408663 on ClinicalTrials.gov