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A Phase 1 Study of EXT608 in Healthy Adults

Phase 1
Waitlist Available
Research Sponsored by Extend Biosciences Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 to day 28

Summary

This trial tests a new drug called EXT608 in healthy adults to see if it is safe and well-tolerated. Researchers want to understand how the body handles the drug and what effects it has.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 to day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 to day 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with participants with treatment-related adverse events as assessed by CTCAE v4.0 - Blood pressure
Number of participants with participants with treatment-related adverse events as assessed by CTCAE v4.0 - Pulse rate
Number of participants with participants with treatment-related adverse events as assessed by CTCAE v4.0 - Respiratory rate
+8 more
Secondary study objectives
Single dose PK - Tmax
Single dose PK- AUC
Single dose PK-Cmax

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental- EXT608Experimental Treatment1 Intervention
Up to 6 sequential dose escalation cohorts will receive a single dose of EXT608 administered as a subcutaneous injection
Group II: Placebo comparatorPlacebo Group1 Intervention
Up to 6 participants will receive matching placebo administered as a subcutaneous injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EXT608
2022
Completed Phase 1
~30

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Extend Biosciences Inc.Lead Sponsor
Integrated Medical DevelopmentIndustry Sponsor
7 Previous Clinical Trials
1,802 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,840 Previous Clinical Trials
8,172,596 Total Patients Enrolled
Pharmaceutical Research AssociatesOTHER
17 Previous Clinical Trials
13,040 Total Patients Enrolled
Laura Hales, PhDStudy DirectorExtend Biosciences
~7 spots leftby Dec 2025
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