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EXT608 for Safety Concerns

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
Awards & highlights

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
1,818 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,765 Previous Clinical Trials
8,133,487 Total Patients Enrolled
~8 spots leftby Sep 2025
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