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Unknown
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
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0 to day 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 to day 28
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 moreSecondary 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
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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
2,812 Previous Clinical Trials
8,161,447 Total Patients Enrolled
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