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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

Study Summary

This trial is testing a new drug, EXT608, to see if it is safe and tolerated in healthy subjects. There will be 6 groups of 4 people, 3 of whom will receive the drug and 1 of whom will receive a placebo.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
2,695 Previous Clinical Trials
6,952,547 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who qualifies to take part in this medical experiment?

"This clinical trial is searching for 30 individuals between 18 and 55 years of age who are in generally good medical health. More specifically, the desired participants should have a body mass index (BMI) between 18.5-32 kg/m2 with at least 45kg weight, hemoglobin values within 11.7-16 g/dl(females)/13.1-17.4g/dl(males), serum parathyroid hormone concentration within normal laboratory limits, and total Se-Ca also within laboratory established ranges. These criteria must be met to be eligible for consideration in this study."

Answered by AI

To what capacity is this research project recruiting participants?

"Affirmative. According to the details available on clinicaltrials.gov, this medical trial is currently accepting participants who meet its criteria - it was initially posted on July 11th 2022 and last updated then as well. The research aims to recruit 30 patients from a single site."

Answered by AI

Is this experiment open to elderly participants?

"Applicants aged between 18 and 55 are eligible to participate in this trial. There are also 3 studies available for minors, while 24 have been specifically designed for seniors over 65 years of age."

Answered by AI

What are the security implications of EXT608 use?

"The risk-benefit analysis conducted by the Power team resulted in EXT608 receiving a score of 1 due to its status as a Phase I trial, which suggests limited data exists on both efficacy and safety."

Answered by AI

Is there currently any availability for study participation?

"Yes, according to information hosted on clinicaltrials.gov this trial is actively soliciting potential participants. The initial posting was made July 11th of 2022 and has been maintained as recently as the same date - 30 volunteers are sought from one trial site."

Answered by AI

Who else is applying?

What state do they live in?
Kansas
How old are they?
18 - 65
What site did they apply to?
PRA
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Phase 1 Study of EXT608 in Healthy Adults
2022. "A Phase 1 Study of EXT608 in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05408663.
~9 spots leftby Apr 2025
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