EXT608 for Safety Issues

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
PRA, Lenexa, KS
Safety Issues
EXT608 - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Safety Issues

Study Objectives

11 Primary · 3 Secondary · Reporting Duration: Day 0 to Day 28

Day 28
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
Safety and tolerability of EXT608 - Adverse events
Safety and tolerability of EXT608 - Physical exam
Safety and tolerability of EXT608- ECG PR interval
Safety and tolerability of EXT608- ECG QRS interval
Safety and tolerability of EXT608- ECG QT interval
Safety and tolerability of EXT608- ECG RR interval
Safety and tolerability of EXT608- injection site reactions
Safety and tolerability of EXT608-clinical laboratory assessments
Up to Day 3
Single dose PK- AUC
Single dose PK-Cmax
up to Day 3
Single dose PK - Tmax

Trial Safety

Safety Progress

1 of 3

Other trials for Safety Issues

Trial Design

2 Treatment Groups

Experimental- EXT608
1 of 2
Placebo comparator
1 of 2
Experimental Treatment
Non-Treatment Group

30 Total Participants · 2 Treatment Groups

Primary Treatment: EXT608 · Has Placebo Group · Phase 1

Experimental- EXT608
Drug
Experimental Group · 1 Intervention: EXT608 · Intervention Types: Drug
Placebo comparator
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 0 to day 28
Closest Location: PRA · Lenexa, KS
Photo of kansas 1Photo of kansas 2Photo of kansas 3
2011First Recorded Clinical Trial
1 TrialsResearching Safety Issues
14 CompletedClinical Trials

Who is running the clinical trial?

Integrated Medical DevelopmentIndustry Sponsor
6 Previous Clinical Trials
1,643 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,390 Previous Clinical Trials
24,521,527 Total Patients Enrolled
1 Trials studying Safety Issues
40 Patients Enrolled for Safety Issues
Pharmaceutical Research AssociatesOTHER
17 Previous Clinical Trials
13,136 Total Patients Enrolled
Extend Biosciences Inc.Lead Sponsor
Laura Hales, PhDStudy DirectorExtend Biosciences

Eligibility Criteria

Age 18 - 65 · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
PTH concentration within normal laboratory limits.
You are between the ages of 18 and 55 years.
You have a body mass index between 18.5 and 32 kilogram per square meter (kg/m2), inclusive, with a body weight greater than or equal to (>=) 45 kg.
Hemoglobin > 11.7 g/dl (females) or 13.1 g/dl (males) and < 16 g/dl (females) or 17.4 g/dl (males).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.