Part A: Healthy Volunteers: Single ascending doses for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Medpace Clinical Pharmacology Unit, Cincinnati, OH
Healthy Subjects (HS)
CHK336 - Drug
Eligibility
18 - 65
All Sexes
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Study Summary

This study is designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamic effects of an investigational drug (CHK-336) when administered to healthy volunteers.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Healthy Subjects (HS)

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Up to 28 days

Up to 17 days
Pharmacokinetic measure of AUC (0-∞)
Pharmacokinetic measure of Cmax
Pharmacokinetic measure of Tmax
Up to 24 hours
Pharmacokinetic measure of the amount of CHK-336 excreted in urine
Up to 28 days
To evaluate the safety and tolerability of single ascending doses and multiple ascending doses of CHK-336 in HV
up to 17 days
Pharmacokinetic measure of AUC for up to 24 hours (AUC0-24)
Pharmacokinetic measure of AUC for up to last measurable time point (AUC0-T)
Pharmacokinetic measure of apparent terminal half-life (t1/2)
Pharmacokinetic measure of exposure accumulation ratios (Cmax) for CHK-336
Pharmacokinetic measure of exposure accumulation ratios of CHK-336

Trial Safety

Safety Progress

1 of 3

Other trials for Healthy Subjects (HS)

Trial Design

4 Treatment Groups

Part A: Healthy Volunteers: Single ascending doses
1 of 4
Part B: Healthy Volunteers: Multiple Ascending doses
1 of 4
Part A: Healthy Volunteer: Single Ascending dose under fed condition
1 of 4
A8 option cohort- Healthy volunteer Single Ascending dose
1 of 4
Experimental Treatment

104 Total Participants · 4 Treatment Groups

Primary Treatment: Part A: Healthy Volunteers: Single ascending doses · Has Placebo Group · Phase 1

Part A: Healthy Volunteers: Single ascending dosesExperimental Group · 2 Interventions: CHK336, Placebo · Intervention Types: Drug, Drug
Part B: Healthy Volunteers: Multiple Ascending dosesExperimental Group · 2 Interventions: CHK336, Placebo · Intervention Types: Drug, Drug
Part A: Healthy Volunteer: Single Ascending dose under fed condition
Drug
Experimental Group · 1 Intervention: CHK336 · Intervention Types: Drug
A8 option cohort- Healthy volunteer Single Ascending doseExperimental Group · 2 Interventions: CHK336, Placebo · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

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: up to 28 days
Closest Location: Medpace Clinical Pharmacology Unit · Cincinnati, OH
Photo of Cincinnati  1Photo of Cincinnati  2Photo of Cincinnati  3
2009First Recorded Clinical Trial
9 TrialsResearching Healthy Subjects (HS)
26 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are between 19 and 32 kg/m2, inclusive, at screening.
You are of childbearing potential (WOCBP) and have a negative serum pregnancy test at screening and Day -3 as well as a negative urine pregnancy test at Day 1 (predose).
You are willing and able to comply with a pre-specified diet at least 72 hours prior to dose and throughout the study.
You are willing and able to provide informed consent and comply with all study visits and procedures including overnight stays in the clinic.
You are willing to be treated with the study drug and to be followed up for a period of at least 3 months.

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.