CB03-154 for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Frontage Clinical Services, Inc., Secaucus, NJ
Healthy Subjects (HS)
CB03-154 - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

CB03-154 is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Epilepsy.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Healthy Subjects (HS)

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: From 1 hour pre-dose to 48 hours post-dose

Hour 48
Area Under the Plasma Concentration Versus Time Curve (AUC) of CB03-154
Maximum Plasma Concentration (Cmax) of CB03-154
Day 30
To evaluate the safety and tolerability of CB03-154 following single and multiple ascending oral dose administration.

Trial Safety

Safety Progress

1 of 3

Other trials for Healthy Subjects (HS)

Trial Design

17 Treatment Groups

CB03-154 FE
1 of 17
CB03-154 SAD 40mg
1 of 17
CB03-154 MAD 10mg
1 of 17
CB03-154 MAD 20mg
1 of 17
CB03-154 SAD 60mg
1 of 17
CB03-154 SAD 5mg
1 of 17
CB03-154 MAD 40mg
1 of 17
CB03-154 SAD 10mg
1 of 17
CB03-154 SAD 20mg
1 of 17
Placebo SAD 10mg
1 of 17
Placebo MAD 10mg
1 of 17
Placebo MAD 20mg
1 of 17
Placebo SAD 60mg
1 of 17
Placebo SAD 5mg
1 of 17
Placebo MAD 40mg
1 of 17
Placebo SAD 40mg
1 of 17
Placebo SAD 20mg
1 of 17
Experimental Treatment
Non-Treatment Group

70 Total Participants · 17 Treatment Groups

Primary Treatment: CB03-154 · Has Placebo Group · Phase 1

CB03-154 FE
Drug
Experimental Group · 1 Intervention: CB03-154 · Intervention Types: Drug
CB03-154 SAD 40mg
Drug
Experimental Group · 1 Intervention: CB03-154 · Intervention Types: Drug
CB03-154 MAD 10mg
Drug
Experimental Group · 1 Intervention: CB03-154 · Intervention Types: Drug
CB03-154 MAD 20mg
Drug
Experimental Group · 1 Intervention: CB03-154 · Intervention Types: Drug
CB03-154 SAD 60mg
Drug
Experimental Group · 1 Intervention: CB03-154 · Intervention Types: Drug
CB03-154 SAD 5mg
Drug
Experimental Group · 1 Intervention: CB03-154 · Intervention Types: Drug
CB03-154 MAD 40mg
Drug
Experimental Group · 1 Intervention: CB03-154 · Intervention Types: Drug
CB03-154 SAD 10mg
Drug
Experimental Group · 1 Intervention: CB03-154 · Intervention Types: Drug
CB03-154 SAD 20mg
Drug
Experimental Group · 1 Intervention: CB03-154 · Intervention Types: Drug
Placebo SAD 10mg
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Placebo MAD 10mg
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Placebo MAD 20mg
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Placebo SAD 60mg
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Placebo SAD 5mg
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Placebo MAD 40mg
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Placebo SAD 40mg
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Placebo SAD 20mg
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

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: from 1 hour pre-dose to 48 hours post-dose
Closest Location: Frontage Clinical Services, Inc. · Secaucus, NJ
Photo of new jersey 1Photo of new jersey 2Photo of new jersey 3
2018First Recorded Clinical Trial
5 TrialsResearching Healthy Subjects (HS)
6 CompletedClinical Trials

Who is running the clinical trial?

Shanghai Zhimeng Biopharma, Inc.Lead Sponsor
4 Previous Clinical Trials
266 Total Patients Enrolled
3 Trials studying Healthy Subjects (HS)
176 Patients Enrolled for Healthy Subjects (HS)
Frank Lee, M.DPrincipal InvestigatorFrontage Clinical Services, Inc.

Eligibility Criteria

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

Mark “yes” if the following statements are true for you:
You are able to understand and are willing to sign a written informed consent form.
You are willing and able to comply with study procedures and follow-up examination.
You are a male and you are sexually active with a female partner of child-bearing potential.

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.