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

You have a chance of qualifying for this trial. We made sure your application will take less than 5 minutes.

Eligibility

18 - 65

All Sexes

What conditions do you have?

Select

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)

1

1

1

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)

1

1

1

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

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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 - 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.

References

2022. "A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CB03-154 in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05499260.

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