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CB03-154 for Healthy Subjects

Phase 1
Recruiting
Led By Frank Lee, M.D
Research Sponsored by Shanghai Zhimeng Biopharma, 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 from 1 hour pre-dose to 48 hours post-dose
Awards & highlights

Study Summary

This trial tests the safety and efficacy of CB03-154 in the treatment of Epilepsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 1 hour pre-dose to 48 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 1 hour pre-dose to 48 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To evaluate the safety and tolerability of CB03-154 following single and multiple ascending oral dose administration.
Secondary outcome measures
Area Under the Plasma Concentration Versus Time Curve (AUC) of CB03-154
Maximum Plasma Concentration (Cmax) of CB03-154

Trial Design

17Treatment groups
Experimental Treatment
Placebo Group
Group I: CB03-154 SAD 60mgExperimental Treatment1 Intervention
Participants will receive CB03-154 60mg orally once daily in a fasted state.
Group II: CB03-154 SAD 5mgExperimental Treatment1 Intervention
Participants will receive CB03-154 5mg orally once daily in a fasted state.
Group III: CB03-154 SAD 40mgExperimental Treatment1 Intervention
Participants will receive CB03-154 40mg orally once daily in a fasted state.
Group IV: CB03-154 SAD 20mgExperimental Treatment1 Intervention
Participants will receive CB03-154 20mg orally once daily in a fasted state.
Group V: CB03-154 SAD 10mgExperimental Treatment1 Intervention
Participants will receive CB03-154 10mg orally once daily in a fasted state.
Group VI: CB03-154 MAD 40mgExperimental Treatment1 Intervention
Participants will receive CB03-154 40mg orally once daily in a fasted state, for 14 consecutive days.
Group VII: CB03-154 MAD 20mgExperimental Treatment1 Intervention
Participants will receive CB03-154 20mg orally once daily in a fasted state, for 14 consecutive days.
Group VIII: CB03-154 MAD 10mgExperimental Treatment1 Intervention
Participants will receive CB03-154 10mg orally once daily in a fasted state, for 14 consecutive days.
Group IX: CB03-154 FEExperimental Treatment1 Intervention
Participants will receive CB03-154 orally once daily in a fed state.
Group X: Placebo SAD 60mgPlacebo Group1 Intervention
Participants will receive placebo 60mg orally once daily in a fasted state.
Group XI: Placebo MAD 10mgPlacebo Group1 Intervention
Participants will receive placebo 10mg orally once daily in a fasted state, for 14 consecutive days.
Group XII: Placebo MAD 40mgPlacebo Group1 Intervention
Participants will receive placebo 40mg orally once daily in a fasted state, for 14 consecutive days.
Group XIII: Placebo SAD 5mgPlacebo Group1 Intervention
Participants will receive placebo 5mg orally once daily in a fasted state.
Group XIV: Placebo SAD 10mgPlacebo Group1 Intervention
Participants will receive placebo 10mg orally once daily in a fasted state.
Group XV: Placebo SAD 20mgPlacebo Group1 Intervention
Participants will receive placebo 20mg orally once daily in a fasted state.
Group XVI: Placebo SAD 40mgPlacebo Group1 Intervention
Participants will receive placebo 40mg orally once daily in a fasted state
Group XVII: Placebo MAD 20mgPlacebo Group1 Intervention
Participants will receive placebo 20mg orally once daily in a fasted state, for 14 consecutive days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CB03-154
2022
Completed Phase 1
~60

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Shanghai Zhimeng Biopharma, Inc.Lead Sponsor
6 Previous Clinical Trials
304 Total Patients Enrolled
Frank Lee, M.DPrincipal InvestigatorFrontage Clinical Services, Inc.

Frequently Asked Questions

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

To what extent could CB03-154 harm patients?

"Considering the limited clinical data available, our team assessed CB03-154 as having a safety rating of 1. This reflects its status as being in phase one testing."

Answered by AI

What is the aggregate patient count of this experiment?

"Yes, information hosted on clinicaltrials.gov affirms that this investigation is at present enrolling individuals. This trial was originally published on May 2nd 2022 and has been most recently updated in August 14th 2022. Aimed to involve 70 patients from a single site."

Answered by AI

Who meets the criteria to participate in this research?

"Potential participants must demonstrate healthy subjects (hs) and be between 18-55 years old to qualify for this clinical trial. Approximately 70 individuals are required for the study."

Answered by AI

Are participants aged 20 or older eligible for enrollment in this experiment?

"This medical study is only open to participants between the age of 18 and 55. Separately, there are 50 clinical trials for minors and 372 for seniors."

Answered by AI

Is this research currently open to volunteers?

"Affirmative. Information found on clinicaltrials.gov demonstrates that this investigation, which was initially posted on May 2nd 2022, is actively recruiting volunteers. 70 participants need to be sourced from a single research facility."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
New Jersey
How old are they?
18 - 65
What site did they apply to?
Frontage Clinical Services, Inc.
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CB03-154 in Healthy Participants
2022. "A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CB03-154 in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05499260.
~24 spots leftby Apr 2025
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