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CB03-154 for Healthy Subjects

Phase 1
Waitlist Available
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

Summary

This trial is testing a new drug called CB03-154 to help people with epilepsy. The study aims to see if the drug is safe, how well patients can handle it, and how the body processes it. Researchers are also looking at whether taking the drug with food changes its effects.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To evaluate the safety and tolerability of CB03-154 following single and multiple ascending oral dose administration.
Secondary study objectives
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 MAD 10mgPlacebo Group1 Intervention
Participants will receive placebo 10mg orally once daily in a fasted state, for 14 consecutive days.
Group XI: Placebo SAD 60mgPlacebo Group1 Intervention
Participants will receive placebo 60mg orally once daily in a fasted state.
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

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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
7 Previous Clinical Trials
484 Total Patients Enrolled
Frank Lee, M.DPrincipal InvestigatorFrontage Clinical Services, Inc.
~20 spots leftby Nov 2025
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