A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CB03-154 in Healthy Participants

Overseen By Annie Li, M.D

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Shanghai Zhimeng Biopharma, Inc.

Must not be taking: Prescription drugs

Disqualifiers: Cardiac, Hepatic, Renal, Neurological, others

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

70 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription or non-prescription drugs, including vitamins and herbal supplements, at least 7 days before the study and throughout its duration, except for acetaminophen, which is allowed in limited amounts.

What is the purpose of this trial?

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.

Research Team

Frank Lee, M.D

Principal Investigator

Frontage Clinical Services, Inc.

Eligibility Criteria

Inclusion Criteria

You are a male and you are sexually active with a female partner of child-bearing potential.

Healthy as determined by medical history, physical examination, laboratory parameters, vital signs, and ECG at Screening and Check-in.

Body mass index (BMI) ≥18.0 to ≤32.0 kg/m2 and body weight >50 kg (males) or >45 kg (females) at Screening.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single and multiple ascending oral doses of CB03-154 or placebo in a fasted state for 14 consecutive days

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CB03-154

Participant Groups

Group I: CB03-154 SAD 60mg Experimental Treatment 1 Intervention

Participants will receive CB03-154 60mg orally once daily in a fasted state.

Group II: CB03-154 SAD 5mg Experimental Treatment 1 Intervention

Participants will receive CB03-154 5mg orally once daily in a fasted state.

Group III: CB03-154 SAD 40mg Experimental Treatment 1 Intervention

Participants will receive CB03-154 40mg orally once daily in a fasted state.

Group IV: CB03-154 SAD 20mg Experimental Treatment 1 Intervention

Participants will receive CB03-154 20mg orally once daily in a fasted state.

Group V: CB03-154 SAD 10mg Experimental Treatment 1 Intervention

Participants will receive CB03-154 10mg orally once daily in a fasted state.

Group VI: CB03-154 MAD 40mg Experimental Treatment 1 Intervention

Participants will receive CB03-154 40mg orally once daily in a fasted state, for 14 consecutive days.

Group VII: CB03-154 MAD 20mg Experimental Treatment 1 Intervention

Participants will receive CB03-154 20mg orally once daily in a fasted state, for 14 consecutive days.

Group VIII: CB03-154 MAD 10mg Experimental Treatment 1 Intervention

Participants will receive CB03-154 10mg orally once daily in a fasted state, for 14 consecutive days.

Group IX: CB03-154 FE Experimental Treatment 1 Intervention

Participants will receive CB03-154 orally once daily in a fed state.

Group X: Placebo MAD 10mg Placebo Group 1 Intervention

Participants will receive placebo 10mg orally once daily in a fasted state, for 14 consecutive days.

Group XI: Placebo SAD 60mg Placebo Group 1 Intervention

Participants will receive placebo 60mg orally once daily in a fasted state.

Group XII: Placebo MAD 40mg Placebo Group 1 Intervention

Participants will receive placebo 40mg orally once daily in a fasted state, for 14 consecutive days.

Group XIII: Placebo SAD 5mg Placebo Group 1 Intervention

Participants will receive placebo 5mg orally once daily in a fasted state.

Group XIV: Placebo SAD 10mg Placebo Group 1 Intervention

Participants will receive placebo 10mg orally once daily in a fasted state.

Group XV: Placebo SAD 20mg Placebo Group 1 Intervention

Participants will receive placebo 20mg orally once daily in a fasted state.

Group XVI: Placebo SAD 40mg Placebo Group 1 Intervention

Participants will receive placebo 40mg orally once daily in a fasted state

Group XVII: Placebo MAD 20mg Placebo Group 1 Intervention

Participants will receive placebo 20mg orally once daily in a fasted state, for 14 consecutive days.

Who Is Running the Clinical Trial?

Shanghai Zhimeng Biopharma, Inc.

Lead Sponsor

Trials

8

Recruited

550+