70 Participants Needed

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

PV
AL
Overseen ByAnnie Li, M.D
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Shanghai Zhimeng Biopharma, Inc.

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

FL

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.
See 5 more

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
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Shanghai Zhimeng Biopharma, Inc.

Lead Sponsor

Trials
8
Recruited
550+
Unbiased ResultsWe believe in providing patients with all the options.
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