CB03-154 for Healthy Subjects

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and metabolism of a new investigational drug, CB03-154, developed to treat epilepsy. Participants will receive either varying doses of CB03-154 or a placebo for comparison. The study seeks healthy, non-smoking individuals without epilepsy or other significant medical conditions. Those without ongoing medical conditions and not taking other medications may qualify. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects on people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CB03-154 is safe and well-tolerated in earlier studies. For example, in a study involving patients with Amyotrophic Lateral Sclerosis (ALS), researchers administered different doses of CB03-154, and participants generally tolerated it well without major safety issues. Another study examining its effects on the brain and nervous system also found it to be safe and well-tolerated.

These results suggest that CB03-154 is likely to be well-tolerated in people. However, like any new drug being tested, there is always a chance of side effects. Still, the information available so far is promising for those considering joining the trials. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for epilepsy?

Researchers are excited about CB03-154 because it offers a fresh approach compared to standard hormone-based treatments. Unlike typical therapies that often focus on hormone pathways, CB03-154 is designed with a novel mechanism that targets specific enzymes involved in metabolic processes. This could potentially lead to fewer side effects and more tailored effectiveness. Additionally, its oral delivery method ensures easy administration, which might improve patient compliance compared to treatments requiring injections or complex regimens.

What evidence suggests that CB03-154 might be an effective treatment for epilepsy?

Research suggests that CB03-154, which participants in this trial may receive, could help treat conditions like ALS, a disease affecting nerve cells in the brain and spinal cord. Early studies have shown it can calm overactive nerve cells, potentially slowing the disease's progression. While researchers have primarily studied CB03-154 for ALS, they are now also investigating its use for epilepsy. It works by opening certain channels in the brain, which may help stabilize nerve activity. These early results are promising, but further research is needed to confirm its effectiveness for epilepsy. ^{1 2 3 6 7}

Who Is on the Research Team?

Frank Lee, M.D

Principal Investigator

Frontage Clinical Services, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• CB03-154

How Is the Trial Designed?

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+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07082192

NCT07082192 | A Study to Evaluate the Efficacy and ...

A Study to Evaluate the Efficacy and Safety of Different Doses of CB03-154 in Adult Patients With Amyotrophic Lateral Sclerosis (ALS).

2.

alsnewstoday.com

alsnewstoday.com/news/zhimeng-cleared-launch-phase-2-3-study-als-therapy-cb03-154-china/

Zhimeng cleared to launch study of ALS therapy CB03-154 ...

The findings so far show promising safety and tolerability results. CB03-154 has won orphan drug status for ALS in the U.S., a designation that ...

3.

core-biopharma.com

core-biopharma.com/news/75.html

News

In July this year, CB03-154 received clinical trial approval from the Center for Drug Evaluation (CDE) of the National Medical Products ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05499260

NCT05499260 | A Study to Evaluate the Safety, Tolerability ...

Study Overview. Brief Summary. CB03-154 is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Epilepsy.

5.

prnewswire.com

prnewswire.com/news-releases/zhimeng-biopharmas-next-generation-kcnq23-potassium-channel-opener-receives-clinical-trial-approval-for-als-phase-23-study-302500086.html

Zhimeng Biopharma's Next-Generation KCNQ2/3 ...

Preclinical studies have demonstrated that CB03-154 significantly reduces the hyperexcitability of ALS motor neurons, markedly slows the ...

6.

ctv.veeva.com

ctv.veeva.com/study/a-study-to-evaluate-the-safety-tolerability-and-efficacy-of-cb03-154-in-adult-patients-with-focal

A Study to Evaluate the Safety, Tolerability, and Efficacy of ...

The purpose of this study is to evaluate the effectiveness of CB03-154 on focal seizure frequency by comparing with placebo, see how safe the ...

7.

aesnet.org

aesnet.org/abstractslisting/quantitative-analysis-of-continuous-eeg-in-a-phase-1-study-of-a-novel-potassium-channel-opener-cb03-154-to-assess-the-safety-and-tolerability

quantitative analysis of continuous eeg in a phase 1 study of a ...

In a first-in-human Phase 1 study, CB03-154 was found to be safe and well tolerated. Many Central Nervous System (CNS) active drugs have effects ...