CB03-154 for Healthy Subjects
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.12345Why 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.12367
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive single and multiple ascending oral doses of CB03-154 or placebo in a fasted state for 14 consecutive days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CB03-154
Find a Clinic Near You
Who Is Running the Clinical Trial?
Shanghai Zhimeng Biopharma, Inc.
Lead Sponsor