Healthy VolunteersPhase 1NCT05499260
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CB03-154 in Healthy Participants
A Phase 1 study testing CB03-154 in people with Healthy Volunteers, run by Shanghai Zhimeng Biopharma, Inc. at 1 site in United States.
Trial summary
CB03-154 is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Epilepsy. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- CB03-154
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2022to 2 Mar 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female 18 to 55 years of age, inclusive.
- Ability to understand and willingness to sign a written informed consent form.
- 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.
- If a female, must be:
- Postmenopausal, defined as amenorrhea for at least 12 months, and confirmed by serum follicle stimulating hormone (FSH) and estradiol levels at Screening, OR
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- Surgically sterile with a documented hysterectomy, partial hysterectomy, bilateral oophorectomy, or bilateral tubal ligation at least 6 months prior to Screening, OR
- If of child-bearing potential, sexually active females with male partners must be using an acceptable method of contraception such as an intrauterine device, implant or contraceptive injection, or two forms of the following (e.g., diaphragm, cervical cap, oral, patch or vaginal hormonal contraceptive, condom, spermicide, or sponge) for the last three months, and agree to continue to use their method of birth control for the duration of the study and for a minimum of one complete menstrual cycle after study completion. If a female subject is abstinent, she must agree to use an acceptable form of birth control should she become sexually active during the study.
- If a female, must have a negative pregnancy test result at Screening and Check-in.
- If a male, if sexually active with a female partner of child-bearing potential and has not had a vasectomy, must agree to use a highly effective double barrier method of contraception as deemed appropriate by the Investigator and must not donate sperm during the study and for 3 months after the last dose of study drug.
- Non-smokers (including nicotine-containing products) for at least 6 continuous months prior to the first dose by subject report.
- Willingness and ability to comply with study procedures and follow-up examination.
Who cannot join
- Reported history of or current clinically significant medical illness including but not limited to cardiac, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurological (e.g. history of epileptic seizures), or psychiatric disease.
- Reported history or presence of pro-arrhythmic conditions, including a marked baseline prolongation of QTc interval (i.e., repeated demonstration of a QTcF interval >450 milliseconds) or a history of additional significant risk factors for torsade de pointes (e.g., family history of long QT syndrome), including any evidence of QTcF prolongation at screening.
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at Screening or Check-in as deemed by the Investigator.
- Systolic blood pressure > 140 mm Hg and/or diastolic blood pressure > 90 mm Hg at Screening, and determined by the Investigator to confer a safety risk to the subject. Blood pressure measurements may be repeated after at least 10 minutes of rest if initial values obtained at Screening or Check-in are exclusionary.
- Subjects with active pathogen infections or carrier including but not limited to testing positive at Screening for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) antibody.
- Subjects with a positive test result for Coronavirus disease 2019 (COVID-19) at Check-in.
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- Donated blood or blood product or had substantial loss of blood (more than 500 mL) within 3 months prior to Screening.
- Use of any prescription or non-prescription drugs (including vitamins and herbal supplements) within 7 days prior to the first dose of study drug and throughout the study. Use of the following medication will be allowed during the study: acetaminophen (up to 1000 mg per 24 hours at the discretion of the Investigator).
- Reported history and/or recent evidence (within 2 years prior to the Screening) of alcohol abuse (e.g., for females, 4 or more drinks during a single occasion, or 8 or more drinks per week, and for males, 5 or more drinks during a single occasion, or 15 or more drinks per week), or other drug/substance use disorder.
- Positive test result for alcohol and/or drugs of abuse at Screening or Check-in.
- Known allergy or hypersensitivity to CB03-154 or any of excipients of CB03-154 tablet formulation.
- Received an experimental drug or used experimental medical device within 3 months or within 10 half-lives of the drug, whichever is longer, prior to the first dose of study drug.
- Any condition or disorder that in the Investigators' opinion would put the subject or study conduct at risk if the subject were to participate in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Frontage Clinical Services, Inc.
Secaucus, New Jersey, 07094
Peter Van Wie, PhD, 551-278-9723 ext. 121052, PVanWie@frontagelab.com
Annie Li, M.D, 201.416.7770, ali@frontagelab.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of CB03-154 in Healthy Subjects.
CB03-154 is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Epilepsy.
Read the detailed description
The purpose of this study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also test how the study drug is taken up and eliminated by the body. An additional part of the study is to look at how this could be changed by giving the study drug with food.
- Conditions
- Healthy Volunteers
- Being tested
- CB03-154, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CB03-154Drug
CB03-154 tablet once daily.
PlaceboDrug
Placebo tablet once daily.
| Study group | Role | What they receive |
|---|---|---|
| CB03-154 SAD 5mg | Experimental | Participants will receive CB03-154 5mg orally once daily in a fasted state. Receives: Drug: CB03-154 |
| Placebo SAD 5mg | Placebo comparator | Participants will receive placebo 5mg orally once daily in a fasted state. Receives: Drug: Placebo |
| CB03-154 SAD 10mg | Experimental | Participants will receive CB03-154 10mg orally once daily in a fasted state. Receives: Drug: CB03-154 |
| Placebo SAD 10mg | Placebo comparator | Participants will receive placebo 10mg orally once daily in a fasted state. Receives: Drug: Placebo |
| CB03-154 SAD 20mg | Experimental | Participants will receive CB03-154 20mg orally once daily in a fasted state. Receives: Drug: CB03-154 |
| Placebo SAD 20mg | Placebo comparator | Participants will receive placebo 20mg orally once daily in a fasted state. Receives: Drug: Placebo |
| CB03-154 SAD 40mg | Experimental | Participants will receive CB03-154 40mg orally once daily in a fasted state. Receives: Drug: CB03-154 |
| Placebo SAD 40mg | Placebo comparator | Participants will receive placebo 40mg orally once daily in a fasted state Receives: Drug: Placebo |
| CB03-154 SAD 60mg | Experimental | Participants will receive CB03-154 60mg orally once daily in a fasted state. Receives: Drug: CB03-154 |
| Placebo SAD 60mg | Placebo comparator | Participants will receive placebo 60mg orally once daily in a fasted state. Receives: Drug: Placebo |
| CB03-154 FE | Experimental | Participants will receive CB03-154 orally once daily in a fed state. Receives: Drug: CB03-154 |
| CB03-154 MAD 10mg | Experimental | Participants will receive CB03-154 10mg orally once daily in a fasted state, for 14 consecutive days. Receives: Drug: CB03-154 |
| Placebo MAD 10mg | Placebo comparator | Participants will receive placebo 10mg orally once daily in a fasted state, for 14 consecutive days. Receives: Drug: Placebo |
| CB03-154 MAD 20mg | Experimental | Participants will receive CB03-154 20mg orally once daily in a fasted state, for 14 consecutive days. Receives: Drug: CB03-154 |
| Placebo MAD 20mg | Placebo comparator | Participants will receive placebo 20mg orally once daily in a fasted state, for 14 consecutive days. Receives: Drug: Placebo |
| CB03-154 MAD 40mg | Experimental | Participants will receive CB03-154 40mg orally once daily in a fasted state, for 14 consecutive days. Receives: Drug: CB03-154 |
| Placebo MAD 40mg | Placebo comparator | Participants will receive placebo 40mg orally once daily in a fasted state, for 14 consecutive days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of CB03-154 following single and multiple ascending oral dose administration.
Number of participants with teatment-related adverse events as assessed by CTCAE V5.0 or higher
Measured: rom the signing of the consent form until 30 days following the last dose of the study drug
Secondary outcomes (2)
Maximum Plasma Concentration (Cmax) of CB03-154
Plasma will be collected at multiple timepoints from within 60 minutes pre-dose to 48 hours post-dose
Measured: From 1 hour pre-dose to 48 hours post-dose
Area Under the Plasma Concentration Versus Time Curve (AUC) of CB03-154
Plasma will be collected at multiple timepoints from within 60 minutes pre-dose to 48 hours post-dose
Measured: From 1 hour pre-dose to 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start2 May 2022
- Primary completion2 Mar 2023 (estimated)
- Study completion2 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhimeng Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Lee, M.D, Principal investigator, Frontage Clinical Services, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499260
- Sponsor's protocol ID
- CB03-154-101
- Status last verified
- Aug 2022
- First submitted
- 8 Aug 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of CB03-154 in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT05499260
- Acronym / sponsor ID
- CB03-154-101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Shanghai Zhimeng Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 May 2022 (actual)
- Primary completion
- 2 Mar 2023 (estimated)
- Study completion
- 2 Mar 2023 (estimated)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CB03-154 is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Epilepsy.
Detailed description
The purpose of this study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also test how the study drug is taken up and eliminated by the body. An additional part of the study is to look at how this could be changed by giving the study drug with food.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| CB03-154 SAD 5mg | Experimental | Drug: CB03-154Participants will receive CB03-154 5mg orally once daily in a fasted state. |
| Placebo SAD 5mg | Placebo comparator | Drug: PlaceboParticipants will receive placebo 5mg orally once daily in a fasted state. |
| CB03-154 SAD 10mg | Experimental | Drug: CB03-154Participants will receive CB03-154 10mg orally once daily in a fasted state. |
| Placebo SAD 10mg | Placebo comparator | Drug: PlaceboParticipants will receive placebo 10mg orally once daily in a fasted state. |
| CB03-154 SAD 20mg | Experimental | Drug: CB03-154Participants will receive CB03-154 20mg orally once daily in a fasted state. |
| Placebo SAD 20mg | Placebo comparator | Drug: PlaceboParticipants will receive placebo 20mg orally once daily in a fasted state. |
| CB03-154 SAD 40mg | Experimental | Drug: CB03-154Participants will receive CB03-154 40mg orally once daily in a fasted state. |
| Placebo SAD 40mg | Placebo comparator | Drug: PlaceboParticipants will receive placebo 40mg orally once daily in a fasted state |
| CB03-154 SAD 60mg | Experimental | Drug: CB03-154Participants will receive CB03-154 60mg orally once daily in a fasted state. |
| Placebo SAD 60mg | Placebo comparator | Drug: PlaceboParticipants will receive placebo 60mg orally once daily in a fasted state. |
| CB03-154 FE | Experimental | Drug: CB03-154Participants will receive CB03-154 orally once daily in a fed state. |
| CB03-154 MAD 10mg | Experimental | Drug: CB03-154Participants will receive CB03-154 10mg orally once daily in a fasted state, for 14 consecutive days. |
| Placebo MAD 10mg | Placebo comparator | Drug: PlaceboParticipants will receive placebo 10mg orally once daily in a fasted state, for 14 consecutive days. |
| CB03-154 MAD 20mg | Experimental | Drug: CB03-154Participants will receive CB03-154 20mg orally once daily in a fasted state, for 14 consecutive days. |
| Placebo MAD 20mg | Placebo comparator | Drug: PlaceboParticipants will receive placebo 20mg orally once daily in a fasted state, for 14 consecutive days. |
| CB03-154 MAD 40mg | Experimental | Drug: CB03-154Participants will receive CB03-154 40mg orally once daily in a fasted state, for 14 consecutive days. |
| Placebo MAD 40mg | Placebo comparator | Drug: PlaceboParticipants will receive placebo 40mg orally once daily in a fasted state, for 14 consecutive days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Male or female 18 to 55 years of age, inclusive.
- Ability to understand and willingness to sign a written informed consent form.
- 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.
- If a female, must be:
Key exclusion criteria (13 listed)
- Reported history of or current clinically significant medical illness including but not limited to cardiac, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurological (e.g. history of epileptic seizures), or psychiatric disease.
- Reported history or presence of pro-arrhythmic conditions, including a marked baseline prolongation of QTc interval (i.e., repeated demonstration of a QTcF interval >450 milliseconds) or a history of additional significant risk factors for torsade de pointes (e.g., family history of long QT syndrome), including any evidence of QTcF prolongation at screening.
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at Screening or Check-in as deemed by the Investigator.
- Systolic blood pressure > 140 mm Hg and/or diastolic blood pressure > 90 mm Hg at Screening, and determined by the Investigator to confer a safety risk to the subject. Blood pressure measurements may be repeated after at least 10 minutes of rest if initial values obtained at Screening or Check-in are exclusionary.
- Subjects with active pathogen infections or carrier including but not limited to testing positive at Screening for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) antibody.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CB03-154CB03-154 tablet once daily. | Drug | CB03-154 FE, CB03-154 MAD 10mg, CB03-154 MAD 20mg, CB03-154 MAD 40mg, CB03-154 SAD 10mg, CB03-154 SAD 20mg, CB03-154 SAD 40mg, CB03-154 SAD 5mg, CB03-154 SAD 60mg |
| PlaceboPlacebo tablet once daily. | Drug | Placebo MAD 10mg, Placebo MAD 20mg, Placebo MAD 40mg, Placebo SAD 10mg, Placebo SAD 20mg, Placebo SAD 40mg, Placebo SAD 5mg, Placebo SAD 60mg |
Primary outcome
To evaluate the safety and tolerability of CB03-154 following single and multiple ascending oral dose administration.
Time frame: rom the signing of the consent form until 30 days following the last dose of the study drug
Number of participants with teatment-related adverse events as assessed by CTCAE V5.0 or higher
2 secondary outcomes
Maximum Plasma Concentration (Cmax) of CB03-154
Time frame: From 1 hour pre-dose to 48 hours post-dose
Area Under the Plasma Concentration Versus Time Curve (AUC) of CB03-154
Time frame: From 1 hour pre-dose to 48 hours post-dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Lee, M.D principal investigator
Frontage Clinical Services, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CB03-154 in people with Healthy Volunteers, run by Shanghai Zhimeng Biopharma, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Van Wie, PhD ((+1) 551-278-9723 ext. 121052, PVanWie@frontagelab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of CB03-154 following single and multiple ascending oral dose administration. (time frame: rom the signing of the consent form until 30 days following the last dose of the study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.