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

Last updated: August 14, 2022
Sponsor: Shanghai Zhimeng Biopharma, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Healthy Volunteers

Treatment

N/A

Clinical Study ID

NCT05499260
CB03-154-101
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female 18 to 55 years of age, inclusive.
  2. Ability to understand and willingness to sign a written informed consent form.
  3. Healthy as determined by medical history, physical examination, laboratory parameters,vital signs, and ECG at Screening and Check-in.
  4. Body mass index (BMI) ≥18.0 to ≤32.0 kg/m2 and body weight >50 kg (males) or >45 kg (females) at Screening.
  5. If a female, must be:
  • Postmenopausal, defined as amenorrhea for at least 12 months, and confirmed byserum follicle stimulating hormone (FSH) and estradiol levels at Screening, OR
  • Surgically sterile with a documented hysterectomy, partial hysterectomy,bilateral oophorectomy, or bilateral tubal ligation at least 6 months prior toScreening, OR
  • If of child-bearing potential, sexually active females with male partners must beusing 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 usetheir method of birth control for the duration of the study and for a minimum ofone complete menstrual cycle after study completion. If a female subject isabstinent, she must agree to use an acceptable form of birth control should shebecome sexually active during the study.
  1. If a female, must have a negative pregnancy test result at Screening and Check-in.
  2. If a male, if sexually active with a female partner of child-bearing potential and hasnot had a vasectomy, must agree to use a highly effective double barrier method ofcontraception as deemed appropriate by the Investigator and must not donate spermduring the study and for 3 months after the last dose of study drug.
  3. Non-smokers (including nicotine-containing products) for at least 6 continuous monthsprior to the first dose by subject report.
  4. Willingness and ability to comply with study procedures and follow-up examination.

Exclusion

Exclusion Criteria:

  1. Reported history of or current clinically significant medical illness including butnot limited to cardiac, hepatic, renal, respiratory, gastrointestinal, endocrine,immunologic, dermatologic, hematologic, neurological (e.g. history of epilepticseizures), or psychiatric disease.
  2. Reported history or presence of pro-arrhythmic conditions, including a marked baselineprolongation of QTc interval (i.e., repeated demonstration of a QTcF interval >450milliseconds) or a history of additional significant risk factors for torsade depointes (e.g., family history of long QT syndrome), including any evidence of QTcFprolongation at screening.
  3. Clinically significant abnormal values for hematology, clinical chemistry, orurinalysis at Screening or Check-in as deemed by the Investigator.
  4. Systolic blood pressure > 140 mm Hg and/or diastolic blood pressure > 90 mm Hg atScreening, 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 ifinitial values obtained at Screening or Check-in are exclusionary.
  5. Subjects with active pathogen infections or carrier including but not limited totesting positive at Screening for human immunodeficiency virus (HIV), Hepatitis Bsurface antigen (HBsAg), or Hepatitis C virus (HCV) antibody.
  6. Subjects with a positive test result for Coronavirus disease 2019 (COVID-19) atCheck-in.
  7. Donated blood or blood product or had substantial loss of blood (more than 500 mL)within 3 months prior to Screening.
  8. Use of any prescription or non-prescription drugs (including vitamins and herbalsupplements) within 7 days prior to the first dose of study drug and throughout thestudy. 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).
  9. Reported history and/or recent evidence (within 2 years prior to the Screening) ofalcohol abuse (e.g., for females, 4 or more drinks during a single occasion, or 8 ormore drinks per week, and for males, 5 or more drinks during a single occasion, or 15or more drinks per week), or other drug/substance use disorder.
  10. Positive test result for alcohol and/or drugs of abuse at Screening or Check-in.
  11. Known allergy or hypersensitivity to CB03-154 or any of excipients of CB03-154 tabletformulation.
  12. Received an experimental drug or used experimental medical device within 3 months orwithin 10 half-lives of the drug, whichever is longer, prior to the first dose ofstudy drug.
  13. Any condition or disorder that in the Investigators' opinion would put the subject orstudy conduct at risk if the subject were to participate in the study.

Study Design

Total Participants: 70
Study Start date:
May 02, 2022
Estimated Completion Date:
March 02, 2023

Study 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.

Connect with a study center

  • Nucleus Network Pty Limited

    Melbourne, 3004
    Australia

    Site Not Available

  • Frontage Clinical Services, Inc.

    Secaucus, New Jersey 07094
    United States

    Active - Recruiting

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