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

NCT05502549 | Completed Phase 1 FDA Drug

• 1 other identifier: CB03-154-102
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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

  From 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

  From 1 hour pre-dose to 48 hours post-dose

• Area Under the Plasma Concentration Versus Time Curve (AUC) of CB03-154

  From 1 hour pre-dose to 48 hours post-dose

Study Arms (15)

CB03-154 SAD 10mg

EXPERIMENTAL

Participants will receive CB03-154 10mg orally once daily in a fasted state.

Drug: CB03-154

Placebo SAD 10mg

PLACEBO COMPARATOR

Participants will receive placebo 10mg orally once daily in a fasted state.

Drug: Placebo

CB03-154 SAD 20mg

EXPERIMENTAL

Participants will receive CB03-154 20mg orally once daily in a fasted state.

Drug: CB03-154

Placebo SAD 20mg

PLACEBO COMPARATOR

Participants will receive placebo 20mg orally once daily in a fasted state.

Drug: Placebo

CB03-154 SAD 30mg

EXPERIMENTAL

Participants will receive CB03-154 30mg orally once daily in a fasted state.

Drug: CB03-154

Placebo SAD 30mg

PLACEBO COMPARATOR

Participants will receive placebo 30mg orally once daily in a fasted state.

Drug: Placebo

CB03-154 SAD 45mg

EXPERIMENTAL

Participants will receive CB03-154 45mg orally once daily in a fasted state.

Drug: CB03-154

Placebo SAD 45mg

PLACEBO COMPARATOR

Participants will receive placebo 45mg orally once daily in a fasted state.

Drug: Placebo

CB03-154 FE 20mg

EXPERIMENTAL

Participants will receive CB03-154 20mg orally once daily in a fed state.

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.

Drug: CB03-154

Placebo MAD 10mg

PLACEBO COMPARATOR

Participants will receive placebo 10mg orally once daily in a fasted state, for 14 consecutive days.

Drug: Placebo

CB03-154 MAD 20mg

EXPERIMENTAL

Participants will receive CB03-154 20mg orally once daily in a fasted state, for 14 consecutive days.

Drug: CB03-154

Placebo MAD 20mg

PLACEBO COMPARATOR

Participants will receive placebo 20mg orally once daily in a fasted state, for 14 consecutive days.

Drug: Placebo

CB03-154 SAD 5mg

EXPERIMENTAL

Participants will receive CB03-154 5mg orally once daily in a fasted state.

Drug: CB03-154

Placebo SAD 5mg

PLACEBO COMPARATOR

Participants will receive placebo 5mg orally once daily in a fasted state.

Drug: Placebo

Interventions

CB03-154 DRUG

CB03-154 tablet once daily.

CB03-154 FE 20mg; CB03-154 MAD 10mg; CB03-154 MAD 20mg; CB03-154 SAD 10mg; CB03-154 SAD 20mg; CB03-154 SAD 30mg; CB03-154 SAD 45mg; CB03-154 SAD 5mg

Placebo DRUG

Placebo tablet once daily.

Placebo MAD 10mg; Placebo MAD 20mg; Placebo SAD 10mg; Placebo SAD 20mg; Placebo SAD 30mg; Placebo SAD 45mg; Placebo SAD 5mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Male or female 18 to 55 years of age, inclusive. 2. 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
• 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, 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 once she become sexually active during the study.
• \. If a female of child-bearing potential, 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 or light-smoker (less than 10 per week)(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.

You may not qualify if:

• \. 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.
• \. Reported epileptiform discharges in the sleep-deprived EEG during screening. 4. Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at Screening or Check-in as deemed by the Investigator.
• \. 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.
• \. Donated blood or blood product or had substantial loss of blood (more than 500 mL) within 1 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 12weeks 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.

Sponsors & Collaborators

• Shanghai Zhimeng Biopharma, Inc.: lead

Study Sites (1)

Nucleus Network Pty Limited

Melbourne, 3004, Australia

Location

Study Officials

• Ofer Gonen, PhD

  Nucleus Network Pty Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2022
• First Posted: August 16, 2022
• Study Start: November 29, 2022
• Primary Completion: November 9, 2023
• Study Completion: December 15, 2023
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)