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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05502549




Registration number
NCT05502549
Ethics application status
Date submitted
14/08/2022
Date registered
16/08/2022
Date last updated
1/02/2024

Titles & IDs
Public title
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CB03-154 in Healthy Participants in Australia
Scientific 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
Secondary ID [1] 0 0
CB03-154-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CB03-154
Treatment: Drugs - Placebo

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

Placebo Comparator: Placebo SAD 10mg - Participants will receive placebo 10mg orally once daily in a fasted state.

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

Placebo Comparator: Placebo SAD 20mg - Participants will receive placebo 20mg orally once daily in a fasted state.

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

Placebo Comparator: Placebo SAD 30mg - Participants will receive placebo 30mg orally once daily in a fasted state.

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

Placebo Comparator: Placebo SAD 45mg - Participants will receive placebo 45mg orally once daily in a fasted state.

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

Experimental: CB03-154 MAD 10mg - Participants will receive CB03-154 10mg orally once daily in a fasted state, for 14 consecutive days.

Placebo Comparator: Placebo MAD 10mg - Participants will receive placebo 10mg orally once daily in a fasted state, for 14 consecutive days.

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

Placebo Comparator: Placebo MAD 20mg - Participants will receive placebo 20mg orally once daily in a fasted state, for 14 consecutive days.

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

Placebo Comparator: Placebo SAD 5mg - Participants will receive placebo 5mg orally once daily in a fasted state.


Treatment: Drugs: CB03-154
CB03-154 tablet once daily.

Treatment: Drugs: Placebo
Placebo tablet once daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the safety and tolerability of CB03-154 following single and multiple ascending oral dose administration.
Timepoint [1] 0 0
From the signing of the consent form until 30 days following the last dose of the study drug
Secondary outcome [1] 0 0
Maximum Plasma Concentration (Cmax) of CB03-154
Timepoint [1] 0 0
From 1 hour pre-dose to 48 hours post-dose
Secondary outcome [2] 0 0
Area Under the Plasma Concentration Versus Time Curve (AUC) of CB03-154
Timepoint [2] 0 0
From 1 hour pre-dose to 48 hours post-dose

Eligibility
Key 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 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.

6. If a female of child-bearing potential, must have a negative pregnancy test
result at Screening and Check-in.

7. 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.

8. 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.

9. Willingness and ability to comply with study procedures and follow-up
examination.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 1. 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.

2. 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.

3. 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.

5. Systolic blood pressure > 140 mm Hgand/or diastolic blood pressure > 90 mmHg or
systolic blood pressure < 90mmHg and/or diastolic blood pressure < 50mmHg 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.

6. 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.

7. Subjects with a positive test result for Coronavirus disease 2019 (COVID-19) at
Check-in.

8. Donated blood or blood product or had substantial loss of blood (more than 500 mL)
within 1 months prior to Screening.

9. 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).

10. 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.

11. Positive test result for alcohol and/or drugs of abuse at Screening or Check-in.

12. Known allergy or hypersensitivity to CB03-154 or any of excipients of CB03-154
tablet formulation.

13. 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.

14. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/12/2023
Sample size
Target
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Nucleus Network Pty Limited - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Shanghai Zhimeng Biopharma, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
CB03-154 is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the
treatment of Epilepsy.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05502549
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ofer Gonen, PhD
Address 0 0
Nucleus Network Pty Limited
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries