Status:
UNKNOWN
A Bridging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CB06-036 in Healthy Subjects in China
Lead Sponsor:
Shanghai Zhimeng Biopharma, Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
CB06-036 is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Chronic Hepatitis B.
Eligibility Criteria
Inclusion
- Able to provide signed informed consent to participate in the study and understand the study content, procedures, and possible adverse reactions.
- Able to finish the study in accordance with the study protocol.
- Subjects (including partners) are willing to voluntarily take effective contraceptive measures within 6 months from screening until the last dose of the study drug (see Appendix 4 for specific contraceptive measures)
- Male or Female, of age ≥18 and ≤50 years.
- Body weight ≥50.0 kg for males and ≥45.0 kg for females, with BMI ≥ 18 and ≤ 28 kg/m2, BMI ＝ Body Weight (kg) / Height 2(m2).
- No clinically significant abnormal finding on vital signs or physical examination at screening.
- Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min calculated using the Modification of Diet in Renal Disease (Cockcroft-Gault MDRD) equations (see Appendix 6 for the details);
- Liver function tests within the normal range for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin at screening.
Exclusion
- Having had major trauma or underwent major surgery within 3 months before screening.
- With previous treatment, which may affect drug absorption (such as subtotal gastrectomy).
- History of blood donation or massive blood loss (\> 450 mL) within 3 months before screening.
- Suspected of having a history of allergy to any ingredient of the study drug or allergic constitution (multiple drug and food allergy).
- Smoked more than 5 cigarettes per day within 1 month before screening.
- History of drug abuse and/or alcohol abuse (alcohol use exceeds 14 units per week; 1 unit = 285 mL of beer, or 100 mL of wine, or 25 mL of distilled alcohol).
- Acute infections within 14 weeks before screening.
- Clinically significant abnormalities on clinical laboratory tests or other clinical findings within 6 months prior to screening that indicates clinically significant disease of the following (including, but not limited to, gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immunological, psychiatric, or cardiovascular disease);
- Have known or historically documented uveitis, systemic lupus erythematosus, rheumatoid arthritis, psoriasis, Sjogren's syndrome, scleroderma, and other autoimmune diseases.
- Have known or documented history of clinically significant fundus lesions (symptomatic fundus cotton-wool-spots) and retinopathy;
- Have a known or documented history of clinically significant thyroid disease;
- History of myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), Grade III or IV heart failure, or stroke within 6 months before screening.
- Plan to have surgery or be hospitalized during the study.
- Have used immunosuppressants, immunomodulators (thymosin), and cytotoxic drugs within 6 months before screening;
- Use of a class of drugs with a defined action that serves as moderately potent inhibitors or strong inducers, which can alter the activity of drug-metabolizing enzymes, etc., within 14 days before screening;
- Have used any prescription drugs, over-the-counter drugs, vitamins, herbal or other diet or supplement deemed inappropriate by the Investigator within 7 days prior to screening;
- Those who have been vaccinated within 14 days prior to screening or plan to be vaccinated during the study;
- Those who have consumed a special diet (including dragon fruit, mango, grapefruit, etc.) or exercised vigorously within 3 days before screening, or have other factors that affect drug absorption, distribution, metabolism, excretion, etc.;
- Having had chocolate, caffeine or xanthine-rich food or beverage, or any alcohol products 48 hours before study drug administration.
- Have acute illness or using concomitant medication from screening to study drug administration;
- Have had any investigational medicine or participated in the clinical study of medical devices within 3 months before screening.
- With clinically significant ECG abnormalities judged by the investigator as not suitable for study participation.
- Women of breast-feeding or with positive pregnancy test.
- Positive screening for any of Hepatitis B serological test, hepatitis C\[HCV\] antibodies, Human immunodeficiency Virus\[HIV\], or Syphilis test.
- Positive urine drug screen (morphine, marijuana) or alcohol breath test.
- Have other factors that are not suitable for study participation in the investigator's opinion.
Key Trial Info
Start Date :
September 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 29 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06101316
Start Date
September 19 2023
End Date
December 29 2023
Last Update
October 26 2023
Active Locations (1)
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1
The First Hospital of Jilin University
Changchun, Jilin, China, 130000