Clinical trial NCT06101316: A Bridging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CB06-036 in Healthy Subjects in China
Official title: A Bridging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CB06-036 in Healthy Subjects in China
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Shanghai Zhimeng Biopharma, Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: CB06-036 is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Chronic Hepatitis B.


Eligibility criteria: Inclusion Criteria:

1. Able to provide signed informed consent to participate in the study and understand the study content, procedures, and possible adverse reactions.
2. Able to finish the study in accordance with the study protocol.
3. 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)
4. Male or Female, of age ≥18 and ≤50 years.
5. 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).
6. No clinically significant abnormal finding on vital signs or physical examination at screening.
7. 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);
8. Liver function tests within the normal range for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin at screening.

Exclusion Criteria:

1. Having had major trauma or underwent major surgery within 3 months before screening.
2. With previous treatment, which may affect drug absorption (such as subtotal gastrectomy).
3. History of blood donation or massive blood loss (\> 450 mL) within 3 months before screening.
4. Suspected of having a history of allergy to any ingredient of the study drug or allergic constitution (multiple drug and food allergy).
5. Smoked more than 5 cigarettes per day within 1 month before screening.
6. 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).
7. Acute infections within 14 weeks before screening.
8. 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);
9. Have known or historically documented uveitis, systemic lupus erythematosus, rheumatoid arthritis, psoriasis, Sjogren's syndrome, scleroderma, and other autoimmune diseases.
10. Have known or documented history of clinically significant fundus lesions (symptomatic fundus cotton-wool-spots) and retinopathy;
11. Have a known or documented history of clinically significant thyroid disease;
12. 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.
13. Plan to have surgery or be hospitalized during the study.
14. Have used immunosuppressants, immunomodulators (thymosin), and cytotoxic drugs within 6 months before screening;
15. 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;
16. 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;
17. Those who have been vaccinated within 14 days prior to screening or plan to be vaccinated during the study;
18. 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.;
19. Having had chocolate, caffeine or xanthine-rich food or beverage, or any alcohol products 48 hours before study drug administration.
20. Have acute illness or using concomitant medication from screening to study drug administration;
21. Have had any investigational medicine or participated in the clinical study of medical devices within 3 months before screening.
22. With clinically significant ECG abnormalities judged by the investigator as not suitable for study participation.
23. Women of breast-feeding or with positive pregnancy test.
24. Positive screening for any of Hepatitis B serological test, hepatitis C\[HCV\] antibodies, Human immunodeficiency Virus\[HIV\], or Syphilis test.
25. Positive urine drug screen (morphine, marijuana) or alcohol breath test.
26. Have other factors that are not suitable for study participation in the investigator's opinion.

Primary outcomes:
measure: Abnormalities of vital signs (blood pressure, pulse rate, temperature, and respiration rate)
timeFrame: At Screening，Baseline，Day1，Day 3
measure: Abnormalities of physical examination
timeFrame: At Screening，Baseline，Day 3
measure: Abnormalities of 12-lead ECG
timeFrame: At Screening，Baseline，Day1，Day 3
measure: Abnormalities of clinical laboratory
timeFrame: At Screening，Baseline，Day 3
measure: Abnormalities of Ophthalmic Examination
timeFrame: At Screening，Baseline，Day 3
measure: Measure time of the maximum observed concentration 【Tmax】
timeFrame: From 0.5 hour pre-dose to 24 hours post-dose
measure: Measure maximum observed concentration【Cmax】
timeFrame: From 0.5 hour pre-dose to 24 hours post-dose
measure: Measure apparent terminal elimination half-life【t1/2】
timeFrame: From 0.5 hour pre-dose to 24 hours post-dose
measure: Measure area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
timeFrame: From 0.5 hour pre-dose to 24 hours post-dose
measure: Measure area under the plasma concentration-time curve from the first dose to the last measurable sample collection time t (AUC 0-t)
timeFrame: From 0.5 hour pre-dose to 24 hours post-dose
measure: Measure Clearance (CL/F)
timeFrame: From 0.5 hour pre-dose to 24 hours post-dose
measure: Measure apparent volume of distribution (Vz/F)
timeFrame: From 0.5 hour pre-dose to 24 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Chang chun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
affiliation: The First Hospital of Jilin University
name: Hong Zhang
role: PRINCIPAL_INVESTIGATOR
References: