A Bridging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CB06-036 in Healthy Subjects in China

NCT06101316 | Unknown Phase 1

• 1 other identifier: CB06-036-102A
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (12)

• Abnormalities of vital signs (blood pressure, pulse rate, temperature, and respiration rate)

  Vital signs safe reference range:systolic blood pressure 84-139 mmHg, diastolic blood pressure 50-89 mmHg, pulse rate 50-100 times per min, temperature 35.9-37.6℃, respiration rate 12-20 times per min

  At Screening，Baseline，Day1，Day 3

• Abnormalities of physical examination

  Medical examinations performed by physicians include:Skin, mucous membranes, lymph nodes, head, neck, chest, abdomen, spine and limbs, nervous system

  At Screening，Baseline，Day 3

• Abnormalities of 12-lead ECG

  An ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF intervals should be used. Changes in T-wave, U-wave morphology and overall ECG interpretation will be documented.

  At Screening，Baseline，Day1，Day 3

• Abnormalities of clinical laboratory

  The clinical laboratory items includes：Blood routine, blood biochemistry, urine routine, blood clotting function, A function three, C Reactive protein

  At Screening，Baseline，Day 3

• Abnormalities of Ophthalmic Examination

  Ophthalmic examinations will be performed to assess ophthalmologic findings, including direct/indirect ophthalmologic examination, slit lamp and fundoscopic examination with retinal photographs (both eyes).Photographs of the retina must be taken.

  At Screening，Baseline，Day 3

• Measure time of the maximum observed concentration 【Tmax】

  To evaluate whether there are differences in the pharmacokinetic characteristics of CB06-036 in healthy subjects in China and the United States

  From 0.5 hour pre-dose to 24 hours post-dose

• Measure maximum observed concentration【Cmax】

  To evaluate whether there are differences in the pharmacokinetic characteristics of CB06-036 in healthy subjects in China and the United States

  From 0.5 hour pre-dose to 24 hours post-dose

• Measure apparent terminal elimination half-life【t1/2】

  To evaluate whether there are differences in the pharmacokinetic characteristics of CB06-036 in healthy subjects in China and the United States

  From 0.5 hour pre-dose to 24 hours post-dose

• Measure area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)

  To evaluate whether there are differences in the pharmacokinetic characteristics of CB06-036 in healthy subjects in China and the United States

  From 0.5 hour pre-dose to 24 hours post-dose

• Measure area under the plasma concentration-time curve from the first dose to the last measurable sample collection time t (AUC 0-t)

  To evaluate whether there are differences in the pharmacokinetic characteristics of CB06-036 in healthy subjects in China and the United States

  From 0.5 hour pre-dose to 24 hours post-dose

• Measure Clearance (CL/F)

  To evaluate whether there are differences in the pharmacokinetic characteristics of CB06-036 in healthy subjects in China and the United States

  From 0.5 hour pre-dose to 24 hours post-dose

• Measure apparent volume of distribution (Vz/F)

  To evaluate whether there are differences in the pharmacokinetic characteristics of CB06-036 in healthy subjects in China and the United States

  From 0.5 hour pre-dose to 24 hours post-dose

Study Arms (1)

CB06-036 Cohort 1

EXPERIMENTAL

1.5 mg Day1, orally taken in the morning, on an empty stomach.

Drug: CB06-036

Interventions

CB06-036 DRUG

CB06-036 Capsule

CB06-036 Cohort 1

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Zhimeng Biopharma, Inc.: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

Study Officials

• Hong Zhang

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aiyun Deng

CONTACT

15800984667; adeng@corebiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: October 26, 2023
• Study Start: September 19, 2023
• Primary Completion: October 30, 2023
• Study Completion: December 29, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Locations

CN (1)