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Phase 1 Study of 162, a Novel Neutralizing Antibody Targeting Hepatitis B Surface Antigen, in Healthy Adult Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Phase 1 Study of 162, a Novel Neutralizing Antibody Targeting Hepatitis B Surface Antigen, in Healthy Adult Subjects

A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics of 162 With a Single Ascending Dose in Healthy Adult Subjects

NCT05310487•Yangshengtang Co., Ltd

View on ClinicalTrials.gov

Summary

This is the first in human study of 162, and the primary objective is to evaluate the safety and tolerability of 162 with a single ascending dose in healthy adult subjects. The dose-escalation stage will be conducted sequentially at 5 dose levels, which are 100 mg in the pre-test, and 200 mg, 400 mg, 800 mg and 1200 mg in the formal test. Two healthy adult subjects will be enrolled at 100 mg dose level and all given 162. Eight healthy adult subjects will be enrolled at each remaining dose levels (200 mg, 400 mg, 800 mg and 1200 mg), respectively.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Volunteer to participate in the study, be able to understand the requirements of a clinical study, and sign informed consent form.
•2. Aged ≥ 18 and ≤ 55 years older, male and female.
•3. Body weight ≥ 50 kg for male, body weight ≥ 45 kg for female, and body mass index (BMI) scores between ≥ 18 kg/m2 and ≤ 32.0 kg/m2.
•4. Vital signs, physical examination, laboratory tests and 12-lead ECG, etc. within normal limits; or, with no clinically significant abnormalities as determined by the investigator.
•5. A male participant must agree to use adequate contraception from screening through at least 12 weeks after the last dose of investigational product or placebo. Refer to Section 5.5 for more information on highly effective methods of contraception.
•6. Women of childbearing potential must have a negative pregnancy test prior to the dosing administration, and agree to use adequate contraception from screening through at least 12 weeks after the last dose of investigational product or placebo. A female participant of non-childbearing potential will have had at least 12 continuous months of natural (spontaneous) amenorrhoea, follicle stimulating hormone (FSH) level \> 40 mIU/mL at screening, and an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms); or have had surgical bilateral oophorectomy, hysterectomy or tubal ligation beyond 6 weeks prior to screening. Refer to Section 5.5 for more information on highly effective methods of contraception

Exclusion Criteria

•1. History of anaphylaxis or clinically significant drug allergy or drug allergy witnessed in previous studies with experimental drugs, or allergy to the active ingredients or excipients of the investigational product.
•2. History of allergic reactions to monoclonal antibodies or antibody fragments.
•3. History or presence of infectious or non-infectious liver disease, including but not limited to a history of alcoholic liver disease, non-alcoholic steatohepatitis, drug or autoimmune liver disease.
•4. History or presence of immune-mediated diseases, including but not limited to idiopathic thrombocytopenic purpura, systemic lupus erythematosus, rheumatoid arthritis.
•5. History or presence of any chronic infectious condition, including but not limited to tuberculosis or parasitic infections.
•6. History of allogenic transplantation of organs, bone marrow or stem cell.
•7. Active infection, or screening for infectious disease during the screening period (HBsAg, hepatitis C virus antibody \[HCV-Ab\], human immunodeficiency virus antibody \[HIV-Ab\], or syphilis antibody \[TP-Ab\]) is positive.
•8. QTcF \>450 msec on 3 consecutive ECG recordings conducted at screening or baseline.
•9. Alanine transaminase (ALT) \> 1.2 × ULN, aspartate aminotransferase (AST) \> 1.2 × ULN or total bilirubin \> 1.2 × ULN.
•10. Any other concomitant disease, condition or treatment that could interfere with the conduct of the study or that would, in the opinion of the Investigator or Sponsor, pose an unacceptable risk to the subject in the study or interfere with the interpretation of study data.
+7 more criteria

Locations (1)

Nucleus Network Pty Ltd

Melbourne, Australia

Key Dates

Start Date

September 30, 2022

Primary Completion Date

October 3, 2023

Completion Date

October 22, 2023

Last Updated

November 27, 2023

Enrollment

ACTUAL participants

Conditions

Chronic Hepatitis B

Interventions

162

BIOLOGICAL

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 27, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Phase 1 Study of 162, a Novel Neutralizing Antibody Targeting Hepatitis B Surface Antigen, in Healthy Adult Subjects

Inclusion Criteria

Exclusion Criteria

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