A Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Profile of TNM005 in Healthy Adult Subjectsy

Last updated: July 9, 2024
Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Throat And Tonsil Infections

Shingles

Rash

Treatment

TNM005

VariZIG

Placebo

Clinical Study ID

NCT06068608
TNM005-101
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this clinical trial is to evaluate the safety and tolerability of TNM005 following a single dose by intramuscular (IM) administration in healthy adult subjects The main questions it aims to answer are:1. safety profile;2. PK properties 3. PD properties

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Signed and dated written informed consent;
  1. Are willing and able to comply with scheduled visits, blood sampling,laboratory tests, and other study procedures;
  1. Healthy males or females, 18-55 years of age (both inclusive);
  1. Body mass index (BMI) within 18.5-31.0 kg/m2 (both inclusive) and body weight ≥50.0 kg for males and ≥45.0 kg for females;
  1. Have no clinically significant abnormality on physical examination, vitalsigns, 12-lead ECG, and clinical laboratory tests as determined by theInvestigator;
  1. Females must be either surgically sterile or under post-menopausal status atScreening or agree to use a highly effective method of contraception fromscreening until 120 days after IMP dosing. In addition, males who are sexuallyactive and partners of women of childbearing potential must agree to useeffective contraception from screening until 120 days after drugadministration.

Exclusion

Exclusion Criteria:

  1. History or evidence of any other acute or chronic disease that, in the opinionof the Investigator, may interfere with the evaluation of the safety orimmunogenicity of the drug or compromise the safety of the subject;
  1. History of surgery (except minor outpatient surgery) within three months priorto screening or planned surgery during the study;
  1. History of receiving monoclonal antibody, immunoglobulin, or blood productswithin six months prior to dosing;
  1. Receipt of systemic immunosuppressive medications;
  1. Exposure to any live attenuated vaccine within four weeks prior to drugadministration;
  1. History of receiving vaccine(s) against zoster;
  1. Use of any other drug, including over-the-counter medications, and herbs,within 14 days prior to the drug administration or five half-lives of the drug,whichever is longer, except for contraceptive medication in women ofchildbearing potential (WOCBP), or concomitant medications that are considerednecessary for the subject's welfare and unlikely to interfere with the study;
  1. Donated blood >400 mL or significant blood loss equivalent to 400 mL within onemonth before Screening; or plasma donation within 14 days before Screening; orany plan of blood or blood product donation during the study;
  1. Positive test at a screening of any of the following: hepatitis B surfaceantigen (HBsAg), hepatitis C (HCV) antibody, or human immunodeficiency virus (HIV) antigen/antibody;
  1. Known or suspected history of drug abuse within the past five years or with apositive urine drug test at Screening or on Day -1;
  1. History of significant alcohol abuse within six months prior to screening orany indication of regular use of more than 14 units of alcohol per week ortaking a product containing alcohol two days prior to dosing, or having apositive alcohol breath test on Day -1;
  1. Use of ≥five cigarettes or equivalent nicotine-containing product per day onaverage over three months prior to Screening; or unwilling to refrain fromnicotine products during study participation;
  1. History of allergic or anaphylactic reaction to a therapeutic or diagnosticmonoclonal antibody or IgG-fusion protein;
  1. History of allergic or anaphylactic reaction to blood products (only forVARIZIG cohort);
  1. IgA deficient subjects at risk for hypersensitivity reaction (only for VARIZIGcohort);
  1. Subjects at high risk for thrombotic events, including those with a history ofvenous or arterial thrombosis, atherosclerosis, or multiple cardiovascular riskfactors (only for VARIZIG cohort);
  1. Participation in any other clinical studies with chemical or biological drugsor devices within four weeks or five times the half-life of the specificdrug/biologics (whichever is longer) before drug administration;
  1. Nursing mothers or pregnant women;
  1. Subjects considered unsuitable for participating in the study in the opinion ofthe Investigator.

Study Design

Total Participants: 48
Treatment Group(s): 3
Primary Treatment: TNM005
Phase: 1
Study Start date:
September 12, 2023
Estimated Completion Date:
December 31, 2024

Study Description

This is a randomized, double-blind, placebo-controlled, single ascending dose, phase 1 study designed to evaluate the safety, tolerability, PK, PD (anti-VZV antibody level), and immunogenicity of TNM005, as well as to characterize the PD of VARIZIG, in healthy adult volunteers.

The study also includes a cohort in which eight subjects will receive a single dose of VARIZIG 625 IU. This cohort will be conducted in an open-label fashion and may be initiated as early as the first TNM005 cohort is dosed.

The study include periods of Screening (up to 28 days), in-patient (treatment on Day 1), and safety follow-up until Day 120.

Connect with a study center

  • ICON, plc

    Salt Lake City, Utah 84124
    United States

    Active - Recruiting

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