Evaluating the safety and effects of TNM005 in healthy adults

A Randomized, Double-blind, Placebo-Controlled, Single Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TNM005 and to Characterize the Pharmacodynamics of TNM005 and VARIZIG in Healthy Adult Volunteers

This study is testing a new treatment called TNM005 in healthy adults to see if it's safe and how it affects their immune system compared to a standard treatment.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Salt Lake City, Utah)
• Trial ID: NCT06068608 on ClinicalTrials.gov

What this trial studies

This clinical trial is designed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TNM005 administered via intramuscular injection in healthy adult volunteers. It is a randomized, double-blind, placebo-controlled study that includes a single ascending dose approach. Participants will undergo screening, treatment, and safety follow-up periods, with some receiving a comparison treatment of VARIZIG. The study aims to gather data on the immune response to the treatment and its overall safety profile.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18-55 with a BMI between 18.5 and 31.0 kg/m2.

Not a fit: Patients with significant health abnormalities or those outside the specified age and BMI range may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could lead to a better understanding of TNM005's safety and effectiveness, potentially improving treatment options for varicella.

How similar studies have performed: While this approach is not widely tested, similar studies evaluating safety and immunogenicity of new treatments have shown promise.

Eligibility criteria

Inclusion Criteria:

* 1) Signed and dated written informed consent;
* 2) Are willing and able to comply with scheduled visits, blood sampling, laboratory tests, and other study procedures;
* 3) Healthy males or females, 18-55 years of age (both inclusive);
* 4) 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;
* 5) Have no clinically significant abnormality on physical examination, vital signs, 12-lead ECG, and clinical laboratory tests as determined by the Investigator;
* 6) Females must be either surgically sterile or under post-menopausal status at Screening or agree to use a highly effective method of contraception from screening until 120 days after IMP dosing. In addition, males who are sexually active and partners of women of childbearing potential must agree to use effective contraception from screening until 120 days after drug administration.

Exclusion Criteria:

* 1) History or evidence of any other acute or chronic disease that, in the opinion of the Investigator, may interfere with the evaluation of the safety or immunogenicity of the drug or compromise the safety of the subject;
* 2) History of surgery (except minor outpatient surgery) within three months prior to screening or planned surgery during the study;
* 3) History of receiving monoclonal antibody, immunoglobulin, or blood products within six months prior to dosing;
* 4) Receipt of systemic immunosuppressive medications;
* 5) Exposure to any live attenuated vaccine within four weeks prior to drug administration;
* 6) History of receiving vaccine(s) against zoster;
* 7) 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 of childbearing potential (WOCBP), or concomitant medications that are considered necessary for the subject's welfare and unlikely to interfere with the study;
* 8) Donated blood \>400 mL or significant blood loss equivalent to 400 mL within one month before Screening; or plasma donation within 14 days before Screening; or any plan of blood or blood product donation during the study;
* 9) Positive test at a screening of any of the following: hepatitis B surface antigen (HBsAg), hepatitis C (HCV) antibody, or human immunodeficiency virus (HIV) antigen/antibody;
* 10) Known or suspected history of drug abuse within the past five years or with a positive urine drug test at Screening or on Day -1;
* 11) History of significant alcohol abuse within six months prior to screening or any indication of regular use of more than 14 units of alcohol per week or taking a product containing alcohol two days prior to dosing, or having a positive alcohol breath test on Day -1;
* 12) Use of ≥five cigarettes or equivalent nicotine-containing product per day on average over three months prior to Screening; or unwilling to refrain from nicotine products during study participation;
* 13) History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein;
* 14) History of allergic or anaphylactic reaction to blood products (only for VARIZIG cohort);
* 15) IgA deficient subjects at risk for hypersensitivity reaction (only for VARIZIG cohort);
* 16) Subjects at high risk for thrombotic events, including those with a history of venous or arterial thrombosis, atherosclerosis, or multiple cardiovascular risk factors (only for VARIZIG cohort);
* 17) Participation in any other clinical studies with chemical or biological drugs or devices within four weeks or five times the half-life of the specific drug/biologics (whichever is longer) before drug administration;
* 18) Nursing mothers or pregnant women;
* 19) Subjects considered unsuitable for participating in the study in the opinion of the Investigator.

Where this trial is running

Salt Lake City, Utah

• ICON, plc — Salt Lake City, Utah, United States (Recruiting)

Study contacts

• Principal investigator: Ahad Sabet, MD — ICON plc
• Study coordinator: Ying Wang

Conditions Varicella