TNM005 for Chickenpox

Overseen By Miaoyan Chen

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd.

Must not be taking: Immunosuppressives, Monoclonal antibodies

Disqualifiers: Chronic disease, Surgery, Drug abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

48 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Ahad Sabet, MD

Principal Investigator

ICON plc

Eligibility Criteria

Healthy adults aged 18-55 with a BMI of 18.5-31 and weight over 50 kg for males, 45 kg for females can join this trial. They must have no significant health issues, not be on certain medications or have had recent surgeries, and agree to use effective contraception.

Inclusion Criteria

I am between 18 and 55 years old and consider myself healthy.

Signed and dated written informed consent

Willing and able to comply with scheduled visits, blood sampling, laboratory tests, and other study procedures

Exclusion Criteria

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

I haven't had major surgery in the last 3 months and don't plan any during the study.

History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein

Treatment Details

Interventions

• TNM005

Trial Overview The trial is testing TNM005's safety after one dose in healthy people by comparing it to VariZIG and a placebo. It looks at how the body reacts to the drug (safety), how it moves through and leaves the body (pharmacokinetics), and its effects on the body's functions (pharmacodynamics).

Participant Groups

Group I: TNM005 level 3/placebo Experimental Treatment 2 Interventions

TNM005 on dose level 3 /placebo

Group II: TNM005 dose level 5/placebo Experimental Treatment 2 Interventions

TNM005 on dose level 5 /placebo

Group III: TNM005 dose level 4/placebo Experimental Treatment 2 Interventions

TNM005 on dose level 4 /placebo

Group IV: TNM005 dose level 2/placebo Experimental Treatment 2 Interventions

TNM005 on different dose level 2 /placebo

Group V: TNM005 dose level 1/placebo Experimental Treatment 2 Interventions

TNM005 on dose level 1 /placebo

Group VI: VARIZIG Active Control 1 Intervention

VARIZIG 625 IU

Who Is Running the Clinical Trial?

Zhuhai Trinomab Pharmaceutical Co., Ltd.

Lead Sponsor

Trials

12

Recruited

3,600+