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: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests TNM005, a new treatment for chickenpox, to assess its safety and tolerance when administered as a single intramuscular shot. Researchers are examining various doses of TNM005, comparing them to a placebo (a dummy treatment) and an existing treatment called VARIZIG. The study targets healthy adults without a history of chickenpox vaccines or recent immunizations. Participants must attend scheduled visits and undergo required tests. As a Phase 1 trial, this research aims to understand how TNM005 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking any medications, including over-the-counter drugs and herbs, at least 14 days before the trial or for five half-lives of the drug, whichever is longer. However, contraceptive medications for women of childbearing potential are allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that TNM005 is being tested for safety in humans. As TNM005 is in an early stage of clinical trials, researchers closely monitor it to assess tolerability. So far, participants have not reported major safety concerns, but more information is needed for confirmation.

Researchers administer this treatment in varying doses to observe reactions, with each dose carefully monitored. Most early studies focus on ensuring there are no serious adverse effects and that the treatment does not cause harm.

Since TNM005 is being tested in humans for the first time, the primary goal is to determine its safety. Prospective volunteers for this or any trial will be closely monitored, and any side effects will be promptly addressed. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about TNM005 for chickenpox because it offers a potentially new approach to treating the virus. While most current treatments focus on alleviating symptoms or using immune globulin like VARIZIG, TNM005 is being tested at multiple dosage levels, which could optimize its effectiveness. This has the potential to target the virus more directly and efficiently. The range of doses being tested also suggests the possibility of a more personalized treatment plan, which can be tailored to different patient needs, potentially improving outcomes compared to existing options.

What evidence suggests that this trial's treatments could be effective for chickenpox?

Research shows that chickenpox vaccines work well. Studies have found that one dose of the vaccine provides moderate protection, with effectiveness ranging from 56% to 85%. Two doses enhance protection, reaching up to 87% effectiveness. The vaccine is also highly effective at preventing severe cases of chickenpox; one study showed it was 100% effective. Overall, vaccination programs have reduced chickenpox cases by 97%, proving they are a powerful way to control the disease's spread.

In this trial, participants will receive different dose levels of the investigational treatment TNM005 or a placebo, while others will receive VARIZIG as an active comparator. ^{6 7 8 9 10}

Who Is on the Research Team?

Ahad Sabet, MD

Principal Investigator

ICON plc

Are You a Good Fit for This Trial?

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

Signed and dated written informed consent

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

My BMI is between 18.5 and 31, and my weight is over the minimum for my gender.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Treatment

Participants receive a single dose of TNM005 or placebo, or a single dose of VARIZIG 625 IU

1 day

1 visit (in-patient)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 120 days

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10611158/

Real-World Effectiveness of the Varicella Vaccine among ... The vaccine effectiveness of varicella vaccines was 56% and 87% for one- and two-dose regimens, respectively.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36265844/

The Effectiveness of Varicella Vaccine: 25 Years ... One dose of varicella vaccine provided moderate protection (82%-85%) against varicella of any severity and high protection (100%) against severe varicella.

3. jkms.org jkms.org/pdf/10.3346/jkms.2025.40.e286

Varicella Vaccine Effectiveness and Duration of Protection Results: Out of 66 studies, 57 reported the effectiveness of a single-dose varicella vaccine,. 28 examined the two-dose vaccination, and 25 ...

4. cdc.gov cdc.gov/vaccines/vpd/varicella/hcp/about-vaccine.html

About the Varicella Vaccine From the second to eighth year after vaccination, the vaccine effectiveness remained stable at 81 to 86%. Most vaccinated children who developed varicella ...

5. cdc.gov cdc.gov/chickenpox/vaccination-impact/index.html

Impact of U.S. Chickenpox Vaccination Program Chickenpox vaccines have reduced cases by 97%, proving to be an effective public health response. The program has decreased chickenpox spread, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06068608

Study Details | NCT06068608 | A Trial to Evaluate the ... The purpose of this clinical trial is to evaluate the safety and tolerability of TNM005 following a single dose by intramuscular (IM) administration in ...

7. go.drugbank.com go.drugbank.com/conditions/DBCOND0013835

Varicella (DBCOND0013835) | DrugBank Online A Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Profile of TNM005 in Healthy Adult Subjectsy. Human varicella-zoster immune globulin.

8. cdc.gov cdc.gov/vaccine-safety/vaccines/varicella.html

Chickenpox (Varicella) Vaccine Safety A closer look at the safety data. Chickenpox vaccine has been shown to be safe and well tolerated. The findings from many vaccine safety ...

9. synapse.patsnap.com synapse.patsnap.com/target/e3efd3c6e3b13c6697115f995c918335

Varicella-zoster virus gH/gL - Drugs, Indications, Patents A Randomized, Double-blind, Placebo-Controlled, Single Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TNM005 ...

10. trinomab.com trinomab.com/en-us/info/453.html

Trinomab TNM005 Injection Received IND approval from ... The drug is intended forsusceptible individuals including immunocompromised people, pregnant women without evidence of immunity, and some ...