TNM005 for Chickenpox
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.12345Why 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.678910Who 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of TNM005 or placebo, or a single dose of VARIZIG 625 IU
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
6
Treatment groups
Experimental Treatment
Active Control
TNM005 on dose level 3 /placebo
TNM005 on dose level 5 /placebo
TNM005 on dose level 4 /placebo
TNM005 on different dose level 2 /placebo
TNM005 on dose level 1 /placebo
VARIZIG 625 IU
Find a Clinic Near You
Who Is Running the Clinical Trial?
Zhuhai Trinomab Pharmaceutical Co., Ltd.
Lead Sponsor
Citations
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.
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.
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 ...
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 ...
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, ...
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 ...
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.
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 ...
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 ...
Trinomab TNM005 Injection Received IND approval from ...
The drug is intended forsusceptible individuals including immunocompromised people, pregnant women without evidence of immunity, and some ...
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