TNM005 for Chickenpox
AS
Overseen byAhad Sabet, MD
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd.
No Placebo Group
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
AS
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
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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
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Treatment Details
Interventions
- TNM005 (Other)
Trial OverviewThe 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
6Treatment groups
Experimental Treatment
Active Control
Group I: TNM005 level 3/placeboExperimental Treatment2 Interventions
TNM005 on dose level 3 /placebo
Group II: TNM005 dose level 5/placeboExperimental Treatment2 Interventions
TNM005 on dose level 5 /placebo
Group III: TNM005 dose level 4/placeboExperimental Treatment2 Interventions
TNM005 on dose level 4 /placebo
Group IV: TNM005 dose level 2/placeboExperimental Treatment2 Interventions
TNM005 on different dose level 2 /placebo
Group V: TNM005 dose level 1/placeboExperimental Treatment2 Interventions
TNM005 on dose level 1 /placebo
Group VI: VARIZIGActive Control1 Intervention
VARIZIG 625 IU
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Who Is Running the Clinical Trial?
Zhuhai Trinomab Pharmaceutical Co., Ltd.
Lead Sponsor
Trials
12
Recruited
3,600+