TNM005 for Chickenpox
YW
MC
Overseen ByMiaoyan Chen
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
What You Need to Know Before You Apply
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
Who Is on the Research Team?
AS
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.
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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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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?
6Treatment groups
Experimental Treatment
Active Control
Group I: TNM005 level 3/placeboExperimental Treatment2 Interventions
Group II: TNM005 dose level 5/placeboExperimental Treatment2 Interventions
Group III: TNM005 dose level 4/placeboExperimental Treatment2 Interventions
Group IV: TNM005 dose level 2/placeboExperimental Treatment2 Interventions
Group V: TNM005 dose level 1/placeboExperimental Treatment2 Interventions
Group VI: VARIZIGActive Control1 Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Zhuhai Trinomab Pharmaceutical Co., Ltd.
Lead Sponsor
Trials
12
Recruited
3,600+
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