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TNM005 for Chickenpox

Phase 1
Waitlist Available
Led By Ahad Sabet, MD
Research Sponsored by Zhuhai Trinomab Pharmaceutical Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy males or females, 18-55 years of age (both inclusive)
Body mass index (BMI) within 18.5-31.0 kg/m2 (both inclusive) and body weight ≥50.0 kg for males and ≥45.0 kg for females
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 120days post dosing
Awards & highlights

Study Summary

This trial is to test the safety and side effects of a drug given as a single dose to healthy adults. It will also measure the drug's effectiveness.

Who is the study for?
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.Check my eligibility
What is being tested?
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).See study design
What are the potential side effects?
Potential side effects are not detailed here but generally could include reactions at the injection site, general discomfort or changes in vital signs that will be closely monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 55 years old and consider myself healthy.
Select...
My BMI is between 18.5 and 31, and my weight is over the minimum for my gender.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 120days post dosing
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 120days post dosing for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of AEs
Number of participants Physical examinations abnormalities
Number of participants with abnormalities of 12-lead electrocardiogram (ECG) parameters
+2 more
Secondary outcome measures
ADA
AUC0-t
AUC0-∞
+7 more

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Zhuhai Trinomab Pharmaceutical Co., Ltd.Lead Sponsor
9 Previous Clinical Trials
3,285 Total Patients Enrolled
Ahad Sabet, MDPrincipal InvestigatorICON plc
2 Previous Clinical Trials
77 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Food and Drug Administration sanctioned VARIZIG for public consumption?

"Our team at Power has rated VARIZIG's safety with a score of 1, as this is an early-phase trial which only provides minimal data in terms of both efficacy and safety."

Answered by AI

Is it feasible to participate in this clinical experiment?

"To be considered for participation in this clinical trial, applicants must possess an active case of chickenpox and lie within the age range 18-55. This study is aiming to enroll 48 individuals."

Answered by AI

Does this study account for those under the age of 65?

"To be eligible for this trial, patients must fall between 18-55 years old. There are 9 studies for minors and 4 trials specifically targeting the elderly population."

Answered by AI

Is the enrollment phase of this study currently open?

"As per the information posted on clinicaltrials.gov, this research project is not presently recruiting volunteers. Since its launch in October 5th 2023 and last update of September 28th 2023, there are no open invitations to participate. Nevertheless, 13 other trials have vacancies for participants at this current moment in time."

Answered by AI

What is the ultimate aim of this clinical research?

"According to the sponsor, Zhuhai Trinomab Pharmaceutical Co., Ltd., this clinical trial's primary outcome is the number of patients with 12-lead ECG abnormalities after 120 days. Secondary goals include assessing AUC0-∞ (the area under a particular plasma concentration curve), Cmax (maximum plasma concentration) and Tmax (time to reach maximum plasma concentration)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Profile of TNM005 in Healthy Adult Subjectsy
2023. "A Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Profile of TNM005 in Healthy Adult Subjectsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06068608.
~24 spots leftby Dec 2024
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