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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
This is a randomized, double-blind, placebo-controlled, single ascending dose, phase 1 study designed to evaluate the safety, tolerability, PK, PD (anti-VZV antibody level), and immunogenicity of TNM005, as well as to characterize the PD of VARIZIG, in healthy adult volunteers.
The study also includes a cohort in which eight subjects will receive a single dose of VARIZIG 625 IU. This cohort will be conducted in an open-label fashion and may be initiated as early as the first TNM005 cohort is dosed.
The study include periods of Screening (up to 28 days), in-patient (treatment on Day 1), and safety follow-up until Day 120.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TNM005 dose level 1/placebo | Experimental | TNM005 on dose level 1 /placebo |
|
| TNM005 dose level 2/placebo | Experimental | TNM005 on different dose level 2 /placebo |
|
| TNM005 level 3/placebo | Experimental | TNM005 on dose level 3 /placebo |
|
| TNM005 dose level 4/placebo | Experimental | TNM005 on dose level 4 /placebo |
|
| TNM005 dose level 5/placebo | Experimental | TNM005 on dose level 5 /placebo |
|
| VARIZIG | Active Comparator | VARIZIG 625 IU |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNM005 | Drug | single,intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AEs | Up to 120 days post dosing | |
| Number of participants Physical examinations abnormalities | Physical examination includes assessments of general appearance, skin, lymph nodes, head.neck, lung, heart, abdomen, spine, extremities, nervous system, etc. | Up to 120 days post dosing |
| Number of participants with abnormalities of vital signs | Vital signs measured include blood pressure, pulse rate, temperature, and respiration rate. | Up to 120 days post dosing |
| Number of participants with abnormalities of 12-lead electrocardiogram (ECG) parameters | ECG parameters include heart rate, PR interval, RR interval, ORS duration, QTcF interval. | Up to 120 days post dosing |
| Number of participants with abnormalities of clinical laboratory tests | Clinical laboratory tests include hematology, biochemistry, coagulation, and urinalysis. | Up to 120 days post dosing |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t | Area under the plasma concentration-time curve from time 0 (predose) to the last time point with a detectable plasma concentration (Tlast.). | Up to 120 days post dosing |
| AUC0-∞ | Area under the plasma concentration-time curve from time 0 (predose) extrapolated to infinite time. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Wang | Contact | +86 0756 7263999 | emma.wang@trinomab.com | |
| Miaoyan Chen | Contact | +86 0756 7263999 | chenmiaoyan@trinomab.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahad Sabet, MD | ICON plc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON, plc | Recruiting | Salt Lake City | Utah | 84124 | United States |
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| ID | Term |
|---|---|
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| C030799 | varicella-zoster immune globulin |
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| Placebo | Drug | single,intramuscular injection |
|
| VariZIG | Drug | a single dose of VARIZIG 625 IU,intramuscular injection |
|
| Up to 120 days post dosing |
| Cmax | Maximum plasma concentration | Up to 120days post dosing |
| Tmax | Time to reach maximum plasma concentration | Up to 120 days post dosing |
| t1/2 | Elimination half-life | Up to 120days post dosing |
| λz | Terminal disposition rate constant | Up to 120days post dosing |
| CL/F | Apparent clearance | Up to 120days post dosing |
| Vd/F | Apparent volume of distribution | Up to 120days post dosing |
| t1/2 of anti-varicella-zoster virus (VZV) antibody level (both baseline corrected and uncorrected) | Elimination half-life of antibody level of anti-VZV | Up to 120days post dosing |
| ADA | Incidence of anti-drug antibody (ADA) to TNM005 in serum | Up to 120days post dosing |
| D007239 | Infections |