search
Back to results

A Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Profile of TNM005 in Healthy Adult Subjectsy

Primary Purpose

Varicella

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TNM005
Placebo
VariZIG
Sponsored by
Zhuhai Trinomab Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Varicella

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 1) Signed and dated written informed consent; 2) Are willing and able to comply with scheduled visits, blood sampling, laboratory tests, and other study procedures; 3) Healthy males or females, 18-55 years of age (both inclusive); 4) 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; 5) Have no clinically significant abnormality on physical examination, vital signs, 12-lead ECG, and clinical laboratory tests as determined by the Investigator; 6) Females must be either surgically sterile or under post-menopausal status at Screening or agree to use a highly effective method of contraception from screening until 120 days after IMP dosing. In addition, males who are sexually active and partners of women of childbearing potential must agree to use effective contraception from screening until 120 days after drug administration. Exclusion Criteria: 1) History or evidence of any other acute or chronic disease that, in the opinion of the Investigator, may interfere with the evaluation of the safety or immunogenicity of the drug or compromise the safety of the subject; 2) History of surgery (except minor outpatient surgery) within three months prior to screening or planned surgery during the study; 3) History of receiving monoclonal antibody, immunoglobulin, or blood products within six months prior to dosing; 4) Receipt of systemic immunosuppressive medications; 5) Exposure to any live attenuated vaccine within four weeks prior to drug administration; 6) History of receiving vaccine(s) against zoster; 7) Use of any other drug, including over-the-counter medications, and herbs, within 14 days prior to the drug administration or five half-lives of the drug, whichever is longer, except for contraceptive medication in women of childbearing potential (WOCBP), or concomitant medications that are considered necessary for the subject's welfare and unlikely to interfere with the study; 8) Donated blood >400 mL or significant blood loss equivalent to 400 mL within one month before Screening; or plasma donation within 14 days before Screening; or any plan of blood or blood product donation during the study; 9) Positive test at a screening of any of the following: hepatitis B surface antigen (HBsAg), hepatitis C (HCV) antibody, or human immunodeficiency virus (HIV) antigen/antibody; 10) 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; 11) History of significant alcohol abuse within six months prior to screening or any indication of regular use of more than 14 units of alcohol per week or taking a product containing alcohol two days prior to dosing, or having a positive alcohol breath test on Day -1; 12) Use of ≥five cigarettes or equivalent nicotine-containing product per day on average over three months prior to Screening; or unwilling to refrain from nicotine products during study participation; 13) History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein; 14) History of allergic or anaphylactic reaction to blood products (only for VARIZIG cohort); 15) IgA deficient subjects at risk for hypersensitivity reaction (only for VARIZIG cohort); 16) Subjects at high risk for thrombotic events, including those with a history of venous or arterial thrombosis, atherosclerosis, or multiple cardiovascular risk factors (only for VARIZIG cohort); 17) Participation in any other clinical studies with chemical or biological drugs or devices within four weeks or five times the half-life of the specific drug/biologics (whichever is longer) before drug administration; 18) Nursing mothers or pregnant women; 19) Subjects considered unsuitable for participating in the study in the opinion of the Investigator.

Sites / Locations

  • ICON, plc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

TNM005 dose level 1/placebo

TNM005 dose level 2/placebo

TNM005 level 3/placebo

TNM005 dose level 4/placebo

TNM005 dose level 5/placebo

VARIZIG

Arm Description

TNM005 on dose level 1 /placebo

TNM005 on different dose level 2 /placebo

TNM005 on dose level 3 /placebo

TNM005 on dose level 4 /placebo

TNM005 on dose level 5 /placebo

VARIZIG 625 IU

Outcomes

Primary Outcome Measures

Incidence of AEs
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.
Number of participants with abnormalities of vital signs
Vital signs measured include blood pressure, pulse rate, temperature, and respiration rate.
Number of participants with abnormalities of 12-lead electrocardiogram (ECG) parameters
ECG parameters include heart rate, PR interval, RR interval, ORS duration, QTcF interval.
Number of participants with abnormalities of clinical laboratory tests
Clinical laboratory tests include hematology, biochemistry, coagulation, and urinalysis.

Secondary Outcome Measures

AUC0-t
Area under the plasma concentration-time curve from time 0 (predose) to the last time point with a detectable plasma concentration (Tlast.).
AUC0-∞
Area under the plasma concentration-time curve from time 0 (predose) extrapolated to infinite time.
Cmax
Maximum plasma concentration
Tmax
Time to reach maximum plasma concentration
t1/2
Elimination half-life
λz
Terminal disposition rate constant
CL/F
Apparent clearance
Vd/F
Apparent volume of distribution
t1/2 of anti-varicella-zoster virus (VZV) antibody level (both baseline corrected and uncorrected)
Elimination half-life of antibody level of anti-VZV
ADA
Incidence of anti-drug antibody (ADA) to TNM005 in serum

Full Information

First Posted
September 16, 2023
Last Updated
September 28, 2023
Sponsor
Zhuhai Trinomab Pharmaceutical Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT06068608
Brief Title
A Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Profile of TNM005 in Healthy Adult Subjectsy
Official Title
A Randomized, Double-blind, Placebo-Controlled, Single Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TNM005 and to Characterize the Pharmacodynamics of TNM005 and VARIZIG in Healthy Adult Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 5, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhuhai Trinomab Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicella

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TNM005 dose level 1/placebo
Arm Type
Experimental
Arm Description
TNM005 on dose level 1 /placebo
Arm Title
TNM005 dose level 2/placebo
Arm Type
Experimental
Arm Description
TNM005 on different dose level 2 /placebo
Arm Title
TNM005 level 3/placebo
Arm Type
Experimental
Arm Description
TNM005 on dose level 3 /placebo
Arm Title
TNM005 dose level 4/placebo
Arm Type
Experimental
Arm Description
TNM005 on dose level 4 /placebo
Arm Title
TNM005 dose level 5/placebo
Arm Type
Experimental
Arm Description
TNM005 on dose level 5 /placebo
Arm Title
VARIZIG
Arm Type
Active Comparator
Arm Description
VARIZIG 625 IU
Intervention Type
Drug
Intervention Name(s)
TNM005
Intervention Description
single,intramuscular injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
single,intramuscular injection
Intervention Type
Drug
Intervention Name(s)
VariZIG
Intervention Description
a single dose of VARIZIG 625 IU,intramuscular injection
Primary Outcome Measure Information:
Title
Incidence of AEs
Time Frame
Up to 120 days post dosing
Title
Number of participants Physical examinations abnormalities
Description
Physical examination includes assessments of general appearance, skin, lymph nodes, head.neck, lung, heart, abdomen, spine, extremities, nervous system, etc.
Time Frame
Up to 120 days post dosing
Title
Number of participants with abnormalities of vital signs
Description
Vital signs measured include blood pressure, pulse rate, temperature, and respiration rate.
Time Frame
Up to 120 days post dosing
Title
Number of participants with abnormalities of 12-lead electrocardiogram (ECG) parameters
Description
ECG parameters include heart rate, PR interval, RR interval, ORS duration, QTcF interval.
Time Frame
Up to 120 days post dosing
Title
Number of participants with abnormalities of clinical laboratory tests
Description
Clinical laboratory tests include hematology, biochemistry, coagulation, and urinalysis.
Time Frame
Up to 120 days post dosing
Secondary Outcome Measure Information:
Title
AUC0-t
Description
Area under the plasma concentration-time curve from time 0 (predose) to the last time point with a detectable plasma concentration (Tlast.).
Time Frame
Up to 120 days post dosing
Title
AUC0-∞
Description
Area under the plasma concentration-time curve from time 0 (predose) extrapolated to infinite time.
Time Frame
Up to 120 days post dosing
Title
Cmax
Description
Maximum plasma concentration
Time Frame
Up to 120days post dosing
Title
Tmax
Description
Time to reach maximum plasma concentration
Time Frame
Up to 120 days post dosing
Title
t1/2
Description
Elimination half-life
Time Frame
Up to 120days post dosing
Title
λz
Description
Terminal disposition rate constant
Time Frame
Up to 120days post dosing
Title
CL/F
Description
Apparent clearance
Time Frame
Up to 120days post dosing
Title
Vd/F
Description
Apparent volume of distribution
Time Frame
Up to 120days post dosing
Title
t1/2 of anti-varicella-zoster virus (VZV) antibody level (both baseline corrected and uncorrected)
Description
Elimination half-life of antibody level of anti-VZV
Time Frame
Up to 120days post dosing
Title
ADA
Description
Incidence of anti-drug antibody (ADA) to TNM005 in serum
Time Frame
Up to 120days post dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1) Signed and dated written informed consent; 2) Are willing and able to comply with scheduled visits, blood sampling, laboratory tests, and other study procedures; 3) Healthy males or females, 18-55 years of age (both inclusive); 4) 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; 5) Have no clinically significant abnormality on physical examination, vital signs, 12-lead ECG, and clinical laboratory tests as determined by the Investigator; 6) Females must be either surgically sterile or under post-menopausal status at Screening or agree to use a highly effective method of contraception from screening until 120 days after IMP dosing. In addition, males who are sexually active and partners of women of childbearing potential must agree to use effective contraception from screening until 120 days after drug administration. Exclusion Criteria: 1) History or evidence of any other acute or chronic disease that, in the opinion of the Investigator, may interfere with the evaluation of the safety or immunogenicity of the drug or compromise the safety of the subject; 2) History of surgery (except minor outpatient surgery) within three months prior to screening or planned surgery during the study; 3) History of receiving monoclonal antibody, immunoglobulin, or blood products within six months prior to dosing; 4) Receipt of systemic immunosuppressive medications; 5) Exposure to any live attenuated vaccine within four weeks prior to drug administration; 6) History of receiving vaccine(s) against zoster; 7) Use of any other drug, including over-the-counter medications, and herbs, within 14 days prior to the drug administration or five half-lives of the drug, whichever is longer, except for contraceptive medication in women of childbearing potential (WOCBP), or concomitant medications that are considered necessary for the subject's welfare and unlikely to interfere with the study; 8) Donated blood >400 mL or significant blood loss equivalent to 400 mL within one month before Screening; or plasma donation within 14 days before Screening; or any plan of blood or blood product donation during the study; 9) Positive test at a screening of any of the following: hepatitis B surface antigen (HBsAg), hepatitis C (HCV) antibody, or human immunodeficiency virus (HIV) antigen/antibody; 10) 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; 11) History of significant alcohol abuse within six months prior to screening or any indication of regular use of more than 14 units of alcohol per week or taking a product containing alcohol two days prior to dosing, or having a positive alcohol breath test on Day -1; 12) Use of ≥five cigarettes or equivalent nicotine-containing product per day on average over three months prior to Screening; or unwilling to refrain from nicotine products during study participation; 13) History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein; 14) History of allergic or anaphylactic reaction to blood products (only for VARIZIG cohort); 15) IgA deficient subjects at risk for hypersensitivity reaction (only for VARIZIG cohort); 16) Subjects at high risk for thrombotic events, including those with a history of venous or arterial thrombosis, atherosclerosis, or multiple cardiovascular risk factors (only for VARIZIG cohort); 17) Participation in any other clinical studies with chemical or biological drugs or devices within four weeks or five times the half-life of the specific drug/biologics (whichever is longer) before drug administration; 18) Nursing mothers or pregnant women; 19) Subjects considered unsuitable for participating in the study in the opinion of the Investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Wang
Phone
+86 0756 7263999
Email
emma.wang@trinomab.com
First Name & Middle Initial & Last Name or Official Title & Degree
Miaoyan Chen
Phone
+86 0756 7263999
Email
chenmiaoyan@trinomab.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahad Sabet, MD
Organizational Affiliation
ICON plc
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICON, plc
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahad Sabet, MD
Phone
801-269-8200
Email
Ahad.Sabet@iconplc.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Profile of TNM005 in Healthy Adult Subjectsy

We'll reach out to this number within 24 hrs