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

NCT06068608 | Unknown Phase 1 FDA Drug

• 1 other identifier: TNM005-101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Varicella

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (10)

• AUC0-t

  Up to 120 days post dosing

• AUC0-∞

  Up to 120 days post dosing

• Cmax

  Up to 120days post dosing

• Tmax

  Up to 120 days post dosing

• t1/2

  Up to 120days post dosing

Study Arms (6)

TNM005 dose level 1/placebo

EXPERIMENTAL

TNM005 on dose level 1 /placebo

Drug: TNM005; Drug: Placebo

TNM005 dose level 2/placebo

EXPERIMENTAL

TNM005 on different dose level 2 /placebo

Drug: TNM005; Drug: Placebo

TNM005 level 3/placebo

EXPERIMENTAL

TNM005 on dose level 3 /placebo

Drug: TNM005; Drug: Placebo

TNM005 dose level 4/placebo

EXPERIMENTAL

TNM005 on dose level 4 /placebo

Drug: TNM005; Drug: Placebo

TNM005 dose level 5/placebo

EXPERIMENTAL

TNM005 on dose level 5 /placebo

Drug: TNM005; Drug: Placebo

VARIZIG

ACTIVE COMPARATOR

VARIZIG 625 IU

Drug: VariZIG

Interventions

TNM005 DRUG

single,intramuscular injection

TNM005 dose level 1/placebo; TNM005 dose level 2/placebo; TNM005 dose level 4/placebo; TNM005 dose level 5/placebo; TNM005 level 3/placebo

Placebo DRUG

single,intramuscular injection

TNM005 dose level 1/placebo; TNM005 dose level 2/placebo; TNM005 dose level 4/placebo; TNM005 dose level 5/placebo; TNM005 level 3/placebo

VariZIG DRUG

a single dose of VARIZIG 625 IU,intramuscular injection

VARIZIG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \) Signed and dated written informed consent;
• \) Are willing and able to comply with scheduled visits, blood sampling, laboratory tests, and other study procedures;
• \) 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;
• \) Have no clinically significant abnormality on physical examination, vital signs, 12-lead ECG, and clinical laboratory tests as determined by the Investigator;
• \) 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.

You may not qualify if:

• \) 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;
• \) History of surgery (except minor outpatient surgery) within three months prior to screening or planned surgery during the study;
• \) History of receiving monoclonal antibody, immunoglobulin, or blood products within six months prior to dosing;
• \) Receipt of systemic immunosuppressive medications;
• \) Exposure to any live attenuated vaccine within four weeks prior to drug administration;
• \) History of receiving vaccine(s) against zoster;
• \) 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;
• \) 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;
• \) 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;
• \) 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;
• \) 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;
• \) 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;
• \) History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein;
• \) History of allergic or anaphylactic reaction to blood products (only for VARIZIG cohort);
• \) IgA deficient subjects at risk for hypersensitivity reaction (only for VARIZIG cohort);

Sponsors & Collaborators

• Zhuhai Trinomab Pharmaceutical Co., Ltd.: lead

Study Sites (1)

ICON, plc

Salt Lake City, Utah, 84124, United States

RECRUITING

MeSH Terms

Conditions

Chickenpox

Interventions

varicella-zoster immune globulin

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Ahad Sabet, MD

  ICON plc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Wang

CONTACT

+86 0756 7263999; emma.wang@trinomab.com

Miaoyan Chen

CONTACT

+86 0756 7263999; chenmiaoyan@trinomab.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2023
• First Posted: October 5, 2023
• Study Start: September 12, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 11, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)