A Study of TNM001 in Chinese Healthy Preterm and Term Infants
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ClinicalTrials.gov Identifier: NCT05630573 |
Recruitment Status :
Completed
First Posted : November 29, 2022
Last Update Posted : June 21, 2024
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The purpose of this clinical trial is to evaluate the safety, tolerability and pharmacokinetics (PK) profile of TNM001 injection in healthy preterm and term infants. The main questions it aims to answer are:
- the safety and tolerability of TNM001 injection
- the pharmacokinetic (PK) profile of TNM001
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Respiratory Syncytial Virus Infections | Biological: TNM001 Biological: Placebo | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 31 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase Ib/IIa Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of TNM001 Injection in Chinese Healthy Preterm and Term Infants |
Actual Study Start Date : | October 25, 2022 |
Actual Primary Completion Date : | June 30, 2023 |
Actual Study Completion Date : | June 30, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: TNM001 Injection dose 1 or placebo
low dose administered
|
Biological: TNM001
intramuscular injection Biological: Placebo intramuscular injection |
Experimental: TNM001 Injection dose 2 or placebo
medium dose administered
|
Biological: TNM001
intramuscular injection Biological: Placebo intramuscular injection |
Experimental: TNM001 Injection dose 3 or placebo
high dose administered
|
Biological: TNM001
intramuscular injection Biological: Placebo intramuscular injection |
- Safety and tolerability of TNM001 Injection [ Time Frame: 150 days post dose ]Type and incidence of adverse events and serious adverse events
- Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of TNM001 [ Time Frame: 150 days post dose ]The pharmacokinetic (PK) parameter AUC (0-infinity) will be estimated based on the serum concentrations of TNM001
- Maximum Observed Serum Concentration (Cmax) of TNM001 [ Time Frame: 150 days post dose ]The Cmax is the maximum observed serum concentration of TNM001
- Terminal Elimination Half Life (t1/2) of TNM001 [ Time Frame: 150 days post dose ]Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the serum
- Serum anti-RSV neutralizing antibodies titer levels in each dose cohort [ Time Frame: 150 days post dose ]To summarize the proportion of subjects with severalfold increase after dosing compared to the predose (baseline)
- Anti-drug antibody (ADA) positive rate of TNM001 [ Time Frame: 150 days post dose ]The evaluation indicator of immunogenicity is the ADA positive rate in subjects
- Lower respiratory tract infection(LRTI) [ Time Frame: 150 days post dose ]The incidence of LRTI
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Ages Eligible for Study: | up to 1 Year (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Key Inclusion Criteria:
- Healthy preterm infants and term infants within 1 year old of age
- Infants who are in the first RSV infection season at the time of randomization
Key Exclusion Criteria:
- Any fever or acute illness within 7 days prior to dosing
- LRTI prior to randomization
- Received any anti-RSV monoclonal antibody or RSV vaccine
- Any other circumstances that, in the opinion of the investigator, may interfere with the assessment of the study drug or the interpretation of the study results
- The subject is a child of the investigator or his/her subordinate study personnel or relatives or sponsor staff
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05630573
China, Hebei | |
The Second Hospital of Hebei Medical University | |
Shijiazhuang, Hebei, China, 050000 | |
China, Hunan | |
Hunan Provincial People's Hospital | |
Changsha, Hunan, China, 410005 | |
The Third Xiangya Hospital of Central South University | |
Changsha, Hunan, China, 410006 | |
China, Shanxi | |
Linfen People's Hospital | |
Linfen, Shanxi, China, 041000 | |
Yuncheng Central Hospital | |
Yuncheng, Shanxi, China, 044099 | |
China, Sichuan | |
West China Second University Hospital, Sichuan University | |
Chengdu, Sichuan, China, 610041 |
Principal Investigator: | Hanmin Liu | West China Second Hospital, Sichuan University | |
Principal Investigator: | Qin Yu | West China Second Hospital, Sichuan University |
Responsible Party: | Zhuhai Trinomab Pharmaceutical Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT05630573 |
Other Study ID Numbers: |
TNM001-201 |
First Posted: | November 29, 2022 Key Record Dates |
Last Update Posted: | June 21, 2024 |
Last Verified: | June 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Respiratory Syncytial Virus Infections Virus Diseases Infections Pneumovirus Infections |
Paramyxoviridae Infections Mononegavirales Infections RNA Virus Infections |