Respiratory Syncytial Virus InfectionsPhase 1/2NCT05630573
A Study of TNM001 in Chinese Healthy Preterm and Term Infants
A Phase 1/2 study testing TNM001 in people with Respiratory Syncytial Virus Infections, run by Zhuhai Trinomab Pharmaceutical Co., Ltd. at 6 sites in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages Up to 1 yearHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- TNM001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 6 sitesChina
- Study dates
- 25 Oct 2022to 30 Jun 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 year
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Hunan Provincial People's Hospital
Changsha, Hunan, 410005
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410006
West China Second University Hospital, Sichuan University
Chengdu, Sichuan, 610041
Linfen People's Hospital
Linfen, Shanxi, 041000
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Yuncheng Central Hospital
Yuncheng, Shanxi, 044099
About this study
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
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
Read the detailed description
This phase Ib/IIa study is designed to assess the safety, tolerability, and pharmacokinetics (PK) profile TNM001 in healthy preterm and term infants. This study will also compare the incidence of Respiratory Syncytial Virus（RSV） infection between different doses of TNM001 and placebo, which will be used to select the dose to be studied in the later phase of clinical trials of TNM001. Approximately 30 subjects will be randomized and will be dosed once on Day 1 and followed up until Day 151. Around 6 investigational study centres participate in the study.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- TNM001, Placebo
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNM001Biological
intramuscular injection
PlaceboBiological
intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| TNM001 Injection dose 1 | Experimental | low dose administered Receives: Biological: TNM001 |
| TNM001 Injection dose 2 | Experimental | medium dose administered Receives: Biological: TNM001 |
| TNM001 Injection dose 3 | Experimental | high dose administered Receives: Biological: TNM001 |
| placebo | Placebo comparator | placebo administered Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of TNM001 Injection
Type and incidence of adverse events and serious adverse events
Measured: 150 days post dose
Secondary outcomes (5)
Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of TNM001
The pharmacokinetic (PK) parameter AUC (0-infinity) will be estimated based on the serum concentrations of TNM001
Measured: 150 days post dose
Maximum Observed Serum Concentration (Cmax) of TNM001
The Cmax is the maximum observed serum concentration of TNM001
Measured: 150 days post dose
Terminal Elimination Half Life (t1/2) of TNM001
Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the serum
Measured: 150 days post dose
Serum anti-RSV neutralizing antibodies titer levels in each dose cohort
To summarize the proportion of subjects with severalfold increase after dosing compared to the predose (baseline)
Measured: 150 days post dose
Anti-drug antibody (ADA) positive rate of TNM001
The evaluation indicator of immunogenicity is the ADA positive rate in subjects
Measured: 150 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start25 Oct 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hanmin Liu, Principal investigator, West China Second Hospital, Sichuan UniversityQin Yu, Principal investigator, West China Second Hospital, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630573
- Sponsor's protocol ID
- TNM001-201
- Status last verified
- Jun 2024
- First submitted
- 9 Nov 2022
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05630573
- Acronym / sponsor ID
- TNM001-201
- Conditions
- Respiratory Syncytial Virus Infections
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This phase Ib/IIa study is designed to assess the safety, tolerability, and pharmacokinetics (PK) profile TNM001 in healthy preterm and term infants. This study will also compare the incidence of Respiratory Syncytial Virus（RSV） infection between different doses of TNM001 and placebo, which will be used to select the dose to be studied in the later phase of clinical trials of TNM001. Approximately 30 subjects will be randomized and will be dosed once on Day 1 and followed up until Day 151. Around 6 investigational study centres participate in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TNM001 Injection dose 1 | Experimental | Biological: TNM001low dose administered |
| TNM001 Injection dose 2 | Experimental | Biological: TNM001medium dose administered |
| TNM001 Injection dose 3 | Experimental | Biological: TNM001high dose administered |
| placebo | Placebo comparator | Biological: Placeboplacebo administered |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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 (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNM001intramuscular injection | Biological | TNM001 Injection dose 1, TNM001 Injection dose 2, TNM001 Injection dose 3 |
| Placebointramuscular injection | Biological | placebo |
Primary outcome
Safety and tolerability of TNM001 Injection
Time frame: 150 days post dose
Type and incidence of adverse events and serious adverse events
5 secondary outcomes
Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of TNM001
Time frame: 150 days post dose
Maximum Observed Serum Concentration (Cmax) of TNM001
Time frame: 150 days post dose
Terminal Elimination Half Life (t1/2) of TNM001
Time frame: 150 days post dose
Serum anti-RSV neutralizing antibodies titer levels in each dose cohort
Time frame: 150 days post dose
Anti-drug antibody (ADA) positive rate of TNM001
Time frame: 150 days post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanmin Liu principal investigator
West China Second Hospital, Sichuan University
Qin Yu principal investigator
West China Second Hospital, Sichuan University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TNM001 in people with Respiratory Syncytial Virus Infections, run by Zhuhai Trinomab Pharmaceutical Co., Ltd. at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of TNM001 Injection (time frame: 150 days post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.