VaricellaPhase 1NCT06068608
A Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Profile of TNM005 in Healthy Adult Subjectsy
A Phase 1 study testing TNM005 and VariZIG in people with Varicella, run by Zhuhai Trinomab Pharmaceutical Co., Ltd. at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Varicella
- What is being tested?
- TNM005 and VariZIG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2023to 31 Dec 2024
- Phase
- Phase 1
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
ICON, plc
Salt Lake City, Utah, 84124
Ahad Sabet, MD, 801-269-8200, Ahad.Sabet@iconplc.com
About this study
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
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
Read the 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.
- Conditions
- Varicella
- Being tested
- TNM005, Placebo, VariZIG
- Medical subject headings
- Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNM005Drug
single,intramuscular injection
PlaceboDrug
single,intramuscular injection
VariZIGDrug
a single dose of VARIZIG 625 IU,intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| TNM005 dose level 1/placebo | Experimental | TNM005 on dose level 1 /placebo Receives: Drug: TNM005; Drug: Placebo |
| TNM005 dose level 2/placebo | Experimental | TNM005 on different dose level 2 /placebo Receives: Drug: TNM005; Drug: Placebo |
| TNM005 level 3/placebo | Experimental | TNM005 on dose level 3 /placebo Receives: Drug: TNM005; Drug: Placebo |
| TNM005 dose level 4/placebo | Experimental | TNM005 on dose level 4 /placebo Receives: Drug: TNM005; Drug: Placebo |
| TNM005 dose level 5/placebo | Experimental | TNM005 on dose level 5 /placebo Receives: Drug: TNM005; Drug: Placebo |
| VARIZIG | Active comparator | VARIZIG 625 IU Receives: Drug: VariZIG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 120 days post dosing
Number of participants with abnormalities of clinical laboratory tests
Clinical laboratory tests include hematology, biochemistry, coagulation, and urinalysis.
Measured: Up to 120 days post dosing
Secondary outcomes (10)
AUC0-t
Area under the plasma concentration-time curve from time 0 (predose) to the last time point with a detectable plasma concentration (Tlast.).
Measured: Up to 120 days post dosing
AUC0-∞
Area under the plasma concentration-time curve from time 0 (predose) extrapolated to infinite time.
Measured: Up to 120 days post dosing
Cmax
Maximum plasma concentration
Measured: Up to 120days post dosing
Tmax
Time to reach maximum plasma concentration
Measured: Up to 120 days post dosing
t1/2
Elimination half-life
Measured: Up to 120days post dosing
λz
Terminal disposition rate constant
Measured: Up to 120days post dosing
CL/F
Apparent clearance
Measured: Up to 120days post dosing
Vd/F
Apparent volume of distribution
Measured: 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
Measured: Up to 120days post dosing
ADA
Incidence of anti-drug antibody (ADA) to TNM005 in serum
Measured: Up to 120days post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start12 Sep 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaricellaStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahad Sabet, MD, Principal investigator, ICON plc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068608
- Sponsor's protocol ID
- TNM005-101
- Status last verified
- Sep 2023
- First submitted
- 16 Sep 2023
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06068608
- Acronym / sponsor ID
- TNM005-101
- Conditions
- Varicella
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Oct 2023 (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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| TNM005 dose level 1/placebo | Experimental | Drug: TNM005, Drug: PlaceboTNM005 on dose level 1 /placebo |
| TNM005 dose level 2/placebo | Experimental | Drug: TNM005, Drug: PlaceboTNM005 on different dose level 2 /placebo |
| TNM005 level 3/placebo | Experimental | Drug: TNM005, Drug: PlaceboTNM005 on dose level 3 /placebo |
| TNM005 dose level 4/placebo | Experimental | Drug: TNM005, Drug: PlaceboTNM005 on dose level 4 /placebo |
| TNM005 dose level 5/placebo | Experimental | Drug: TNM005, Drug: PlaceboTNM005 on dose level 5 /placebo |
| VARIZIG | Active comparator | Drug: VariZIGVARIZIG 625 IU |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (19 listed)
- 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;
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 |
|---|---|---|
| TNM005single,intramuscular injection | Drug | TNM005 dose level 1/placebo, TNM005 dose level 2/placebo, TNM005 dose level 4/placebo, TNM005 dose level 5/placebo, TNM005 level 3/placebo |
| Placebosingle,intramuscular injection | Drug | TNM005 dose level 1/placebo, TNM005 dose level 2/placebo, TNM005 dose level 4/placebo, TNM005 dose level 5/placebo, TNM005 level 3/placebo |
| VariZIGa single dose of VARIZIG 625 IU,intramuscular injection | Drug | VARIZIG |
Primary outcome
Incidence of AEs
Time frame: Up to 120 days post dosing
Number of participants Physical examinations abnormalities
Time frame: Up to 120 days post dosing
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
Time frame: Up to 120 days post dosing
Vital signs measured include blood pressure, pulse rate, temperature, and respiration rate.
Number of participants with abnormalities of 12-lead electrocardiogram (ECG) parameters
Time frame: Up to 120 days post dosing
ECG parameters include heart rate, PR interval, RR interval, ORS duration, QTcF interval.
Number of participants with abnormalities of clinical laboratory tests
Time frame: Up to 120 days post dosing
Clinical laboratory tests include hematology, biochemistry, coagulation, and urinalysis.
10 secondary outcomes
AUC0-t
Time frame: Up to 120 days post dosing
AUC0-∞
Time frame: Up to 120 days post dosing
Cmax
Time frame: Up to 120days post dosing
Tmax
Time frame: Up to 120 days post dosing
t1/2
Time frame: Up to 120days post dosing
λz
Time frame: Up to 120days post dosing
CL/F
Time frame: Up to 120days post dosing
Vd/F
Time frame: Up to 120days post dosing
t1/2 of anti-varicella-zoster virus (VZV) antibody level (both baseline corrected and uncorrected)
Time frame: Up to 120days post dosing
ADA
Time frame: Up to 120days post dosing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Ahad Sabet, MD principal investigator
ICON plc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TNM005 and VariZIG in people with Varicella, run by Zhuhai Trinomab Pharmaceutical Co., Ltd. at 1 site in United States.
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 6 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Wang (+86 0756 7263999, emma.wang@trinomab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AEs (time frame: Up to 120 days post dosing). The study lists 5 primary outcomes in all. 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 11 Jul 2024.