HealthyPhase 1NCT06285201
Study of Felzartamab in Healthy Adult Subjects
A Phase 1 study testing T and R in people with Healthy, run by TJ Biopharma Co., Ltd. at 1 site in China.
Trial summary
A Phase 1 Clinical Study to Evaluate the Pharmacokinetic Comparability, Safety, Tolerability, and Immunogenicity of Felzartamab for Injection Pre- and Post-changes of Process in Healthy Male Adult Subjects in China (Randomized, Double-blind, Single-dose, Two-formulation, Two-sequence, Two-period Crossover Design) Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- T and R
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2024to 15 Aug 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subjects aged ≥ 18 years and ≤ 50 years when signing the ICF.
- Weight ≥ 50 kg and ≤ 80 kg, with a BMI ≥ 19.0 and ≤ 28.0 kg/m2 (inclusive).
- The study doctor determines that the overall health status of the subject is good (normal or abnormal but not clinically significant) based on the subject's medical history, physical examinations, vital signs, ECG, and laboratory test results.
- Subjects who are voluntarily participate in the study, and can understand and sign the ICF.
- Subjects (including their partners) who have no plans for pregnancy or sperm donation during the study and within 6 months after the last dose, and voluntarily use effective contraceptive measures. Specific contraceptive measures are described in Appendix 4.
Who cannot join
- Subjects with diseases that may affect his safety or the results of the study, including but not limited to cardiovascular, respiratory, endocrine, metabolic, renal, hepatic, gastrointestinal, dermatological, infectious, malignant tumors, hematological, skeletal, genitourinary, neurological/psychiatric diseases, and are clinically significant in the opinion of the investigator.
- Subjects who have had acute, chronic, or potential infectious diseases within 1 month pre-dose.
- Subjects with known immune system diseases (such as autoimmune diseases or immunodeficiency diseases), including but not limited to autoimmune hemolytic anemia, etc.
- Subjects who have had a single episode of herpes zoster (shingles) involving the skin or central nervous system within the 6 months pre-dose.
- Subjects who currently have or have a history of multiple episodes of herpes zoster involving the skin or central nervous system.
- Subjects with chronic diarrhea or enteritis within 1 year pre-dose.
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- Subjects with positive result for blood group antibody screening (IAT).
- Subjects who have received monoclonal antibodies, cell therapies within 6 months pre-dose, or have previously received daratumumab or similar drugs, or drugs targeting CD38.
- Subjects who have taken any medicine, including prescription drugs, over-the-counter drugs, and herbal medicine, within two weeks pre-dose.
- Subjects who are suspected or confirmed to be allergic to multiple drugs or foods, including drugs or drug excipients in this clinical study.
- Subjects who have a history of fear of needles or blood, or have difficulty with venous blood collection (have a history of difficulty with blood collection or have corresponding symptoms and signs, and cannot tolerate venous puncture).
- Subjects with the history of blood donation or blood loss of ≥ 200mL in total within 3 months pre-dose;
- Subjects who have participated in any other clinical studies of investigation drug or medical device within the 3 months pre-dose (or 5 half-lives for investigation drugs with so long half-life that the duration of its 5 half- lives is > 3 months).
- Subjects who have undergone major surgery within the last 3 months prior to signing the ICF.
- Subjects who are positive for Hepatitis B (positive for HBsAg or HBcAb and HBV-DNA levels of ≥ 500 cps/mL [or HBV-DNA ≥ 100 IU/mL]), HCV antibodies, HIV antibodies, and anti-TP antibodies.
- Smokers who have smoked more than 5 cigarettes per day in the 3 months prior to the study or who are unable to stop using any tobacco products during the study.
- Subjects who have received attenuated or live viral vaccines (such as Bacille Calmette-Guérin [BCG]) or viral vector vaccines within 12 months before the first dose of investigation drug, or plan to receive within 12 months post-dose.
- Subjects who have received vaccines other than attenuated or live virus vaccines, as well as virus vector vaccines talked above, such as inactivated vaccines, recombinant subunit vaccines, etc. within the 1 month before the first dose.
- The investigator determines the subjects have any other factors that make them unsuitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Clinical Study to Evaluate the Pharmacokinetic Comparability, Safety, Tolerability, and Immunogenicity of Felzartamab for Injection in Healthy Male Adult Subjects in China (Randomized, Double-blind, Crossover Design)
A Phase 1 Clinical Study to Evaluate the Pharmacokinetic Comparability, Safety, Tolerability, and Immunogenicity of Felzartamab for Injection Pre- and Post-changes of Process in Healthy Male Adult Subjects in China (Randomized, Double-blind, Single-dose, Two-formulation, Two-sequence, Two-period Crossover Design)
- Conditions
- Healthy
- Being tested
- T, R
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDrug
8 mg/kg IV of Test drug manufactured by I-Mab Biopharma(Hangzhou)
RDrug
8 mg/kg IV of Test drug manufactured by Patheon Italia
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | T-R Receives: Drug: T; Drug: R |
| Group B | Experimental | R-T Receives: Drug: T; Drug: R |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary PK Endpoint
AUC0-∞
Measured: 36 days after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start27 Mar 2024
- Primary completion15 Aug 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- TJ Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaojiao Li, Doctor, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285201
- Sponsor's protocol ID
- TJ202001BE104
- Status last verified
- Aug 2025
- First submitted
- 22 Feb 2024
- Last updated
- 28 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study to Evaluate the Pharmacokinetic Comparability, Safety, Tolerability, and Immunogenicity of Felzartamab for Injection in Healthy Male Adult Subjects in China (Randomized, Double-blind, Crossover Design)
- ClinicalTrials.gov ID
- NCT06285201
- Acronym / sponsor ID
- TJ202001BE104
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- TJ Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 29 Feb 2024 (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.
A Phase 1 Clinical Study to Evaluate the Pharmacokinetic Comparability, Safety, Tolerability, and Immunogenicity of Felzartamab for Injection Pre- and Post-changes of Process in Healthy Male Adult Subjects in China (Randomized, Double-blind, Single-dose, Two-formulation, Two-sequence, Two-period Crossover Design)
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: T, Drug: RT-R |
| Group B | Experimental | Drug: T, Drug: RR-T |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male subjects aged ≥ 18 years and ≤ 50 years when signing the ICF.
- Weight ≥ 50 kg and ≤ 80 kg, with a BMI ≥ 19.0 and ≤ 28.0 kg/m2 (inclusive).
- The study doctor determines that the overall health status of the subject is good (normal or abnormal but not clinically significant) based on the subject's medical history, physical examinations, vital signs, ECG, and laboratory test results.
- Subjects who are voluntarily participate in the study, and can understand and sign the ICF.
- Subjects (including their partners) who have no plans for pregnancy or sperm donation during the study and within 6 months after the last dose, and voluntarily use effective contraceptive measures. Specific contraceptive measures are described in Appendix 4.
Key exclusion criteria (19 listed)
- Subjects with diseases that may affect his safety or the results of the study, including but not limited to cardiovascular, respiratory, endocrine, metabolic, renal, hepatic, gastrointestinal, dermatological, infectious, malignant tumors, hematological, skeletal, genitourinary, neurological/psychiatric diseases, and are clinically significant in the opinion of the investigator.
- Subjects who have had acute, chronic, or potential infectious diseases within 1 month pre-dose.
- Subjects with known immune system diseases (such as autoimmune diseases or immunodeficiency diseases), including but not limited to autoimmune hemolytic anemia, etc.
- Subjects who have had a single episode of herpes zoster (shingles) involving the skin or central nervous system within the 6 months pre-dose.
- Subjects who currently have or have a history of multiple episodes of herpes zoster involving the skin or central nervous system.
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 |
|---|---|---|
| T8 mg/kg IV of Test drug manufactured by I-Mab Biopharma(Hangzhou) | Drug | Group A, Group B |
| R8 mg/kg IV of Test drug manufactured by Patheon Italia | Drug | Group A, Group B |
Primary outcome
Primary PK Endpoint
Time frame: 36 days after dosing
AUC0-∞
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 Aug 2025.
- 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.
Xiaojiao Li, Doctor principal investigator
The First Hospital of Jilin University
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 T and R in people with Healthy, run by TJ Biopharma Co., Ltd. at 1 site 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 5 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: finished, as of the sponsor's last update on 28 Aug 2025. 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 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. 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?
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?
Primary PK Endpoint (time frame: 36 days after dosing). 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 Aug 2025.