Healthy MenPhase 1NCT05865574
A Comparative Pharmacokinetic Study to Evaluate Different Manufacturing Batches of BAT1706 Injection
A Phase 1 study testing BAT1706 Injection in people with Healthy Men, run by Bio-Thera Solutions at 1 site in China.
Trial summary
This is a randomized, double-blind, single-dose, parallel two-arm study to compare the pharmacokinetics, safety, and immunogenicity of BAT1706 Injection from different manufacturing batches (by new process and old process) in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Men
- What is being tested?
- BAT1706 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2023to 3 Jan 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects aged between 18 and 45 years with body mass index (BMI) between 18.0 and 28.0 kg/m2 and body weight between 50 and 100 kg (inclusive);
- Subjects for whom the results of physical examination, vital signs, 12-lead ECG, and laboratory tests are normal or abnormal without clinical significance;
- Subjects who do not smoke, or smoke no more than 5 cigarettes per day for < 10 years;
- Subjects who agree to use effective contraception (including but not limited to: hormonal contraception, physical contraception, or abstinence) from the time of signing the informed consent form until 6 months after intravenous drip of the study drug;
- Subjects who are willing and able to follow the visits, treatments, laboratory tests, and other relevant procedures specified in this study.
Who cannot join
- Subjects who have previous or current clinically significant gastrointestinal disorder (including diverticulitis, gastric ulcer), renal disorder, liver disorder, cardiovascular disorder, hematological disorder, lung disorder, nervous system disorder, metabolic disorder (including known diabetes mellitus), psychosis, or allergic disease (excluding mild asymptomatic seasonal allergy) at screening/enrollment, and in the opinion of the investigator, are not suitable for participation in this clinical study;
- Subjects who have psychiatric disorders, or in the opinion of the investigator, are not suitable for participation in this clinical study (e.g., he is considered unable to understand or follow the relevant requirements of the study, or some of his existing conditions may result in additional risks associated with participation in this study);
- Subjects who have previous or current clinically significant allergies (excluding mild asymptomatic seasonal allergy); or subjects who have known or suspected allergy or hypersensitivity to any component of the study drug; or subjects who have known or suspected hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies;
- Subjects who have a tendency to haemorrhage or thrombosis, or have a history of non-traumatic haemorrhage with appropriate clinical treatment, or have a history of thrombosis, or have any disease that may increase the risk of haemorrhage or thrombosis (e.g., abnormal coagulation, thrombocytopenia, or INR > 1.5);
- Subjects who have any previous malignancy including lymphoma, leukemia, and skin cancer;
- Subjects who have abnormal and clinically significant ECG (as judged by the investigator), or corrected QT interval according to Bazett's formula > 470 ms (Bazett's formula: Q-Tc = QT/(R-R)0.5, where R-R represents the interval between two R waves in s);
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- Subjects who have a history of hypertension, or systolic blood pressure > 145 mmHg or diastolic blood pressure > 95 mmHg at screening/enrollment;
- Subjects who have clinically significant chronic or acute infection at screening/enrollment; or have any positive result for HBV surface antigen, HCV antibody, HIV antibody, and treponema pallidum antibody at screening;
- Subjects who have previously used Bevacizumab or VEGF-targeting agents;
- Subjects who have used any biological product within 3 months prior to enrollment, or have used any monoclonal antibody within 9 months prior to enrollment;
- Subjects who have used prescription or over-the-counter drugs within 14 days prior to enrollment, or less than 5 half-lives have passed from the last dose to the dosing day of this study, whichever is longer;
- Subjects who have used any Chinese herbal medicine within 14 days prior to enrollment;
- Subjects who have participated in other drug clinical trials within 3 months prior to enrollment, or propose to participate in other drug clinical trials during this study;
- Subjects who have received live virus vaccine within 12 weeks prior to screening, or plan to receive live virus vaccine during the study;
- Subjects who have undergone major injury, surgery, or fracture within 4 weeks prior to enrollment, or propose to undergo surgery during the study;
- Subjects who have donated blood or have blood samples > 400 mL collected as subjects within 3 months prior to screening, or plan to donate blood during the study;
- Subjects who have a history of alcohol dependence, or have a positive alcohol test result at screening/baseline;
- Subjects who have consumed alcoholic beverages within 48 h prior to enrollment;
- Subjects who have a history of drug abuse, or have a positive drug abuse test result at screening/baseline;
- Subjects who cannot follow the restrictions on smoking, alcohol consumption and concomitant medications for this study during the study;
- Subjects who cannot stop high-intensity physical activities from the dosing day of the study drug until 30 days post-dose.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui
About this study
Official title: A Randomized, Double-blind, Single-dose, Parallel Two-arm Study to Compare the Pharmacokinetics and Safety of BAT1706 Injection From Different Manufacturing Batches (by New Process and Old Process) in Healthy Subjects
This is a randomized, double-blind, single-dose, parallel two-arm study to compare the pharmacokinetics, safety, and immunogenicity of BAT1706 Injection from different manufacturing batches (by new process and old process) in healthy male subjects.
Read the detailed description
A total of 38 subjects are planned to be enrolled and randomized in a 1: 1 ratio to receive a single intravenous drip of BAT1706 Injection (by old process) or BAT1706 Injection (by new process) at 1 mg/kg body weight.
A 7-day screening period will be set up for this study. Subjects will be admitted to the hospital 1 day pre-dose (Day -1) and discharged after completing relevant observations and assessments 24 h post-dose. After discharge, subjects should return to the hospital for 12 follow-up visits according to the requirements of this study, on Days 3, 4, 5, 8, 11, 15, 22, 29, 36, 43, 57 and 71 post-dose.
- Conditions
- Healthy Men
- Being tested
- BAT1706 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAT1706 InjectionDrug
Also called BAT1706
1 vial/carton, 400 mg/16 mL/vial
| Study group | Role | What they receive |
|---|---|---|
| BAT1706（New Process） | Experimental | Drug: BAT1706
1 mg/kg, the corresponding volume of bulk solution should be drawn according to the actual body weight of the subject, diluted to 100 mL with 0.9% sodium chloride solution, and administered by intravenous drip Receives: Drug: BAT1706 Injection |
| BAT1706（Old Process） | Active comparator | Drug: BAT1706
1 mg/kg, the corresponding volume of bulk solution should be drawn according to the actual body weight of the subject, diluted to 100 mL with 0.9% sodium chloride solution, and administered by intravenous drip Receives: Drug: BAT1706 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-inf
Area under the plasma concentration-time curve from zero to infinity, AUC0-∞ = AUC0-t + Ct/λz
Measured: Day1, 2, 3, 4, 5, 8,15, 22, 29, 36, 43, 57, 71
AUC0-t
Area under the blood concentration-time curve from time 0 to the last time point at which the concentration can be measured
Measured: Day1, 2, 3, 4, 5, 8,15, 22, 29, 36, 43, 57, 71
Cmax
Maximum blood concentration
Measured: Day1, 2, 3, 4, 5, 8,15, 22, 29, 36, 43, 57, 71
Tmax
Observed time to peak concentration
Measured: Day1, 2, 3, 4, 5, 8,15, 22, 29, 36, 43, 57, 71
t1/2
Elimination half-life t1/2 = 0.693/λz
Measured: Day1, 2, 3, 4, 5, 8,15, 22, 29, 36, 43, 57, 71
Secondary outcomes (2)
Adverse events
AE and SAE
Measured: Day1, 2, 3, 4, 5, 8,15, 22, 29, 36, 43, 57, 71
Immunogenicity
Anti-drug antibody (ADA) positivity, ADA titer and neutralizing antibody (NAb) positivity for ADA.
Measured: Day1, 2, 3, 4, 5, 8,15, 22, 29, 36, 43, 57, 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start15 Jun 2023
- Primary completion21 Sep 2023
- Study completion3 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy MenStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Thera Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wei Hu, Ph.D, Principal investigator, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865574
- Sponsor's protocol ID
- BAT-1706-004-CR
- Status last verified
- Sep 2026
- First submitted
- 28 Apr 2023
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Single-dose, Parallel Two-arm Study to Compare the Pharmacokinetics and Safety of BAT1706 Injection From Different Manufacturing Batches (by New Process and Old Process) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05865574
- Acronym / sponsor ID
- BAT-1706-004-CR
- Conditions
- Healthy Men
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Bio-Thera SolutionsIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 21 Sep 2023 (actual)
- Study completion
- 3 Jan 2024 (actual)
- First posted
- 19 May 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.
This is a randomized, double-blind, single-dose, parallel two-arm study to compare the pharmacokinetics, safety, and immunogenicity of BAT1706 Injection from different manufacturing batches (by new process and old process) in healthy male subjects.
Detailed description
A total of 38 subjects are planned to be enrolled and randomized in a 1: 1 ratio to receive a single intravenous drip of BAT1706 Injection (by old process) or BAT1706 Injection (by new process) at 1 mg/kg body weight.
A 7-day screening period will be set up for this study. Subjects will be admitted to the hospital 1 day pre-dose (Day -1) and discharged after completing relevant observations and assessments 24 h post-dose. After discharge, subjects should return to the hospital for 12 follow-up visits according to the requirements of this study, on Days 3, 4, 5, 8, 11, 15, 22, 29, 36, 43, 57 and 71 post-dose.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAT1706（New Process） | Experimental | Drug: BAT1706 InjectionDrug: BAT1706 1 mg/kg, the corresponding volume of bulk solution should be drawn according to the actual body weight of the subject, diluted to 100 mL with 0.9% sodium chloride solution, and administered by intravenous drip |
| BAT1706（Old Process） | Active comparator | Drug: BAT1706 InjectionDrug: BAT1706 1 mg/kg, the corresponding volume of bulk solution should be drawn according to the actual body weight of the subject, diluted to 100 mL with 0.9% sodium chloride solution, and administered by intravenous drip |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male subjects aged between 18 and 45 years with body mass index (BMI) between 18.0 and 28.0 kg/m2 and body weight between 50 and 100 kg (inclusive);
- Subjects for whom the results of physical examination, vital signs, 12-lead ECG, and laboratory tests are normal or abnormal without clinical significance;
- Subjects who do not smoke, or smoke no more than 5 cigarettes per day for < 10 years;
- Subjects who agree to use effective contraception (including but not limited to: hormonal contraception, physical contraception, or abstinence) from the time of signing the informed consent form until 6 months after intravenous drip of the study drug;
- Subjects who are willing and able to follow the visits, treatments, laboratory tests, and other relevant procedures specified in this study.
Key exclusion criteria (21 listed)
- Subjects who have previous or current clinically significant gastrointestinal disorder (including diverticulitis, gastric ulcer), renal disorder, liver disorder, cardiovascular disorder, hematological disorder, lung disorder, nervous system disorder, metabolic disorder (including known diabetes mellitus), psychosis, or allergic disease (excluding mild asymptomatic seasonal allergy) at screening/enrollment, and in the opinion of the investigator, are not suitable for participation in this clinical study;
- Subjects who have psychiatric disorders, or in the opinion of the investigator, are not suitable for participation in this clinical study (e.g., he is considered unable to understand or follow the relevant requirements of the study, or some of his existing conditions may result in additional risks associated with participation in this study);
- Subjects who have previous or current clinically significant allergies (excluding mild asymptomatic seasonal allergy); or subjects who have known or suspected allergy or hypersensitivity to any component of the study drug; or subjects who have known or suspected hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies;
- Subjects who have a tendency to haemorrhage or thrombosis, or have a history of non-traumatic haemorrhage with appropriate clinical treatment, or have a history of thrombosis, or have any disease that may increase the risk of haemorrhage or thrombosis (e.g., abnormal coagulation, thrombocytopenia, or INR > 1.5);
- Subjects who have any previous malignancy including lymphoma, leukemia, and skin cancer;
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 |
|---|---|---|
| BAT1706 InjectionAlso: BAT17061 vial/carton, 400 mg/16 mL/vial | Drug | BAT1706（New Process）, BAT1706（Old Process） |
Primary outcome
AUC0-inf
Time frame: Day1, 2, 3, 4, 5, 8,15, 22, 29, 36, 43, 57, 71
Area under the plasma concentration-time curve from zero to infinity, AUC0-∞ = AUC0-t + Ct/λz
AUC0-t
Time frame: Day1, 2, 3, 4, 5, 8,15, 22, 29, 36, 43, 57, 71
Area under the blood concentration-time curve from time 0 to the last time point at which the concentration can be measured
Cmax
Time frame: Day1, 2, 3, 4, 5, 8,15, 22, 29, 36, 43, 57, 71
Maximum blood concentration
Tmax
Time frame: Day1, 2, 3, 4, 5, 8,15, 22, 29, 36, 43, 57, 71
Observed time to peak concentration
t1/2
Time frame: Day1, 2, 3, 4, 5, 8,15, 22, 29, 36, 43, 57, 71
Elimination half-life t1/2 = 0.693/λz
2 secondary outcomes
Adverse events
Time frame: Day1, 2, 3, 4, 5, 8,15, 22, 29, 36, 43, 57, 71
Immunogenicity
Time frame: Day1, 2, 3, 4, 5, 8,15, 22, 29, 36, 43, 57, 71
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 1 Oct 2026.
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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.
Wei Hu, Ph.D principal investigator
The Second Hospital of Anhui Medical 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 BAT1706 Injection in people with Healthy Men, run by Bio-Thera Solutions 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 21 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 1 Oct 2026. 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?
AUC0-inf (time frame: Day1, 2, 3, 4, 5, 8,15, 22, 29, 36, 43, 57, 71). 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 1 Oct 2026.