Healthy Subjects (HS)Phase 1NCT07169240
Evaluation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BT-114143 Injection in Healthy Subjects
A Phase 1 study testing BT-114143 in people with Healthy Subjects (HS), run by ScinnoHub Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is a single-center, randomized, double-blind, placebo-controlled, single dose escalation design to evaluate the safety, tolerability, and pharmacokinetic characteristics of BT-114143 Injection. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects (HS)
- What is being tested?
- BT-114143
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 6 Feb 2023to 2 Aug 2025
- 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
- Subjects have been informed of the details of this study before the trial, have signed a written informed consent form, and voluntarily participate in the study;
- Healthy female or male subjects aged 18-55 years (inclusive) at the time of screening;
- Male subjects with a body weight of ≥50.0 kg and female subjects with a body weight of ≥45.0 kg; body mass index (BMI) ranging from 18.5 to 28 kg/m² (inclusive) [BMI = weight (kg) / height² (m²)];
- No history of abnormal eye color vision, or diseases related to the heart, liver, kidney, digestive system, nervous system, mental disorders, metabolic disorders, or blood system; those whose evaluations in terms of medical history, physical examination, vital signs, chest X-ray (posteroanterior), abdominal color Doppler ultrasound, ECG, and laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function, etc.) are normal or show mild abnormalities with no clinical significance, and are deemed eligible by the researcher.
Who cannot join
- Confirmed as COVID-19 patients or asymptomatic infected persons upon inquiry;
- Subjects who have undergone major surgery within 6 months prior to screening, or plan to undergo surgery during the study, as well as those who have previously undergone surgeries that may affect drug absorption, distribution, metabolism, or excretion (excluding appendectomy);
- Subjects with a history of or persistent arterial or venous thrombosis, or at high risk of thrombosis; those with a family history of hereditary coagulation or bleeding disorders;
- Subjects with a history of epilepsy;
- Female subjects with a history of recurrent spontaneous abortion;
- Subjects with positive hepatitis B surface antigen and/or hepatitis B e antigen, positive hepatitis C virus antibody, positive human immunodeficiency virus antibody, or positive treponema pallidum antibody;
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- Subjects with a positive alcohol breath test or positive urine drug abuse screening;
- Heavy drinkers, i.e., consuming more than 14 standard units of alcohol per week within 3 months prior to screening (1 standard unit contains 14 g of alcohol, such as 360 mL of beer, 45 mL of spirits with 40% alcohol content, or 150 mL of wine);
- Subjects with a history of drug abuse (e.g., morphine, tetrahydrocannabinolic acid, methamphetamine, 3,4-methylenedioxymethamphetamine, ketamine) within 1 year prior to the trial;
- Subjects who need to take non-steroidal anti-inflammatory drugs, TXA, or blood-activating Chinese medicines (such as Panax notoginseng, Ligusticum chuanxiong, Salvia miltiorrhiza, etc.) within 1 month prior to enrollment or during the enrollment period;
- Pregnant or lactating women, or those with positive blood pregnancy test results, as well as subjects who do not agree to take effective contraceptive measures from the signing of the informed consent form until 3 months after the end of the study (see Appendix 10.1.7);
- Subjects who participated in other clinical trials and used investigational drugs within 3 months prior to the trial;
- Subjects who donated blood or lost ≥400 mL of blood within 3 months prior to the trial, or plan to donate blood or have blood components drawn during the study;
- Subjects with artificial materials in the body, such as heart valves, implants, etc., which are judged by the researcher as unsuitable for enrollment;
- Subjects with contraindications or potential risk factors for the use of TXA, including those known to be sensitive to TXA;
- Subjects who are judged by the researcher to have poor compliance, or have other factors that make them unsuitable for participating in this trial;
- Subjects who cannot complete the trial for other reasons.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a single-center, randomized, double-blind, placebo-controlled, single dose escalation design to evaluate the safety, tolerability, and pharmacokinetic characteristics of BT-114143 Injection.
- Conditions
- Healthy Subjects (HS)
- Being tested
- BT-114143, 0.9% Sodium Chloride Injection as Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BT-114143Drug
6 subjects will receive a single dose of BT-114143 injection at 0.03 mg/kg.
BT-114143Drug
6 subjects will receive a single dose of BT-114143 injection at 0.07 mg/kg.
BT-114143Drug
3 subjects will receive a single dose of BT-114143 injection at 0.15 mg/kg.
BT-114143Drug
6 subjects will receive a single dose of BT-114143 injection at 0.3 mg/kg.
BT-114143Drug
6 subjects will receive a single dose of BT-114143 injection at 0.6 mg/kg.
BT-114143Drug
6 subjects will receive a single dose of BT-114143 injection at 1.2 mg/kg.
BT-114143Drug
6 subjects will receive a single dose of BT-114143 injection at 2.4 mg/kg.
BT-114143Drug
6 subjects will receive a single dose of BT-114143 injection at 4.8 mg/kg.
BT-114143Drug
6 subjects will receive a single dose of BT-114143 injection at 8.4 mg/kg.
BT-114143Drug
6 subjects will receive a single dose of BT-114143 injection at 12.6 mg/kg.
BT-114143Drug
6 subjects will receive a single dose of BT-114143 injection at 15 mg/kg.
0.9% Sodium Chloride Injection as PlaceboDrug
Except that the S1 dose group was a pilot study group with 1 subject matched to receive a placebo, all other dose groups were each matched with 2 subjects who received placebo treatment as controls.
| Study group | Role | What they receive |
|---|---|---|
| Dose level S-2 | Experimental | Not described Receives: Drug: BT-114143 |
| Dose level S-1 | Experimental | Not described Receives: Drug: BT-114143 |
| Dose level S1 | Experimental | Not described Receives: Drug: BT-114143 |
| Dose level S2 | Experimental | Not described Receives: Drug: BT-114143 |
| Dose level S3 | Experimental | Not described Receives: Drug: BT-114143 |
| Dose level S4 | Experimental | Not described Receives: Drug: BT-114143 |
| Dose level S5 | Experimental | Not described Receives: Drug: BT-114143 |
| Dose level S6 | Experimental | Not described Receives: Drug: BT-114143 |
| Dose level S7 | Experimental | Not described Receives: Drug: BT-114143 |
| Dose level S8 | Experimental | Not described Receives: Drug: BT-114143 |
| Dose level S9 | Experimental | Not described Receives: Drug: BT-114143 |
| control group | Placebo comparator | Not described Receives: Drug: 0.9% Sodium Chloride Injection as Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of BT-114143
The number of Treatment-Emergent Adverse Events (TEAEs) with a severity of Grade 2 or higher in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Measured: For single administration, the follow-up will last until Day 15 after dosing; for multiple administrations, the follow-up will last until Day 21 after dosing.
Secondary outcomes (13)
Cmax
Maximum Concentration
Measured: 15 days after administration
AUC
Area Under the Concentration-Time Curve
Measured: 15 days after administration
t1/2
Half-Life
Measured: 15 days after administration
CL
Clearance
Measured: 15 days after administration
Vz
Volume of Distribution at Steady State
Measured: 15 days after administration
Changes in Plasminogen Activity Results from Baseline
Blood samples will be collected to determine the changes in plasminogen activation over time.
Measured: 72 hours after administration
Changes in Thromboelastography (TEG) Parameters
Blood samples will be collect at each timepoints and TEG parameter (including R, K, Angle, MA, LY30, and CI values) will be measured to determine coagulation function of each subject.
Measured: 72 hours after administration
Prothrombin Time（PT）
the trend of change in PT from baseline
Measured: 15 days after administration
Activated Partial Thromboplastin Time（APTT）
The change in Activated Partial Thromboplastin Time (APTT) from baseline
Measured: 15 days after administration
International Normalized Ratio（INR）
The change in INR (International Normalized Ratio) from baseline
Measured: 15 days after administration
Fibrinogen（FIB）
The change in FIB (Fibrinogen) from baseline
Measured: 15 days after administration
Thrombin Time（TT）
The change in TT (Thrombin Time) from baseline
Measured: 15 days after administration
D-Dimer
The change in D-Dimer (D-Dimer) from baseline
Measured: 15 days after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start6 Feb 2023
- Primary completion17 Apr 2024
- Study completion2 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Subjects (HS)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- ScinnoHub Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University Care Luzhong Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169240
- Sponsor's protocol ID
- BT-114143-I-001
- Status last verified
- Sep 2025
- First submitted
- 17 Aug 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BT-114143 Injection in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07169240
- Acronym / sponsor ID
- BT-114143-I-001
- Conditions
- Healthy Subjects (HS)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- ScinnoHub Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Peking University Care Luzhong Hospital
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 17 Apr 2024 (actual)
- Study completion
- 2 Aug 2025 (actual)
- First posted
- 11 Sep 2025 (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 study is a single-center, randomized, double-blind, placebo-controlled, single dose escalation design to evaluate the safety, tolerability, and pharmacokinetic characteristics of BT-114143 Injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Dose level S-2 | Experimental | Drug: BT-114143 |
| Dose level S-1 | Experimental | Drug: BT-114143 |
| Dose level S1 | Experimental | Drug: BT-114143 |
| Dose level S2 | Experimental | Drug: BT-114143 |
| Dose level S3 | Experimental | Drug: BT-114143 |
| Dose level S4 | Experimental | Drug: BT-114143 |
| Dose level S5 | Experimental | Drug: BT-114143 |
| Dose level S6 | Experimental | Drug: BT-114143 |
| Dose level S7 | Experimental | Drug: BT-114143 |
| Dose level S8 | Experimental | Drug: BT-114143 |
| Dose level S9 | Experimental | Drug: BT-114143 |
| control group | Placebo comparator | Drug: 0.9% Sodium Chloride Injection as Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects have been informed of the details of this study before the trial, have signed a written informed consent form, and voluntarily participate in the study;
- Healthy female or male subjects aged 18-55 years (inclusive) at the time of screening;
- Male subjects with a body weight of ≥50.0 kg and female subjects with a body weight of ≥45.0 kg; body mass index (BMI) ranging from 18.5 to 28 kg/m² (inclusive) [BMI = weight (kg) / height² (m²)];
- No history of abnormal eye color vision, or diseases related to the heart, liver, kidney, digestive system, nervous system, mental disorders, metabolic disorders, or blood system; those whose evaluations in terms of medical history, physical examination, vital signs, chest X-ray (posteroanterior), abdominal color Doppler ultrasound, ECG, and laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function, etc.) are normal or show mild abnormalities with no clinical significance, and are deemed eligible by the researcher.
Key exclusion criteria (17 listed)
- Confirmed as COVID-19 patients or asymptomatic infected persons upon inquiry;
- Subjects who have undergone major surgery within 6 months prior to screening, or plan to undergo surgery during the study, as well as those who have previously undergone surgeries that may affect drug absorption, distribution, metabolism, or excretion (excluding appendectomy);
- Subjects with a history of or persistent arterial or venous thrombosis, or at high risk of thrombosis; those with a family history of hereditary coagulation or bleeding disorders;
- Subjects with a history of epilepsy;
- Female subjects with a history of recurrent spontaneous abortion;
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 |
|---|---|---|
| BT-1141436 subjects will receive a single dose of BT-114143 injection at 0.03 mg/kg. | Drug | Dose level S-1 |
| BT-1141436 subjects will receive a single dose of BT-114143 injection at 0.07 mg/kg. | Drug | Dose level S-2 |
| BT-1141433 subjects will receive a single dose of BT-114143 injection at 0.15 mg/kg. | Drug | Dose level S1 |
| BT-1141436 subjects will receive a single dose of BT-114143 injection at 0.3 mg/kg. | Drug | Dose level S2 |
| BT-1141436 subjects will receive a single dose of BT-114143 injection at 0.6 mg/kg. | Drug | Dose level S3 |
| BT-1141436 subjects will receive a single dose of BT-114143 injection at 1.2 mg/kg. | Drug | Dose level S4 |
| BT-1141436 subjects will receive a single dose of BT-114143 injection at 2.4 mg/kg. | Drug | Dose level S5 |
| BT-1141436 subjects will receive a single dose of BT-114143 injection at 4.8 mg/kg. | Drug | Dose level S6 |
| BT-1141436 subjects will receive a single dose of BT-114143 injection at 8.4 mg/kg. | Drug | Dose level S7 |
| BT-1141436 subjects will receive a single dose of BT-114143 injection at 12.6 mg/kg. | Drug | Dose level S8 |
| BT-1141436 subjects will receive a single dose of BT-114143 injection at 15 mg/kg. | Drug | Dose level S9 |
| 0.9% Sodium Chloride Injection as PlaceboExcept that the S1 dose group was a pilot study group with 1 subject matched to receive a placebo, all other dose groups were each matched with 2 subjects who received placebo treatment as controls. | Drug | control group |
Primary outcome
Safety and tolerability of BT-114143
Time frame: For single administration, the follow-up will last until Day 15 after dosing; for multiple administrations, the follow-up will last until Day 21 after dosing.
The number of Treatment-Emergent Adverse Events (TEAEs) with a severity of Grade 2 or higher in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
13 secondary outcomes
Cmax
Time frame: 15 days after administration
AUC
Time frame: 15 days after administration
t1/2
Time frame: 15 days after administration
CL
Time frame: 15 days after administration
Vz
Time frame: 15 days after administration
Changes in Plasminogen Activity Results from Baseline
Time frame: 72 hours after administration
Changes in Thromboelastography (TEG) Parameters
Time frame: 72 hours after administration
Prothrombin Time（PT）
Time frame: 15 days after administration
Activated Partial Thromboplastin Time（APTT）
Time frame: 15 days after administration
International Normalized Ratio（INR）
Time frame: 15 days after administration
Fibrinogen（FIB）
Time frame: 15 days after administration
Thrombin Time（TT）
Time frame: 15 days after administration
D-Dimer
Time frame: 15 days after administration
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 11 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
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 BT-114143 in people with Healthy Subjects (HS), run by ScinnoHub Pharmaceutical 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 4 inclusion and 17 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 11 Sep 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. 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 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?
Safety and tolerability of BT-114143 (time frame: For single administration, the follow-up will last until Day 15 after dosing; for multiple administrations, the follow-up will last until Day 21 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 11 Sep 2025.