Venous ThrombosisPhase 1NCT04036656
Phase I Study of Direct Coagulation Factor Xa Inhibitor SYHA136 Tablets in Chinese Healthy Volunteers
A Phase 1 study testing SYHA136 0.5 mg, SYHA136 1 mg and SYHA136 2.5 mg in people with Venous Thrombosis, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
Trial summary
The trial used single-center, randomized, double-blind, placebo-controlled, single-dose ascending study. The trial planned to enroll fifty-six healthy volunteers. The subjects were allocated to eight dose groups, including 0.5 mg (3+1), 1 mg (3+1), 2.5 mg (6+2), 5 mg (6+2), 10 mg (6+2), 20 mg (6+2), 35 mg(6+2) and 50… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Venous Thrombosis
- What is being tested?
- SYHA136 0.5 mg, SYHA136 1 mg and SYHA136 2.5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Aug 2019to May 2020
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- When subject signs the informed contest, 18≤ age ≤ 40, Male or female;
- Body weight: male ≥50 kg, female ≥45 kg. Body mass index (BMI) of 19.0 to 26.0 kg/m², inclusive;
- Subject's with normal or or abnormity without clinical significance judged by the investigator by physical examination, vital signs, electrocardiogram, blood routine, blood biochemistry, coagulation tests, fecal occult blood, urine routine, serological tests and other important indicators;
- All subjects who adopt effective non-hormonal contraceptive measures (such as condoms, intrauterine devices without drugs, etc.) from the signing of informed consent to three months after the end of the study;
- Subjects who voluntarily signed the informed consent and are able to cooperate to complete the test according to the protocal.
Who cannot join
- Allergic history to more than one drug or other serious allergic rhistory;
- Serious diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders or other diseases (such as history of psychosis, malignant tumors, etc.)In the past or now, which were not suitable for clinical trials.
- History of abnormal bleeding or coagulation disorders (e.g. prone to bruising, gum bleeding, prolonged bleeding after tooth extraction, joint hemorrhage, menorrhagia, postpartum hemorrhage, vitamin K deficiency, haemorrhagic diseases caused by acquired coagulation factor antibodies, trauma, wound or post-operative bleeding, etc.);
- History of severe head trauma in 2 years;
- Severe gastrointestinal diseases occurred within three months before signing informed consent, which affected drug absorption;
- Have a disease which Haemorrhage could cause serious consequences, such as peptic ulcer;
Show all 19Show fewer
- Had undergone surgery within six months before signing the informed consent; planned to undergo surgery (including cosmetic surgery, dental surgery and oral surgery) within two weeks after the end of the trial; or planned to take part in vigorous exercise (including physical contact exercise or collision exercise) during the trial;
- Bleed or donated more than 400 mL within three months before signing informed consent, or planned to donate blood during the study or within one month after the end of the trial;
- Have taken any prescription drugs, nonpreserip drugs, biological products, traditional Chinese medicines, herbal medicines, vitamin dietary supplements and health products within four weeks before signing the informed consent or use oral long-acting contraceptives or implanted long-acting contraceptives;
- Subjects participating in other clinical trials and taking trial products, or participated in any other clinical trials of drugs within three months before signing the informed consent;
- History of drugs or drug abuse or alcoholics or drug abuse screening shows positive response;
- current or past alcoholics (drinking more than 14 standard units per week, 1 Standard unit containing 14g alcohol, such as 360 mL beer or 40% spirits or 150 mL wines with 45 mL alcohol), or alcohol breath test positive;
- Smokers: The average daily smoking volume was more than 5 cigarettes within six months before signing the informed consent;
- Habitually consume excessive caffeine-containing beverages or foods, or foods that may affect drug metabolism within four weeks before signing informed consent. Such as: coffee (no more than 1100 mL per day), tea (no more than 2200 mL per day), cola (no more than 2200 mL per day), functional drinks (no more than 1100 mL per day), chocolate (no more than 510 g per day);
- Positive with serum immunological test for HBsAg, Anti-HCV, Anti-HIV or Anti-TP;
- QTc interval≥450 ms, electrocardiogram abnormality with clinical significance, or prolonged history of QTc interval;
- Abnormal results of chest X-ray (posterior and anterior) with clinical significance;
- Female subjects: positive pregnancy tests or pregnant or breast-feeding or planning to conceive, who plan to conceive within three months from the signing of informed consent to the end of the study; male subjects: whose partners plan to conceive or plan to donate sperm within three months from the signing of informed consent to the end of the study;
- Not suitable for this trial according to the investigator.
About this study
Official title: Single-center, Randomized, Double-blind, Placebo-controlled, Single Dose Ascending Trial of SYHA 136 Tablets in Healthy Subjects
The trial used single-center, randomized, double-blind, placebo-controlled, single-dose ascending study.
The trial planned to enroll fifty-six healthy volunteers. The subjects were allocated to eight dose groups, including 0.5 mg (3+1), 1 mg (3+1), 2.5 mg (6+2), 5 mg (6+2), 10 mg (6+2), 20 mg (6+2), 35 mg(6+2) and 50 mg (6+2). Each dose group was allocated test drugs and placebos according to the proportion of subjects in the brackets mentioned above.
- Conditions
- Venous Thrombosis
- Being tested
- SYHA136 0.5 mg, SYHA136 1 mg, SYHA136 2.5 mg, SYHA136 5 mg, SYHA136 10 mg
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYHA136 0.5 mgDrug
oral tablet
SYHA136 1 mgDrug
oral tablet
SYHA136 2.5 mgDrug
oral tablet
SYHA136 5 mgDrug
oral tablet
SYHA136 10 mgDrug
oral tablet
SYHA136 20 mgDrug
oral tablet
SYHA136 35 mgDrug
oral tablet
SYHA136 50 mgDrug
oral tablet
Placebo matching SYHA136 0.5 mgDrug
oral tablet
Placebo matching SYHA136 1 mgDrug
oral tablet
Placebo matching SYHA136 2.5 mgDrug
oral tablet
Placebo matching SYHA136 5 mgDrug
oral tablet
Placebo matching SYHA136 10 mgDrug
oral tablet
Placebo matching SYHA136 20 mgDrug
oral tablet
Placebo matching SYHA136 35 mgDrug
oral tablet
Placebo matching SYHA136 50 mgDrug
oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1:SYHA136 0.5 mg or Placebo matching SYHA136 0.5 mg | Experimental | Participants will receive a single oral dose of SYHA136 0.5 mg or Placebo matching SYHA136 0.5 mg under fasted conditions. Receives: Drug: SYHA136 0.5 mg; Drug: Placebo matching SYHA136 0.5 mg |
| Cohort 2:SYHA136 1 mg or Placebo matching SYHA136 1 mg | Experimental | Participants will receive a single oral dose of SYHA136 1 mg or Placebo matching SYHA136 1 mg under fasted conditions. Receives: Drug: SYHA136 1 mg; Drug: Placebo matching SYHA136 1 mg |
| Cohort 3:SYHA136 2.5 mg or Placebo matching SYHA136 2.5 mg | Experimental | Participants will receive a single oral dose of SYHA136 2.5 mg or Placebo matching SYHA136 2.5 mg under fasted conditions. Receives: Drug: SYHA136 2.5 mg; Drug: Placebo matching SYHA136 2.5 mg |
| Cohort 4:SYHA136 5 mg or Placebo matching SYHA136 5 mg | Experimental | Participants will receive a single oral dose of SYHA136 5 mg or Placebo matching SYHA136 5 mg under fasted conditions. Receives: Drug: SYHA136 5 mg; Drug: Placebo matching SYHA136 5 mg |
| Cohort 5:SYHA136 10 mg or Placebo matching SYHA136 10 mg | Experimental | Participants will receive a single oral dose of SYHA136 10 mg or Placebo matching SYHA136 10 mg under fasted conditions. Receives: Drug: SYHA136 10 mg; Drug: Placebo matching SYHA136 10 mg |
| Cohort 6:SYHA136 20 mg or Placebo matching SYHA136 20 mg | Experimental | Participants will receive a single oral dose of SYHA136 20 mg or Placebo matching SYHA136 20 mg under fasted conditions. Receives: Drug: SYHA136 20 mg; Drug: Placebo matching SYHA136 20 mg |
| Cohort 7:SYHA136 35 mg or Placebo matching SYHA136 35 mg | Experimental | Participants will receive a single oral dose of SYHA136 35 mg or Placebo matching SYHA136 35 mg under fasted conditions. Receives: Drug: SYHA136 35 mg; Drug: Placebo matching SYHA136 35 mg |
| Cohort 1:SYHA136 50 mg or Placebo matching SYHA136 50 mg | Experimental | Participants will receive a single oral dose of SYHA136 50 mg or Placebo matching SYHA136 50 mg under fasted conditions. Receives: Drug: SYHA136 50 mg; Drug: Placebo matching SYHA136 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
Number of participants that experience Adverse Events (AEs)
Measured: From Screening period to 12 Days Post dose
Serious Adverse Events (SAEs)
Number of participants that experience Serious Adverse Events (SAEs)
Measured: From Screening period to 12 Days Post dose
clinically significant laboratory assessment abnormalities
Number of participants with clinically significant laboratory assessment abnormalities
Measured: Up to 72 hours Post dose
clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Measured: Up to 72 hours Post dose
clinically significant physical examination abnormalities
Number of participants with clinically significant physical examination abnormalities
Measured: Up to 72 hours Post dose
Secondary outcomes (14)
Area Under the concentration-time curve from time zero to time of the Last Measurable Concentration (AUC0-tlast)
PK Assessment - Area Under the concentration-time curve from time zero to time of the Last Measurable Concentration (AUC0-tlast)
Measured: Up to 72 hours Post dose
Area under the concentration-time curve from time 0 to infinity (AUCinf)
PK Assessment - Area under the concentration-time curve from time 0 to infinity (AUCinf)
Measured: Up to 72 hours Post dose
Maximum observed concentration (Cmax)
PK Assessment - Maximum observed concentration (Cmax)
Measured: Up to 72 hours Post dose
Time to reach maximum observed concentration (Tmax)
PK Assessment - Time to reach maximum observed concentration (Tmax)
Measured: Up to 72 hours Post dose
Terminal elimination half-life (t1/2)
PK Assessment - Terminal elimination half-life (t1/2)
Measured: Up to 72 hours Post dose
Apparent total body clearance (CL/F)
PK Assessment - Apparent total body clearance (CL/F)
Measured: Up to 72 hours Post dose
Apparent volume of distribution (Vz/F)
PK Assessment - Apparent volume of distribution (Vz/F)
Measured: Up to 72 hours Post dose
Amount of SYHA136 excreted in urine (Aeu)
PK Assessment - Amount of SYHA136 excreted in urine (Aeu)
Measured: Up to 72 hours Post dose
Renal clearance (CLr)
PK Assessment - Renal clearance (CLr)
Measured: Up to 72 hours Post dose
Activated Partial Thromboplastin Time(aPTT)
PD Assessment-Activated Partial Thromboplastin Time(aPTT)
Measured: Up to 48 hours Post dose
Fibrinogen(Fbg)
PD Assessment-Fibrinogen(Fbg)
Measured: Up to 48 hours Post dose
Thrombin Time(TT)
PD Assessment-Thrombin Time(TT)
Measured: Up to 48 hours Post dose
International Normalized Ratio(INR)
PD Assessment-International Normalized Ratio(INR)
Measured: Up to 48 hours Post dose
Anti-coagulation Factor Xa assays(AXA)
PD Assessment-Anti-coagulation Factor Xa assays(AXA)
Measured: Up to 48 hours Post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study startAug 2019 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036656
- Sponsor's protocol ID
- SYHA136201901/PRO-I
- Status last verified
- Jul 2019
- First submitted
- 23 Jul 2019
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- 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 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Randomized, Double-blind, Placebo-controlled, Single Dose Ascending Trial of SYHA 136 Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04036656
- Acronym / sponsor ID
- SYHA136201901/PRO-I
- Conditions
- Venous Thrombosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2019 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 30 Jul 2019 (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 trial used single-center, randomized, double-blind, placebo-controlled, single-dose ascending study.
The trial planned to enroll fifty-six healthy volunteers. The subjects were allocated to eight dose groups, including 0.5 mg (3+1), 1 mg (3+1), 2.5 mg (6+2), 5 mg (6+2), 10 mg (6+2), 20 mg (6+2), 35 mg(6+2) and 50 mg (6+2). Each dose group was allocated test drugs and placebos according to the proportion of subjects in the brackets mentioned above.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1:SYHA136 0.5 mg or Placebo matching SYHA136 0.5 mg | Experimental | Drug: SYHA136 0.5 mg, Drug: Placebo matching SYHA136 0.5 mgParticipants will receive a single oral dose of SYHA136 0.5 mg or Placebo matching SYHA136 0.5 mg under fasted conditions. |
| Cohort 2:SYHA136 1 mg or Placebo matching SYHA136 1 mg | Experimental | Drug: SYHA136 1 mg, Drug: Placebo matching SYHA136 1 mgParticipants will receive a single oral dose of SYHA136 1 mg or Placebo matching SYHA136 1 mg under fasted conditions. |
| Cohort 3:SYHA136 2.5 mg or Placebo matching SYHA136 2.5 mg | Experimental | Drug: SYHA136 2.5 mg, Drug: Placebo matching SYHA136 2.5 mgParticipants will receive a single oral dose of SYHA136 2.5 mg or Placebo matching SYHA136 2.5 mg under fasted conditions. |
| Cohort 4:SYHA136 5 mg or Placebo matching SYHA136 5 mg | Experimental | Drug: SYHA136 5 mg, Drug: Placebo matching SYHA136 5 mgParticipants will receive a single oral dose of SYHA136 5 mg or Placebo matching SYHA136 5 mg under fasted conditions. |
| Cohort 5:SYHA136 10 mg or Placebo matching SYHA136 10 mg | Experimental | Drug: SYHA136 10 mg, Drug: Placebo matching SYHA136 10 mgParticipants will receive a single oral dose of SYHA136 10 mg or Placebo matching SYHA136 10 mg under fasted conditions. |
| Cohort 6:SYHA136 20 mg or Placebo matching SYHA136 20 mg | Experimental | Drug: SYHA136 20 mg, Drug: Placebo matching SYHA136 20 mgParticipants will receive a single oral dose of SYHA136 20 mg or Placebo matching SYHA136 20 mg under fasted conditions. |
| Cohort 7:SYHA136 35 mg or Placebo matching SYHA136 35 mg | Experimental | Drug: SYHA136 35 mg, Drug: Placebo matching SYHA136 35 mgParticipants will receive a single oral dose of SYHA136 35 mg or Placebo matching SYHA136 35 mg under fasted conditions. |
| Cohort 1:SYHA136 50 mg or Placebo matching SYHA136 50 mg | Experimental | Drug: SYHA136 50 mg, Drug: Placebo matching SYHA136 50 mgParticipants will receive a single oral dose of SYHA136 50 mg or Placebo matching SYHA136 50 mg under fasted conditions. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- When subject signs the informed contest, 18≤ age ≤ 40, Male or female;
- Body weight: male ≥50 kg, female ≥45 kg. Body mass index (BMI) of 19.0 to 26.0 kg/m², inclusive;
- Subject's with normal or or abnormity without clinical significance judged by the investigator by physical examination, vital signs, electrocardiogram, blood routine, blood biochemistry, coagulation tests, fecal occult blood, urine routine, serological tests and other important indicators;
- All subjects who adopt effective non-hormonal contraceptive measures (such as condoms, intrauterine devices without drugs, etc.) from the signing of informed consent to three months after the end of the study;
- Subjects who voluntarily signed the informed consent and are able to cooperate to complete the test according to the protocal.
Key exclusion criteria (19 listed)
- Allergic history to more than one drug or other serious allergic rhistory;
- Serious diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders or other diseases (such as history of psychosis, malignant tumors, etc.)In the past or now, which were not suitable for clinical trials.
- History of abnormal bleeding or coagulation disorders (e.g. prone to bruising, gum bleeding, prolonged bleeding after tooth extraction, joint hemorrhage, menorrhagia, postpartum hemorrhage, vitamin K deficiency, haemorrhagic diseases caused by acquired coagulation factor antibodies, trauma, wound or post-operative bleeding, etc.);
- History of severe head trauma in 2 years;
- Severe gastrointestinal diseases occurred within three months before signing informed consent, which affected drug absorption;
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 |
|---|---|---|
| SYHA136 0.5 mgoral tablet | Drug | Cohort 1:SYHA136 0.5 mg or Placebo matching SYHA136 0.5 mg |
| SYHA136 1 mgoral tablet | Drug | Cohort 2:SYHA136 1 mg or Placebo matching SYHA136 1 mg |
| SYHA136 2.5 mgoral tablet | Drug | Cohort 3:SYHA136 2.5 mg or Placebo matching SYHA136 2.5 mg |
| SYHA136 5 mgoral tablet | Drug | Cohort 4:SYHA136 5 mg or Placebo matching SYHA136 5 mg |
| SYHA136 10 mgoral tablet | Drug | Cohort 5:SYHA136 10 mg or Placebo matching SYHA136 10 mg |
| SYHA136 20 mgoral tablet | Drug | Cohort 6:SYHA136 20 mg or Placebo matching SYHA136 20 mg |
| SYHA136 35 mgoral tablet | Drug | Cohort 7:SYHA136 35 mg or Placebo matching SYHA136 35 mg |
| SYHA136 50 mgoral tablet | Drug | Cohort 1:SYHA136 50 mg or Placebo matching SYHA136 50 mg |
| Placebo matching SYHA136 0.5 mgoral tablet | Drug | Cohort 1:SYHA136 0.5 mg or Placebo matching SYHA136 0.5 mg |
| Placebo matching SYHA136 1 mgoral tablet | Drug | Cohort 2:SYHA136 1 mg or Placebo matching SYHA136 1 mg |
| Placebo matching SYHA136 2.5 mgoral tablet | Drug | Cohort 3:SYHA136 2.5 mg or Placebo matching SYHA136 2.5 mg |
| Placebo matching SYHA136 5 mgoral tablet | Drug | Cohort 4:SYHA136 5 mg or Placebo matching SYHA136 5 mg |
| Placebo matching SYHA136 10 mgoral tablet | Drug | Cohort 5:SYHA136 10 mg or Placebo matching SYHA136 10 mg |
| Placebo matching SYHA136 20 mgoral tablet | Drug | Cohort 6:SYHA136 20 mg or Placebo matching SYHA136 20 mg |
| Placebo matching SYHA136 35 mgoral tablet | Drug | Cohort 7:SYHA136 35 mg or Placebo matching SYHA136 35 mg |
| Placebo matching SYHA136 50 mgoral tablet | Drug | Cohort 1:SYHA136 50 mg or Placebo matching SYHA136 50 mg |
Primary outcome
Adverse Events (AEs)
Time frame: From Screening period to 12 Days Post dose
Number of participants that experience Adverse Events (AEs)
Serious Adverse Events (SAEs)
Time frame: From Screening period to 12 Days Post dose
Number of participants that experience Serious Adverse Events (SAEs)
clinically significant laboratory assessment abnormalities
Time frame: Up to 72 hours Post dose
Number of participants with clinically significant laboratory assessment abnormalities
clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Time frame: Up to 72 hours Post dose
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
clinically significant physical examination abnormalities
Time frame: Up to 72 hours Post dose
Number of participants with clinically significant physical examination abnormalities
14 secondary outcomes
Area Under the concentration-time curve from time zero to time of the Last Measurable Concentration (AUC0-tlast)
Time frame: Up to 72 hours Post dose
Area under the concentration-time curve from time 0 to infinity (AUCinf)
Time frame: Up to 72 hours Post dose
Maximum observed concentration (Cmax)
Time frame: Up to 72 hours Post dose
Time to reach maximum observed concentration (Tmax)
Time frame: Up to 72 hours Post dose
Terminal elimination half-life (t1/2)
Time frame: Up to 72 hours Post dose
Apparent total body clearance (CL/F)
Time frame: Up to 72 hours Post dose
Apparent volume of distribution (Vz/F)
Time frame: Up to 72 hours Post dose
Amount of SYHA136 excreted in urine (Aeu)
Time frame: Up to 72 hours Post dose
Renal clearance (CLr)
Time frame: Up to 72 hours Post dose
Activated Partial Thromboplastin Time(aPTT)
Time frame: Up to 48 hours Post dose
Fibrinogen(Fbg)
Time frame: Up to 48 hours Post dose
Thrombin Time(TT)
Time frame: Up to 48 hours Post dose
International Normalized Ratio(INR)
Time frame: Up to 48 hours Post dose
Anti-coagulation Factor Xa assays(AXA)
Time frame: Up to 48 hours Post dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SYHA136 0.5 mg, SYHA136 1 mg and SYHA136 2.5 mg in people with Venous Thrombosis, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
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: status not confirmed, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Adverse Events (AEs) (time frame: From Screening period to 12 Days Post dose). 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 30 Jul 2019.