Healthy SubjectsPhase 1NCT04880512
The Safety, Tolerability, and Pharmacokinetics of SYHX1901 Tablets in Chinese Healthy Subjects
A Phase 1 study testing SYHX 1901 tablets in people with Healthy Subjects, run by CSPC Ouyi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a phase I clinical trial to evaluate the safety, tolerability and pharmacokinetic characteristics of single ascending doses and multiple ascending doses of SYHX1901 tablets in Chinese healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- SYHX 1901 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2021to 20 Dec 2022
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects aged 18 to 45 years (inclusive)；
- Have a body mass index (BMI) between 18.0 and 26.0 kg/m2 (inclusive) and weigh at least 45.0 kg (female) or 50.0 kg (male) at screening；
- Satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by medical history, vital signs, physical examination, and clinical laboratory tests (hematology, urinalysis, and coagulation)；
- Subjects and their partners agree to use effective n4. Subjects and their partners agree to use effective non-hormonal contraceptive measures (e.g., condoms, inert intrauterine devices, female barriers (cervix cap or diaphragm with spermicide), vaginal contraceptive ring, etc.) from signing the informed consent form to 6 months after the end of the study, or have taken permanent contraceptive measures (e.g., bilateral fallopian tube ligation, vasectomy, etc.); male subjects have no sperm donation plan from signing the informed consent to 6 months after the end of the study, female subjects have no egg donation plan from signing the informed consent form to 6 months after the end of the study；
- Subjects who fully understand the study, voluntarily participate in the trial and sign the informed consent form.
Who cannot join
- Prior neurological/ psychiatric, respiratory system, endocrine system, blood system, skeletal-muscular system diseases or liver and kidney dysfunction or other diseases that may affect the results of the study;
- History of severe allergies, herpes zoster infection, or tuberculosis;
- Those who have taken any prescription drugs, over-the-counter drugs, proprietary Chinese medicines, herbal medicines, vitamin dietary supplements and health products within 4 weeks before signing the informed consent, and those who use oral long-acting contraceptives or use embedded long-acting contraceptives；
- Subjects with diseases affecting drug absorption, distribution, metabolism and excretion as judged by investigator (e.g., acute and chronic diarrhea, acute and chronic gastritis, etc.);
- Surgery history within 6 months prior to signing the informed consent;
- Subjects with surgery plan (including cosmetic surgery, dental surgery and oral surgery), or strenuous exercise plan (including physical contact sports or collision sports) during the trial period;
Show all 21Show fewer
- Subjects with any clinically significant abnormalities in ECG, QTcF interval greater than 450 ms (male) or 470 ms (female), or with a history of prolonged QTcF interval;
- Subjects with one or more abnormalities in the vital signs at screening: ear temperature >37.5ºC, pulse rate >100 beats/min, systolic blood pressure ≥140 mmHg or <90 mmHg, diastolic blood pressure >90 mmHg or <50 mmHg；
- The white blood cell count, the absolute value of neutrophils and the absolute value of lymphocytes are below the lower limit or higher than the upper limit of the reference value, and the percentage of reticulocyte (RET) is below the lower limit of the reference value in routine blood tests at screening;
- History of acute respiratory or systemic infections within 2 weeks before signing the informed consent;
- Blood lost or donation more than 400 mL within 3 months before signing the informed consent;
- Alcohol abuse: consumption of more than 14 units of alcohol per week within 4 weeks prior to signing the informed consent or positive test for Alcohol at screening；
- Smoker: more than 5 cigarettes per day within 6 months prior to signing informed consent；
- Habitual intake of excessive xanthine- or caffeine-containing food, beverages, or other factors, which may interfere the absorption, distribution, metabolism, or excretion of drugs, within 4 weeks prior to screening；
- Subjects have participated in clinical trials of any drug or medical device within 3 months before signing the informed consent;
- History of substance abuse within the 1 years prior to signing the informed consent, or positive test for drug abuse at screening；
- Female subjects who are pregnant or lactating;
- Anti-Mullerian hormone (female only) test results not within the reference range at screening;
- Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (anti-HCV), Human immunodeficiency virus antibody (anti-HIV) or Treponema Pallidum antibody (Anti-TP) at screening；
- Suspected or known allergy to the test drug or any ingredient in the test drug, or subjects with allergic constitution;
- Not suitable for this trial as determined by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital of Fudan University
Shanghai
ying hu, master, 15021575058, hyy1102030@163.com
About this study
Official title: A Double-blinded, Randomized, Placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SYHX1901 Tablets in Chinese Healthy Subjects
This is a phase I clinical trial to evaluate the safety, tolerability and pharmacokinetic characteristics of single ascending doses and multiple ascending doses of SYHX1901 tablets in Chinese healthy subjects
Read the detailed description
This study is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetic characteristics of single ascending doses (part 1) and multiple ascending doses (part 2) of SYHX1901 tablets in Chinese healthy subjects.
- Conditions
- Healthy Subjects
- Being tested
- SYHX 1901 tablets, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYHX 1901 tabletsDrug
SYHX 1901, oral tablets, in fasted state
PlaceboDrug
Matching placebo, oral tablets, in fasted state
| Study group | Role | What they receive |
|---|---|---|
| SYHX 1901 tablets for SAD | Experimental | Two subjects will be enrolled in a single dose group which is recommended as the initial dose. 8 out of 10 healthy subjects will be randomized to receive a single dose of SYHX 1901 tablets in fasted state. Receives: Drug: SYHX 1901 tablets |
| Placebo for SAD | Placebo comparator | 2 out of 10 healthy subjects will be randomized to receive a single dose of placebo in fasted state Receives: Drug: Placebo |
| SYHX 1901 tablets for MAD | Experimental | 8 out of 10 healthy subjects will be randomized to receive multiple doses of SYHX 1901 tablets in fasted state Receives: Drug: SYHX 1901 tablets |
| Placebo for MAD | Placebo comparator | 2 out of 10 healthy subjects will be randomized to receive multiple doses of placebo in fasted state Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of SYHX1901 tablets
The safety and tolerability of single or multiple doses of SYHX1901 tablets administered orally will be assessed by incidence and severity of adverse events (AEs), abnormalities in clinical laboratory assessments, ECGs, vital sign assessments, and physical exams.
Measured: SAD: up to14 days after the dosing, MAD: up to 7 days after the last dosing
Secondary outcomes (11)
The PK of SYHX1901 following single-dose and multiple doses
Peak Plasma Concentration (Cmax) of SYHX1901 following single-dose and multiple doses
Measured: Pre-dose and multiple timepoints up to 144 hours after the last dose
The PK of SYHX1901 following single-dose and multiple doses
Area under the plasma concentration versus time curve (AUC) of SYHX1901 following single-dose and multiple doses
Measured: Pre-dose and multiple timepoints up to 144 hours after the last dose
The PK of SYHX1901 following single-dose and multiple doses
The concentration peak time of SYHX1901 following single-dose and multiple doses
Concentration peak time
The peak time of SYHX1901 concentration following single-dose
Measured: Pre-dose and multiple timepoints up to 144 hours after the last dose
The PK of SYHX1901 following single-dose and multiple doses
The half-time of SYHX1901 following single-dose and multiple doses
The half - time of SYHX1901 following single-dose
Measured: Pre-dose and multiple timepoints up to 144 hours after the last dose
The PK of SYHX1901 following single-dose and multiple doses
The plasma clearance rate （CL）of SYHX1901 following single-dose and multiple doses
Measured: Pre-dose and multiple timepoints up to 144 hours after the last dose
Urine PK parameters
Urine pharmacokinetic parameters: The Urine clearance rate （CLr）of SYHX1901
Measured: Pre-dose and multiple timepoints up to 144 hours after the dose（180 mg）
Urine PK parameters
Urine pharmacokinetic parameters: Cumulative excretion from time t1 to t2(Aet1-t2)
Fecal pharmacokinetic parameters:Cumulative excretion from time t1 to t2
Urine pharmacokinetic parameters:cumulative excretion from time t1 to t2
Measured: Pre-dose and multiple timepoints up to 144 hours after the dose（180 mg）
Fecal PK parameters
Fecal pharmacokinetic parameters: cumulative excretion from time t1 to t2(Aft1-t2)
Measured: Pre-dose and multiple timepoints up to 144 hours after the dose（180 mg）
Identification of Metabolites of SYHX1901
It is a prospective study aiming to characterize metabolites of 1901 in human plasma, urine and feces. The metabolism profiles of 1901 and main metabolites will be build up.
Measured: Pre-dose and multiple timepoints up to 144 hours after the dose（180 mg）
PD indexes: the level of PSTATs in blood cells
Pharmacodynamic indexes: the level of PSTATs in blood cells
Measured: Pre-dose and multiple timepoints up to 144 hours after the last dose
PD indexes: the inhibition rate of PSTATs in blood cells
Pharmacodynamic indexes: the inhibition rate of PSTATs in blood cells
Measured: Pre-dose and multiple timepoints up to 144 hours after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start31 May 2021
- Primary completion20 Aug 2022 (estimated)
- Study completion20 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by CSPC Ouyi Pharmaceutical 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- jing zhang, Medical PhD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880512
- Sponsor's protocol ID
- SYHX1902-CSP-001
- Status last verified
- Sep 2021
- First submitted
- 27 Apr 2021
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded, Randomized, Placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SYHX1901 Tablets in Chinese Healthy Subjects
- ClinicalTrials.gov ID
- NCT04880512
- Acronym / sponsor ID
- SYHX1902-CSP-001
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 May 2021 (actual)
- Primary completion
- 20 Aug 2022 (estimated)
- Study completion
- 20 Dec 2022 (estimated)
- First posted
- 10 May 2021 (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 phase I clinical trial to evaluate the safety, tolerability and pharmacokinetic characteristics of single ascending doses and multiple ascending doses of SYHX1901 tablets in Chinese healthy subjects
Detailed description
This study is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetic characteristics of single ascending doses (part 1) and multiple ascending doses (part 2) of SYHX1901 tablets in Chinese healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SYHX 1901 tablets for SAD | Experimental | Drug: SYHX 1901 tabletsTwo subjects will be enrolled in a single dose group which is recommended as the initial dose. 8 out of 10 healthy subjects will be randomized to receive a single dose of SYHX 1901 tablets in fasted state. |
| Placebo for SAD | Placebo comparator | Drug: Placebo2 out of 10 healthy subjects will be randomized to receive a single dose of placebo in fasted state |
| SYHX 1901 tablets for MAD | Experimental | Drug: SYHX 1901 tablets8 out of 10 healthy subjects will be randomized to receive multiple doses of SYHX 1901 tablets in fasted state |
| Placebo for MAD | Placebo comparator | Drug: Placebo2 out of 10 healthy subjects will be randomized to receive multiple doses of placebo in fasted state |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female subjects aged 18 to 45 years (inclusive)；
- Have a body mass index (BMI) between 18.0 and 26.0 kg/m2 (inclusive) and weigh at least 45.0 kg (female) or 50.0 kg (male) at screening；
- Satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by medical history, vital signs, physical examination, and clinical laboratory tests (hematology, urinalysis, and coagulation)；
- Subjects and their partners agree to use effective n4. Subjects and their partners agree to use effective non-hormonal contraceptive measures (e.g., condoms, inert intrauterine devices, female barriers (cervix cap or diaphragm with spermicide), vaginal contraceptive ring, etc.) from signing the informed consent form to 6 months after the end of the study, or have taken permanent contraceptive measures (e.g., bilateral fallopian tube ligation, vasectomy, etc.); male subjects have no sperm donation plan from signing the informed consent to 6 months after the end of the study, female subjects have no egg donation plan from signing the informed consent form to 6 months after the end of the study；
- Subjects who fully understand the study, voluntarily participate in the trial and sign the informed consent form.
Key exclusion criteria (21 listed)
- Prior neurological/ psychiatric, respiratory system, endocrine system, blood system, skeletal-muscular system diseases or liver and kidney dysfunction or other diseases that may affect the results of the study;
- History of severe allergies, herpes zoster infection, or tuberculosis;
- Those who have taken any prescription drugs, over-the-counter drugs, proprietary Chinese medicines, herbal medicines, vitamin dietary supplements and health products within 4 weeks before signing the informed consent, and those who use oral long-acting contraceptives or use embedded long-acting contraceptives；
- Subjects with diseases affecting drug absorption, distribution, metabolism and excretion as judged by investigator (e.g., acute and chronic diarrhea, acute and chronic gastritis, etc.);
- Surgery history within 6 months prior to signing the informed consent;
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 |
|---|---|---|
| SYHX 1901 tabletsSYHX 1901, oral tablets, in fasted state | Drug | SYHX 1901 tablets for MAD, SYHX 1901 tablets for SAD |
| PlaceboMatching placebo, oral tablets, in fasted state | Drug | Placebo for MAD, Placebo for SAD |
Primary outcome
Safety and tolerability of SYHX1901 tablets
Time frame: SAD: up to14 days after the dosing, MAD: up to 7 days after the last dosing
The safety and tolerability of single or multiple doses of SYHX1901 tablets administered orally will be assessed by incidence and severity of adverse events (AEs), abnormalities in clinical laboratory assessments, ECGs, vital sign assessments, and physical exams.
11 secondary outcomes
The PK of SYHX1901 following single-dose and multiple doses
Time frame: Pre-dose and multiple timepoints up to 144 hours after the last dose
The PK of SYHX1901 following single-dose and multiple doses
Time frame: Pre-dose and multiple timepoints up to 144 hours after the last dose
The PK of SYHX1901 following single-dose and multiple doses
Time frame: Pre-dose and multiple timepoints up to 144 hours after the last dose
The PK of SYHX1901 following single-dose and multiple doses
Time frame: Pre-dose and multiple timepoints up to 144 hours after the last dose
The PK of SYHX1901 following single-dose and multiple doses
Time frame: Pre-dose and multiple timepoints up to 144 hours after the last dose
Urine PK parameters
Time frame: Pre-dose and multiple timepoints up to 144 hours after the dose（180 mg）
Urine PK parameters
Time frame: Pre-dose and multiple timepoints up to 144 hours after the dose（180 mg）
Fecal PK parameters
Time frame: Pre-dose and multiple timepoints up to 144 hours after the dose（180 mg）
Identification of Metabolites of SYHX1901
Time frame: Pre-dose and multiple timepoints up to 144 hours after the dose（180 mg）
PD indexes: the level of PSTATs in blood cells
Time frame: Pre-dose and multiple timepoints up to 144 hours after the last dose
PD indexes: the inhibition rate of PSTATs in blood cells
Time frame: Pre-dose and multiple timepoints up to 144 hours after the last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
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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.
jing zhang, Medical PhD principal investigator
Huashan Hospital
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 SYHX 1901 tablets in people with Healthy Subjects, run by CSPC Ouyi 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 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: status not confirmed, as of the sponsor's last update on 30 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ying hu, master (15021575058, hyy1102030@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of SYHX1901 tablets (time frame: SAD: up to14 days after the dosing, MAD: up to 7 days after the last 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 30 Sep 2021.