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
Overview
- Phase
- Phase 1
- Intervention
- SYHX 1901 tablets
- Conditions
- Healthy Subjects
- Sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Safety and tolerability of SYHX1901 tablets
- Last Updated
- 4 years ago
Overview
Brief 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
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 n
- •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.
Exclusion Criteria
- •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;
- •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;
Arms & Interventions
SYHX 1901 tablets for SAD
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.
Intervention: SYHX 1901 tablets
Placebo for SAD
2 out of 10 healthy subjects will be randomized to receive a single dose of placebo in fasted state
Intervention: Placebo
SYHX 1901 tablets for MAD
8 out of 10 healthy subjects will be randomized to receive multiple doses of SYHX 1901 tablets in fasted state
Intervention: SYHX 1901 tablets
Placebo for MAD
2 out of 10 healthy subjects will be randomized to receive multiple doses of placebo in fasted state
Intervention: Placebo
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Fecal PK parameters(Pre-dose and multiple timepoints up to 144 hours after the dose（180 mg）)
- Identification of Metabolites of SYHX1901(Pre-dose and multiple timepoints up to 144 hours after the dose（180 mg）)
- PD indexes: the level of PSTATs in blood cells(Pre-dose and multiple timepoints up to 144 hours after the last dose)
- The PK of SYHX1901 following single-dose and multiple doses(Pre-dose and multiple timepoints up to 144 hours after the last dose)
- Urine PK parameters(Pre-dose and multiple timepoints up to 144 hours after the dose（180 mg）)
- PD indexes: the inhibition rate of PSTATs in blood cells(Pre-dose and multiple timepoints up to 144 hours after the last dose)