The Safety, Tolerability, and Pharmacokinetics of SYHX1901 Tablets in Chinese Healthy Subjects

NCT04880512 | Unknown Phase 1

• 1 other identifier: SYHX1902-CSP-001
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

• The PK of SYHX1901 following single-dose and multiple doses

  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

• The PK of SYHX1901 following single-dose and multiple doses

  Pre-dose and multiple timepoints up to 144 hours after the last dose

Study Arms (4)

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.

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

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

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

Drug: Placebo

Interventions

SYHX 1901 tablets DRUG

SYHX 1901, oral tablets, in fasted state

SYHX 1901 tablets for MAD; SYHX 1901 tablets for SAD

Placebo DRUG

Matching placebo, oral tablets, in fasted state

Placebo for MAD; Placebo for SAD

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• CSPC Ouyi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Huashan Hospital of Fudan University

Shanghai, China

RECRUITING

Study Officials

• jing zhang, Medical PhD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ying hu, master

CONTACT

15021575058; hyy1102030@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 10, 2021
• Study Start: May 31, 2021
• Primary Completion: August 20, 2022
• Study Completion: December 20, 2022
• Last Updated: September 30, 2021

Record last verified: 2021-09

Locations

CN (1)