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NCT Number: NCT04161547

Tolerability and Pharmacokinetics of CSPCHA115 Capsules in Chinese Healthy Volunteers

A randomized, single-center, double-blind, ascending multiple-dose, placebo-controlled study to evaluate the tolerability and pharmacokinetics of CSPCHA115 capsules in Chinese healthy volunteers.

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Key information

Conditions

Asthma; Allergic Rhinitis Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 ≤ age ≤ 45 years old, male or female;
  • Bodyweight≥45.0 kg (female) or 50.0 kg (male), 19 kg/m^2 ≤ Body Mass Index（BMI ）≤ 26 kg/m^2;
  • The female subjects are not during pregnancy or lactation; the male subjects have no sperm donation plan from the signing of the informed consent form to 1 month after the completion of the study. The subjects and their partners agree to use effective non-hormonal contraceptives (such as condoms, drug-free IUDs, etc.) from the day signing the informed consent form to 1 month after the completion of the study, or had taken permanent contraceptives (such as bilateral tubal ligation, vasectomy, etc.);
  • Subjects voluntarily sign the informed consent form, and are able to complete the trial according to the protocol;

Exclusion criteria

Those who conform to one of the following provisions shall not be included in the group;

  • A clear history of neurological or mental disorders (including seizures, dementia, depression or biphasic affective disorders, etc.); immunodeficient or immunosuppressive diseases, malignant tumor diseases; cardiovascular, liver and kidney, endocrine, respiratory, blood, digestive system and other chronic diseases;
  • Subjects who underwent large surgical operations within 6 months before signing the informed consent (such as coronary artery bypass grafting, hepatorenectomy, nephrectomy, gynecological surgery, etc.), and those with acute neurological, digestive, respiratory, circulation, endocrine, blood and other systemic diseases within 3 months before signing the informed consent form may affect the absorption, distribution, metabolism and excretion of drugs;
  • Subjects with allergic constitutions, or who are allergic to more than 1 drug, or had other known serious allergic reactions;
  • Subjects who did not meet the health criteria during the screening period, including abnormal vital signs; QTc interval ≥ 450 ms (male) or 470ms (female), prolongation of QTc interval, or other abnormal clinical significance of electrocardiogram (ECG); the results of physical examination, laboratory examination and so on are abnormal and have clinical significance.
  • One of hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (Anti-HCV), human immunodeficiency virus antibody (Anti-HIV) and Treponema pallidum antibody (Anti-TP) was positive;
  • Any prescription drugs, non-prescription drugs, biological products, the Chinese patent medicines, herbs, vitamin dietary supplements, and health-care products (other than external use), oral long-acting contraceptives or embedded long-acting contraceptives were used regularly within 2 weeks before the signing of the informed consent form;
  • A history of alcoholism, or alcohol test positive at screening;
  • The average daily smoking volume was more than 5 within 6 months before signing the informed consent form;
  • Drug abuse within 1 year before signing the informed consent form, or urine test positive for drugs at screening;
  • Subjects who were accustomed to excessive caffeine drinks or foods that may affect drug metabolism within 4 weeks prior to the signing of the informed consent form;
  • Subjects who lost blood or donated more than 200 ml within 8 weeks before signing the informed consent form, or who planned to donate blood within 1 month after the completion of the study;
  • Subjects who plan to undergo surgery during the trial period, or those who plan to take part in strenuous exercise during the trial period;
  • Subjects who are participating in other clinical trials, or who have participated in clinical trial about any other drugs or devices within 3 months before signing the informed consent form;
  • Not suitable for this clinical trial judged by the investigators.

Treatment and study plan

CSPCHA115 100 mg; Matching placebo 100 mg

Drug

CSPCHA115 100 mg once daily in the fasted state for 7 days; Matching placebo 100 mg once daily in the fasted state for 7 days.

CSPCHA115 200 mg; Matching placebo 200 mg

Drug

CSPCHA115 200 mg once daily in the fasted state for 7 days; Matching placebo 200 mg once daily in the fasted state for 7 days.

CSPCHA115 400 mg; Matching placebo 400 mg

Drug

CSPCHA115 400 mg once daily in the fasted state for 7 days; Matching placebo 400 mg once daily in the fasted state for 7 days.

CSPCHA115 600 mg; Matching placebo 600 mg

Drug

CSPCHA115 600 mg once daily in the fasted state for 7 days; Matching placebo 600 mg once daily in the fasted state for 7 days.

Primary outcomes

  1. Number and incidence of subjects with Adverse Events (AEs)

    Time frame: 12 days after drug administration

    To evaluate the safety and tolerability after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

  2. Number of subjects with clinically significant symptoms abnormalities

    Time frame: 10 days after drug administration

    To evaluate the safety and tolerability after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

  3. Number of subjects with clinically significant vital sign abnormalities

    Time frame: 10 days after drug administration

    To evaluate the safety and tolerability after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

  4. Number of subjects with clinically significant physical examination abnormalities

    Time frame: 10 days after drug administration

    To evaluate the safety and tolerability after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

  5. Number of subjects with clinically significant laboratory abnormalities

    Time frame: 10 days after drug administration

    To evaluate the safety and tolerability after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

  6. Number of subjects with clinically significant electrocardiograms (ECGs) abnormalities

    Time frame: 10 days after drug administration

    To evaluate the safety and tolerability after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

  7. Time to reach maximum observed concentration (Tmax)

    Time frame: Day 1(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours); Day 5(Pre-dose); Day 6(Pre-dose); Day 7(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours) after drug administration

    To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

  8. Maximum observed concentration (Cmax)

    Time frame: Day 1(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours); Day 5(Pre-dose); Day 6(Pre-dose); Day 7(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours) after drug administration

    To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

  9. Area under the concentration-time curve from time 0 to 24h (AUC0-24h)

    Time frame: Day 1(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours); Day 5(Pre-dose); Day 6(Pre-dose); Day 7(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours) after drug administration

    To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

  10. Tmax at steady state (Tss max)

    Time frame: Day 1(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours); Day 5(Pre-dose); Day 6(Pre-dose); Day 7(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours) after drug administration

    To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

  11. Cmax at steady state (Css max)

    Time frame: Day 1(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours); Day 5(Pre-dose); Day 6(Pre-dose); Day 7(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours) after drug administration

    To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

  12. Cmin at steady state (Css min)

    Time frame: Day 1(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours); Day 5(Pre-dose); Day 6(Pre-dose); Day 7(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours) after drug administration

    To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

  13. Average concentration at steady state (Css av)

    Time frame: Day 1(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours); Day 5(Pre-dose); Day 6(Pre-dose); Day 7(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours) after drug administration

    To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

  14. AUC at steady state (AUCss)

    Time frame: Day 1(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours); Day 5(Pre-dose); Day 6(Pre-dose); Day 7(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours) after drug administration

    To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

  15. Elimination half-life (t1/2)

    Time frame: Day 1(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours); Day 5(Pre-dose); Day 6(Pre-dose); Day 7(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours) after drug administration

    To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

  16. Apparent clearance at steady state (CLss/F)

    Time frame: Day 1(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours); Day 5(Pre-dose); Day 6(Pre-dose); Day 7(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours) after drug administration

    To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

  17. Apparent volume of distribution (Vz/F)

    Time frame: Day 1(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours); Day 5(Pre-dose); Day 6(Pre-dose); Day 7(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours) after drug administration

    To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

  18. Fluctuation coefficient (DF)

    Time frame: Day 1(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours); Day 5(Pre-dose); Day 6(Pre-dose); Day 7(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours) after drug administration

    To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

  19. Accumulation ratio (Rac)

    Time frame: Day 1(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours); Day 5(Pre-dose); Day 6(Pre-dose); Day 7(Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours) after drug administration

    To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg

Sponsors and collaborators

Lead sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Industry

Registry information

Official study title

A Phase I, Ascending Multiple-dose Clinical Trial of CSPCHA115 Capsules to Evaluate the Tolerability and Pharmacokinetics in Chinese Healthy Volunteers

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 13, 2019
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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