Tolerability and Pharmacokinetics of CSPCHA115 Capsules in Chinese Healthy Volunteers

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

NCT04161547•CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

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;
+5 more criteria

Locations (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Key Dates

Start Date

December 12, 2019

Primary Completion Date

June 1, 2020

Completion Date

June 1, 2020

Last Updated

April 28, 2021

Enrollment

ACTUAL participants

Conditions

Asthma; Allergic Rhinitis

Interventions

CSPCHA115 100 mg; Matching placebo 100 mg

DRUG

CSPCHA115 200 mg; Matching placebo 200 mg

DRUG

CSPCHA115 400 mg; Matching placebo 400 mg

DRUG

CSPCHA115 600 mg; Matching placebo 600 mg

DRUG