NCT04161547

Completed

Phase 1

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

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 site in 1 country40 target enrollmentDecember 12, 2019

InterventionsCSPCHA115 100 mg; Matching placebo 100 mg CSPCHA115 200 mg; Matching placebo 200 mg CSPCHA115 400 mg; Matching placebo 400 mg CSPCHA115 600 mg; Matching placebo 600 mg

DrugsCSPCHA115 100 mg; Matching placebo 100 mg CSPCHA115 200 mg; Matching placebo 200 mg CSPCHA115 400 mg; Matching placebo 400 mg CSPCHA115 600 mg; Matching placebo 600 mg

Overview

Phase: Phase 1
Intervention: CSPCHA115 100 mg; Matching placebo 100 mg
Conditions: Asthma; Allergic Rhinitis
Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Enrollment: 40
Locations: 1
Primary Endpoint: Number of subjects with clinically significant electrocardiograms (ECGs) abnormalities
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 12, 2019

End Date

June 1, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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;

Arms & Interventions

Cohort A1: CSPCHA115 100 mg

CSPCHA115 100 mg or placebo administered orally in the fasted state for 7 days. * Eight subjects will receive CSPCHA115 * Two subjects will receive matching placebo

Intervention: CSPCHA115 100 mg; Matching placebo 100 mg

Cohort A2: CSPCHA115 200 mg

CSPCHA115 200 mg or placebo administered orally in the fasted state for 7 days. * Eight subjects will receive CSPCHA115 * Two subjects will receive matching placebo

Intervention: CSPCHA115 200 mg; Matching placebo 200 mg

Cohort A3: CSPCHA115 400 mg

CSPCHA115 400 mg or placebo administered orally in the fasted state for 7 days. * Eight subjects will receive CSPCHA115 * Two subjects will receive matching placebo

Intervention: CSPCHA115 400 mg; Matching placebo 400 mg

Cohort A4: CSPCHA115 600 mg

CSPCHA115 600 mg or placebo administered orally in the fasted state for 7 days. * Eight subjects will receive CSPCHA115 * Two subjects will receive matching placebo

Intervention: CSPCHA115 600 mg; Matching placebo 600 mg

Outcomes

Primary Outcomes

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

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

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

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

Cmin at steady state (Css min)

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

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

Time to reach maximum observed concentration (Tmax)

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

Maximum observed concentration (Cmax)

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

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

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

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

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

Cmax at steady state (Css max)

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

Apparent volume of distribution (Vz/F)

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

Average concentration at steady state (Css av)

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

Fluctuation coefficient (DF)

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

Accumulation ratio (Rac)

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

AUC at steady state (AUCss)

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

Elimination half-life (t1/2)

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

Apparent clearance at steady state (CLss/F)

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

Study Sites (1)

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