Asthma; Allergic RhinitisPhase 1NCT04161547
Tolerability and Pharmacokinetics of CSPCHA115 Capsules in Chinese Healthy Volunteers
A Phase 1 study of Asthma; Allergic Rhinitis, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma; Allergic Rhinitis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2019to 1 Jun 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000
About this study
Official title: A Phase I, Ascending Multiple-dose Clinical Trial of CSPCHA115 Capsules to Evaluate the Tolerability and Pharmacokinetics 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.
- Conditions
- Asthma; Allergic Rhinitis
- Being tested
- CSPCHA115 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
- Keywords
- CSPCHA115, Asthma, CRTH2
- Medical subject headings
- Asthma, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSPCHA115 100 mg; Matching placebo 100 mgDrug
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 mgDrug
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 mgDrug
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 mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A1: CSPCHA115 100 mg | Experimental | 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 Receives: Drug: CSPCHA115 100 mg; Matching placebo 100 mg |
| Cohort A2: CSPCHA115 200 mg | Experimental | 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 Receives: Drug: CSPCHA115 200 mg; Matching placebo 200 mg |
| Cohort A3: CSPCHA115 400 mg | Experimental | 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 Receives: Drug: CSPCHA115 400 mg; Matching placebo 400 mg |
| Cohort A4: CSPCHA115 600 mg | Experimental | 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 Receives: Drug: CSPCHA115 600 mg; Matching placebo 600 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and incidence of subjects with Adverse Events (AEs)
To evaluate the safety and tolerability after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg
Measured: 12 days after drug administration
Number of subjects with clinically significant symptoms abnormalities
To evaluate the safety and tolerability after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg
Measured: 10 days after drug administration
Number of subjects with clinically significant vital sign abnormalities
To evaluate the safety and tolerability after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg
Measured: 10 days after drug administration
Number of subjects with clinically significant physical examination abnormalities
To evaluate the safety and tolerability after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg
Measured: 10 days after drug administration
Number of subjects with clinically significant laboratory abnormalities
To evaluate the safety and tolerability after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg
Measured: 10 days after drug administration
Number of subjects with clinically significant electrocardiograms (ECGs) abnormalities
To evaluate the safety and tolerability after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg
Measured: 10 days after drug administration
Time to reach maximum observed concentration (Tmax)
To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg
Measured: 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
Maximum observed concentration (Cmax)
To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg
Measured: 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
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
Measured: 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
Tmax at steady state (Tss max)
To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg
Measured: 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
Cmax at steady state (Css max)
To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg
Measured: 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
Cmin at steady state (Css min)
To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg
Measured: 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
Average concentration at steady state (Css av)
To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg
Measured: 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
AUC at steady state (AUCss)
To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg
Measured: 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
Elimination half-life (t1/2)
To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg
Measured: 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
Apparent clearance at steady state (CLss/F)
To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg
Measured: 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
Apparent volume of distribution (Vz/F)
To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg
Measured: 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
Fluctuation coefficient (DF)
To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg
Measured: 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
Accumulation ratio (Rac)
To evaluate the pharmacokinetics after repeated administrations of CSPCHA115 capsules 100, 200, 400 and 600 mg
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start12 Dec 2019
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma; Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xuefang Xia, Study director, Department of Medicine, CSPC Clinical Development Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161547
- Sponsor's protocol ID
- HA116201903/PRO I-MAD
- Status last verified
- Apr 2021
- First submitted
- 29 Oct 2019
- Last updated
- 28 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Ascending Multiple-dose Clinical Trial of CSPCHA115 Capsules to Evaluate the Tolerability and Pharmacokinetics in Chinese Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04161547
- Acronym / sponsor ID
- HA116201903/PRO I-MAD
- Conditions
- Asthma; Allergic Rhinitis
- Keywords
- CSPCHA115, Asthma, CRTH2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 13 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A1: CSPCHA115 100 mg | Experimental | Drug: CSPCHA115 100 mg; Matching placebo 100 mgCSPCHA115 100 mg or placebo administered orally in the fasted state for 7 days. * Eight subjects will receive CSPCHA115 * Two subjects will receive matching placebo |
| Cohort A2: CSPCHA115 200 mg | Experimental | Drug: CSPCHA115 200 mg; Matching placebo 200 mgCSPCHA115 200 mg or placebo administered orally in the fasted state for 7 days. * Eight subjects will receive CSPCHA115 * Two subjects will receive matching placebo |
| Cohort A3: CSPCHA115 400 mg | Experimental | Drug: CSPCHA115 400 mg; Matching placebo 400 mgCSPCHA115 400 mg or placebo administered orally in the fasted state for 7 days. * Eight subjects will receive CSPCHA115 * Two subjects will receive matching placebo |
| Cohort A4: CSPCHA115 600 mg | Experimental | Drug: CSPCHA115 600 mg; Matching placebo 600 mgCSPCHA115 600 mg or placebo administered orally in the fasted state for 7 days. * Eight subjects will receive CSPCHA115 * Two subjects will receive matching placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSPCHA115 100 mg; Matching placebo 100 mgCSPCHA115 100 mg once daily in the fasted state for 7 days; Matching placebo 100 mg once daily in the fasted state for 7 days. | Drug | Cohort A1: CSPCHA115 100 mg |
| CSPCHA115 200 mg; Matching placebo 200 mgCSPCHA115 200 mg once daily in the fasted state for 7 days; Matching placebo 200 mg once daily in the fasted state for 7 days. | Drug | Cohort A2: CSPCHA115 200 mg |
| CSPCHA115 400 mg; Matching placebo 400 mgCSPCHA115 400 mg once daily in the fasted state for 7 days; Matching placebo 400 mg once daily in the fasted state for 7 days. | Drug | Cohort A3: CSPCHA115 400 mg |
| CSPCHA115 600 mg; Matching placebo 600 mgCSPCHA115 600 mg once daily in the fasted state for 7 days; Matching placebo 600 mg once daily in the fasted state for 7 days. | Drug | Cohort A4: CSPCHA115 600 mg |
Primary outcome
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 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 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
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RecruitingObservational study
A Biorepository of Multiple Allergic Diseases (MADREP) With Longitudinal Follow-Up
Allergy, Sinus Disorders, Atopic Diseases, Asthma, Allergic Rhinitis, Atopic Dermatitis, EoE, Drug a
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xuefang Xia study director
Department of Medicine, CSPC Clinical Development Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Asthma; Allergic Rhinitis, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and incidence of subjects with Adverse Events (AEs) (time frame: 12 days after drug administration). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.