- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03619616
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose of ZSP1603 in Healthy Adults
A Phase 1 Randomized,Double-Blind,Parallel-Group, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ZSP1603 in Chinese Healthy Subjects
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Hunan
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Changsha, Hunan, China, 410013
- The Third Xiangya Hospital of Central South University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Subjects are required to meet the following criteria in order to be included in the trial:
- Males and female subjects between 18-50 years (Both inclusive).
- Body weight is no less than 50 kg in males and no less than 45 kg in females. Body mass index (BMI) 19.0 ≤ BMI ≤ 26.0 kg/m2; BMI is determined by the following equation: BMI = weight/height2 (kg/m2).
- Males or females are without gestation plans or infertility, or females who are menopausal, otherwise must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.
- Signature of a dated Informed Consent Form (ICF) indicating that the subject has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment.
- Subjects must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study.
Exclusion Criteria:
Eligible subjects must not meet any of the following exclusion criteria:
- History or presence of any clinical severe diseases (such as circulatory system, endocrine , neurologic, gastrointestinal, respiratory system, urogenital system, hematic, immune, psychiatric and metabolic abnormalities), or any other diseases that,in the Investigator's opinion,might interfere with the assessment or follow-up;
- Known hypersensitivity and/or allergy to some drugs and food,especially for the composition that is similar to the investigative product;
- Subjects who have received a surgery within 4 weeks prior to the test or who plan to perform a surgery during the study;
- Use of any drugs or health care products (including herbs) within 14 days prior to screening.
- Any drugs with known hepatic enzyme-inducing or inhibiting agents that may change the activity of CYP3A4 within 30 days prior to dosing (such as inducer - Barbituric , Carmazepin , Phenyltoin , Glucocorticoids , and Omeprazole ; Inhibitors - SSRI antidepressants , Cimitedin , Diltiazem , Macrolides , Nitroimidazoles , Sedative hypnotic , Verapamil , Fluoroquinolone , Anti - histamine ).
- Participated in another clinical research study and received any other investigational products within 3 months prior to dosing.
- Subjects who donated blood or bleeding profusely(≥ 200 mL), received blood transfusion or use of blood products in the 3 months preceding study screening.
- Pregnancy or breastfeeding at screening and during the study. All female subjects of childbearing potential and their partners cannot use at least one reliable method of non-drug contraception during the study and until 6 months following the last dose of investigational product.
- Subjects who have special dietary habit and inability to consume the food provided in the study;
- Subjects who could not tolerate venipuncture;
- Dysphagia of capsule;
- Frequently drinks tea, coffee and/or caffeinated beverages(more than 8 cups, 1 cup =250 mL) per day ;
- Daily consuming more than 5 cigarettes within 3 months prior to screening or cannot stop using any tobacco products during the trial.
- Smoke or have grapefruit juice,any food or beverage that contains alcohol or xanthin (including chocolate, tea, coffee, cola, etc.) from 48 hours pre-dose to the last blood collection ;
- Known history of alcohol abuse (defined as consumption of more than 14 units of alcohol per week: 1 unit=360 ml of beer,or the equivalent of 45 mL liquor with 40% alcohol content, or 150 ml of wine;)or take any product contains alcohol during the study.
- Known history of drug abuse or subjects who have used soft drugs (e.g., marijuana) within 3 months prior to screening, or have taken hard drugs (such as cocaine, phencyclidine, etc.) within one year before screening.
- Presence clinically significant abnormalities (based on the judgment of clinical research doctors) of vital signs (systolic pressure <90 mmHg or >140 mmHg; diastolic pressure <60 mmHg or >90 mmHg;HR <50 bpm or>100 bpm) or ECG (QTcB>450ms in males, or QTcB>480ms in females) or physical examination, clinical laboratory tests and imaging examination.
- Subjects who may not complete the study for other reasons or should not be included in the study in the opinion of the Investigator.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: ZSP1603 (single dose)-7.5 mg (Cohort 1)
Subject adminsitered at a dose of ZSP1603 7.5 mg on day 1 under fasted condition.
|
ZSP1603 capsule administered orally once daily under fasted condition.
|
EXPERIMENTAL: ZSP1603 (single dose)-12.5mg (Cohort 2)
Subject adminsitered at a dose of ZSP1603 12.5 mg or placebo on day 1 under fasted condition. Enrollment into Cohort 2 will begin upon assurance of safety for Cohort 1. |
ZSP1603 capsule administered orally once daily in the fasting state.
Participants will receive placebo matching to ZSP1603 orally once daily under fasted condition.
|
EXPERIMENTAL: ZSP1603 (single dose)-25 mg (Cohort 3)
Subject adminsitered at a dose of ZSP1603 25 mg or placebo on day 1 under fasted condition. Enrollment into Cohort 3 will begin upon assurance of safety for Cohort 2. |
ZSP1603 capsule administered orally once daily under fasted condition.
Participants will receive placebo matching to ZSP1603 orally once daily in the fasting state.
|
EXPERIMENTAL: ZSP1603 (single dose)-50 mg (Cohort 4)
Subject adminsitered at a dose of ZSP1603 50 mg or placebo on day 1 under fasted condition. Enrollment into Cohort 4 will begin upon assurance of safety for Cohort 3. |
ZSP1603 capsule administered orally once daily under fasted state.
Participants will receive placebo matching to ZSP1603 orally once daily in the fasting state.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with treatment-emergent adverse events (TEAEs) following oral doses of ZSP1603 and placebo,separately.
Time Frame: At Day 6 post-dose.
|
Number of participants with TEAEs as assessed by CTCAE v5.0.
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At Day 6 post-dose.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUClast(AUC0-t)of ZSP1603
Time Frame: Up to 6 days post-dose
|
AUClast is defined as the concentration of drug from time zero to the last quantifiable concentration.
|
Up to 6 days post-dose
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AUC0-24 of ZSP1603
Time Frame: Up to 6 days post-dose
|
AUC0-24 is defined as the concentration of drug from zero(0) hrs to 24h (area under the plasma concentration versus time curve from zero(0) hrs to 24h).
|
Up to 6 days post-dose
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Cmax of ZSP1603
Time Frame: Up to 6 days post-dose
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Cmax is defined as the maximum observed concentration of drug in plasma.
|
Up to 6 days post-dose
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Tmax of ZSP1603
Time Frame: Up to 6 days post-dose
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Tmax is defined as the time to maximum concentration.
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Up to 6 days post-dose
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t1/2 of ZSP1603
Time Frame: Up to 6 days post-dose
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t1/2 is defined as the time to half of the drug concentration in plasma.
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Up to 6 days post-dose
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CL/F of ZSP1603
Time Frame: Up to 6 days post-dose
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CL/F is defined as the ratio of total clearance(CL) to bioavailability(F).
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Up to 6 days post-dose
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λz of ZSP1603
Time Frame: Up to 6 days post-dose
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λz is defined as the ratio between the elimination of compound per unit time and the total amount of compound.
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Up to 6 days post-dose
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VD/F of ZSP1603
Time Frame: Up to 6 days post-dose
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VD/F is defined as apparent volume of distribution
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Up to 6 days post-dose
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MRT of ZSP1603
Time Frame: Up to 6 days post-dose
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MRT is defined as mean residence time
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Up to 6 days post-dose
|
Collaborators and Investigators
Investigators
- Principal Investigator: Guoping Yang, MD, The Third Xiangya Hospital of Central South University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XY3-PK-ZSP1603
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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