Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose of ZSP1603 in Healthy Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03619616
• Date of registration: 23/07/2018
• Prospective Registration: No
• Primary sponsor: Guangdong Zhongsheng Pharmaceutical Co., Ltd.
• Public title: Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose of ZSP1603 in Healthy Adults
• Scientific title: A Phase 1 Randomized,Double-Blind,Parallel-Group, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ZSP1603 in Chinese Healthy Subjects
• Date of first enrolment: July 16, 2018
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03619616
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

China

Contacts

• Name: Guoping Yang, MD
• Affiliation: The Third Xiangya Hospital of Central South University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects are required to meet the following criteria in order to be included in the
trial:

1. Males and female subjects between 18-50 years (Both inclusive).

2. 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).

3. 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.

4. 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.

5. 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:

1. 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;

2. Known hypersensitivity and/or allergy to some drugs and food,especially for the
composition that is similar to the investigative product;

3. Subjects who have received a surgery within 4 weeks prior to the test or who plan
to perform a surgery during the study;

4. Use of any drugs or health care products (including herbs) within 14 days prior
to screening.

5. 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 ).

6. Participated in another clinical research study and received any other
investigational products within 3 months prior to dosing.

7. Subjects who donated blood or bleeding profusely(= 200 mL), received blood
transfusion or use of blood products in the 3 months preceding study screening.

8. 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.

9. Subjects who have special dietary habit and inability to consume the food
provided in the study;

10. Subjects who could not tolerate venipuncture;

11. Dysphagia of capsule;

12. Frequently drinks tea, coffee and/or caffeinated beverages(more than 8 cups, 1
cup =250 mL) per day ;

13. Daily consuming more than 5 cigarettes within 3 months prior to screening or
cannot stop using any tobacco products during the trial.

14. 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 ;

15. 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.

16. 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.

17. 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.

18. Subjects who may not complete the study for other reasons or should not be
included in the study in the opinion of the Investigator.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Solid Tumor

Idiopathic Pulmonary Fibrosis(IPF)

Intervention(s)

Drug: Placebo 12.5mg

Drug: ZSP1603 25 mg

Drug: ZSP1603 50 mg

Drug: ZSP1603 7.5 mg

Drug: Placebo 25mg

Drug: Placebo 50mg

Drug: ZSP1603 12.5 mg

Primary Outcome(s)

Number of participants with treatment-emergent adverse events (TEAEs) following oral doses of ZSP1603 and placebo,separately. [Time Frame: At Day 6 post-dose.]

Secondary Outcome(s)

AUClast(AUC0-t)of ZSP1603 [Time Frame: Up to 6 days post-dose]

MRT of ZSP1603 [Time Frame: Up to 6 days post-dose]

AUC0-24 of ZSP1603 [Time Frame: Up to 6 days post-dose]

CL/F of ZSP1603 [Time Frame: Up to 6 days post-dose]

t1/2 of ZSP1603 [Time Frame: Up to 6 days post-dose]

Cmax of ZSP1603 [Time Frame: Up to 6 days post-dose]

Tmax of ZSP1603 [Time Frame: Up to 6 days post-dose]

?z of ZSP1603 [Time Frame: Up to 6 days post-dose]

VD/F of ZSP1603 [Time Frame: Up to 6 days post-dose]

Secondary ID(s)

XY3-PK-ZSP1603

Source(s) of Monetary Support

Please refer to primary and secondary sponsors