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

NCT03619616 | Completed Phase 1

• 1 other identifier: XY3-PK-ZSP1603
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The Primary objectives of this study are to evaluate the safety and tolerability of ZSP1603 and the Secondary objective is to estimate the pharmacokinetic (PK) parameters after orally administered once daily of ZSP1603.

Conditions

Idiopathic Pulmonary Fibrosis(IPF); Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-emergent adverse events (TEAEs) following oral doses of ZSP1603 and placebo,separately.

  Number of participants with TEAEs as assessed by CTCAE v5.0.

  At Day 6 post-dose.

Secondary Outcomes (9)

• AUClast（AUC0-t）of ZSP1603

  Up to 6 days post-dose

• AUC0-24 of ZSP1603

  Up to 6 days post-dose

• Cmax of ZSP1603

  Up to 6 days post-dose

• Tmax of ZSP1603

  Up to 6 days post-dose

• t1/2 of ZSP1603

  Up to 6 days post-dose

Study Arms (4)

ZSP1603 (single dose)-7.5 mg (Cohort 1)

EXPERIMENTAL

Subject adminsitered at a dose of ZSP1603 7.5 mg on day 1 under fasted condition.

Drug: ZSP1603 7.5 mg

ZSP1603 (single dose)-12.5mg (Cohort 2)

EXPERIMENTAL

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.

Drug: ZSP1603 12.5 mg; Drug: Placebo 12.5mg

ZSP1603 (single dose)-25 mg (Cohort 3)

EXPERIMENTAL

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.

Drug: ZSP1603 25 mg; Drug: Placebo 25mg

ZSP1603 (single dose)-50 mg (Cohort 4)

EXPERIMENTAL

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.

Drug: ZSP1603 50 mg; Drug: Placebo 50mg

Interventions

ZSP1603 7.5 mg DRUG

ZSP1603 capsule administered orally once daily under fasted condition.

ZSP1603 (single dose)-7.5 mg (Cohort 1)

ZSP1603 12.5 mg DRUG

ZSP1603 capsule administered orally once daily in the fasting state.

ZSP1603 (single dose)-12.5mg (Cohort 2)

Placebo 12.5mg DRUG

Participants will receive placebo matching to ZSP1603 orally once daily under fasted condition.

ZSP1603 (single dose)-12.5mg (Cohort 2)

ZSP1603 25 mg DRUG

ZSP1603 capsule administered orally once daily under fasted condition.

ZSP1603 (single dose)-25 mg (Cohort 3)

Placebo 25mg DRUG

Participants will receive placebo matching to ZSP1603 orally once daily in the fasting state.

ZSP1603 (single dose)-25 mg (Cohort 3)

ZSP1603 50 mg DRUG

ZSP1603 capsule administered orally once daily under fasted state.

ZSP1603 (single dose)-50 mg (Cohort 4)

Placebo 50mg DRUG

Participants will receive placebo matching to ZSP1603 orally once daily in the fasting state.

ZSP1603 (single dose)-50 mg (Cohort 4)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Zhongsheng Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Guoping Yang, MD

  The Third Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple(Participant, Investigator, Clinical Research Associate)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: August 8, 2018
• Study Start: July 16, 2018
• Primary Completion: June 28, 2019
• Study Completion: October 22, 2019
• Last Updated: October 23, 2019

Record last verified: 2019-10

Locations

CN (1)