Idiopathic Pulmonary Fibrosis(IPF), Solid Tumor
Conditions
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.
Detailed description
This is a Phase 1, double-blinded, placebo-controlled, single center study aimed at investigating the safety, tolerability and the pharmacokinetics of ZSP1603 on fasted condition.Up to 4 cohorts of 32 eligible participants totally are planned to be enrolled. This is a two-arm clinical trial that ZSP1603 and matching placebo will be orally administered once daily. Two subjects in the first cohort will be assigned in a opened fashion to receive 7.5mg of ZSP1603 while another three cohorts of volunteers will be randomly assigned in a blinded fashion to receive either a single dose of ZSP1603 or matching placebo in an ascending dose fashion. To monitor AEs,record abnormalities (Holter, 12-lead ECG, Vital signs, Physical examination, Clinical Laboratory), and detect the pharmacokinetics of ZSP1603.
Interventions
DRUGZSP1603 7.5 mg
ZSP1603 capsule administered orally once daily under fasted condition.
DRUGZSP1603 12.5 mg
ZSP1603 capsule administered orally once daily in the fasting state.
DRUGPlacebo 12.5mg
Participants will receive placebo matching to ZSP1603 orally once daily under fasted condition.
DRUGZSP1603 25 mg
ZSP1603 capsule administered orally once daily under fasted condition.
DRUGPlacebo 25mg
Participants will receive placebo matching to ZSP1603 orally once daily in the fasting state.
DRUGZSP1603 50 mg
ZSP1603 capsule administered orally once daily under fasted state.
DRUGPlacebo 50mg
Participants will receive placebo matching to ZSP1603 orally once daily in the fasting state.
Sponsors
Guangdong Zhongsheng Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Triple(Participant, Investigator, Clinical Research Associate)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-emergent adverse events (TEAEs) following oral doses of ZSP1603 and placebo,separately. | At Day 6 post-dose. | Number of participants with TEAEs as assessed by CTCAE v5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-24 of ZSP1603 | 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). |
| Cmax of ZSP1603 | Up to 6 days post-dose | Cmax is defined as the maximum observed concentration of drug in plasma. |
| Tmax of ZSP1603 | Up to 6 days post-dose | Tmax is defined as the time to maximum concentration. |
| t1/2 of ZSP1603 | Up to 6 days post-dose | t1/2 is defined as the time to half of the drug concentration in plasma. |
| AUClast（AUC0-t）of ZSP1603 | Up to 6 days post-dose | AUClast is defined as the concentration of drug from time zero to the last quantifiable concentration. |
| λz of ZSP1603 | Up to 6 days post-dose | λz is defined as the ratio between the elimination of compound per unit time and the total amount of compound. |
| VD/F of ZSP1603 | Up to 6 days post-dose | VD/F is defined as apparent volume of distribution |
| MRT of ZSP1603 | Up to 6 days post-dose | MRT is defined as mean residence time |
| CL/F of ZSP1603 | Up to 6 days post-dose | CL/F is defined as the ratio of total clearance(CL) to bioavailability(F). |
Countries
China
Outcome results
None listed