Healthy
Conditions
Keywords
HSK47388, Phase I
Brief summary
This is a single-center, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability and PK of HSK47388 in healthy adult participants and preliminarily evaluate the PD of HSK47388
Interventions
DRUGPlacebo
cohort 1 to cohort 5
DRUGHSK47388
cohort 1 to cohort 5
Sponsors
Haisco Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects. 2. Adult males and females between ≥ 18 and ≤ 55 years (inclusive) at Screening. 3. Able and willing to attend the necessary visits to the study site
Exclusion criteria
1. Participants with any disease history that may affect the safety evaluation or in vivo process of IP as judged by the PI or delegate, including central nervous, cardiovascular, digestive, respiratory, urinary, blood, immune and endocrine diseases. Participants with childhood asthma (resolved) can be included at the discretion of the PI. 2. Underlying physical or psychological medical condition that, in the opinion of the PI or delegate, would make the participant unlikely to comply with the protocol or complete the study per protocol. 3. Participants who may not be able to complete the study for other reasons, cannot comply with the requirements of the study, or are unsuitable to participate in the study as judged by the PI or delegate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE | 7 days after single dose | The incidence, severity, and relationship to IP of AEs. Change from Baseline in clinical laboratory parameters (ie, hematology, serum chemistry, coagulation, and urinalysis parameters), physical examination findings, vital signs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | Predose up to Day 5 postdose | Maximum concentration |
| Tmax | Predose up to Day 5 postdose | Time to maximum concentration |
| AUC | Predose up to Day 5 postdose | Area under the drug concentrationtime curve |
| t1/2 | Predose up to Day 5 postdose | Apparent terminal half-life |
| CL/F | Predose up to Day 5 postdose | Apparent total plasma clearance of drug |
Countries
Australia
Contacts
Primary ContactRedzepagic Emir
Outcome results
None listed