The goal of this clinical trial is to evaluate the safety, tolerability and pharmacokinetic characteristics of CL-197 capsules in health conditions.
In this trial, 46 healthy participants will be enrolled, 6 healthy participants in 1mg group, 40 healthy participants distributed equally in other four groups: 10mg group, 30mg group, 60mg group and 100mg group, including thier respective placebo control groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
44
Single oral dose of 1 mg CL-197 capsules or CL-197 placebo administered following ≥10 hour fast
Single oral dose of 10 mg CL-197 capsules or CL-197 placebo administered following ≥10 hour fast
Single oral dose of 30 mg CL-197 capsules or CL-197 placebo administered following ≥10 hour fast
The Fifth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
The Safety and Tolerability of CL-197 Capsules :Incidence of Treatment-Emergent Adverse Events as Assessed by The NCI CTCAE V5.0 Grading Criteria
The degree of adverse events observed in the trial would be determined by the NCI CTCAE v5.0 grading criteria, and the adverse events related to the test drug (definitely related, likely to be related, and possibly related) would be terminated in the following cases, and the previous dose would be used as the MTD of the single-dose tolerance test.
Time frame: Up to 29 days post-dose
The Peak Plasma Concentration (Cmax) of CL-197 Capsules
The index components in human blood samples would be measured by LC-MS/MS, and the peak plasma concentration (Cmax) would be calculated.
Time frame: Up to 672 hours post-dose in 30mg group and 60 mg group; Up to 162 hours post-dose in other groups
The Area Under the Plasma Concentration Versus Time Curve (AUC) of CL-197 Capsules
The index components in human blood samples would be measured by LC-MS/MS, and the area under the plasma concentration versus time curve (AUC) would be calculated.
Time frame: Up to 672 hours post-dose in 30mg group and 60 mg group; Up to 162 hours post-dose in other groups
The Elimination Half-Life (t1/2) of CL-197 Capsules
The index components in human blood samples would be measured by LC-MS/MS, and the elimination half-life (t1/2) would be calculated.
Time frame: Up to 672 hours post-dose in 30mg group and 60 mg group; Up to 162 hours post-dose in other groups
The Accumulate Urinary Drug Excretion (Ae) of CL-197 Capsules
The index components in human urine samples would be measured by LC-MS/MS, and the accumulate urinary drug excretion (Ae) would be calculated.
Time frame: Up to 672 hours post-dose in 30mg group and 60 mg group; Up to 162 hours post-dose in other groups
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Single oral dose of 60 mg CL-197 capsules or CL-197 placebo administered following ≥10 hour fast
Single oral dose of 100 mg CL-197 capsules or CL-197 placebo administered following ≥10 hour fast