This single-center, randomized, double-blind, placebo-controlled, two-part study is designed to assess the safety, tolerability and PK of oral HL-1186 Tablet in healthy participants.
Healthy participants, males and females.
Between the ages of 18 and 45 years old (inclusive).
Weighs no less than 50 kg (for males) or 45 kg (for females) and body mass index (BMI) within 19.0 to 26.0 kg/m2 (inclusive).
During the screening period, vital signs, physical examination, blood routine, blood biochemistry, coagulation function, urine routine, virology examination, chest X-ray, and pregnancy blood test (female) were examined, and the results did not show abnormalities or abnormalities without clinical significance.
Females who are pregnant or breastfeeding; females/males who are prepared for having children.
History or presence of neurological, cardiovascular, renal, hepatic, gastrointestinal, respiratory, hematological, endocrine, or osteoarticular disorders, or any laboratory abnormalities that pose a potential danger to constitute a risk when taking the study intervention or interfere with the interpretation of data.
Active infectious diseases which need anti-infection treatment.
Significant surgery within three months and not fully recovered per investigator's judgments.
Parallel
HL-1186
DrugHL-1186 tablet for oral administration.
HL-1186 placebo
DrugHL-1186 placebo tablet for oral administration.
To assess the safety and tolerability of single and multiple doses of HL-1186 in healthy participants
Number of participants with adverse events, with abnormal physical examination finding, with abnormal vital signs, abnormal 12-lead electrocardiograms and abnormal laboratory tests results (hematology, urinalysis, clinical chemistry, coagulation function
To assess the pharmacokinetic parameters of HL-1186 in healthy participants
Time to reach maximum concentration (Tmax)
To assess the pharmacokinetic parameters of HL-1186 in healthy participants
Maximum concentration (Cmax)
To assess the pharmacokinetic parameters of HL-1186 in healthy participants
Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration (AUC0-t)
To assess the pharmacokinetic parameters of HL-1186 in healthy participants
Elimination half time (T1/2)
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