Study of HX15001 in Adult Healthy Volunteers.
Trial Parameters
Brief Summary
This is a phase I, randomized, double-blinded, placebo-controlled, single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetic characteristics and pharmacodynamics of HX15001 in adult healthy participants. The study consists of two parts: Part A involves single-dose escalation (Cohorts 1-7), and Part B involves multiple-dose escalation (Cohorts 8-9). The primary objective of this study is to characterize the safety and tolerability of single and multiple doses of HX15001 in healthy subjects.
Eligibility Criteria
Inclusion Criteria: 1. An informed consent document signed and dated by the subject. 2. Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive. 3. Have a Body mass index (BMI) of 18-32 kg/m2 , inclusive; with body weight ≥50 kg during the screening. 4. In good health, as determined by the investigator at Screening procedures, with no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations. 5. Subjects must be willing to understand and comply with all research procedures and restrictions, and able to communicate effectively with researchers. Exclusion Criteria: 1. Females who are pregnant, planning to become pregnant, or breastfeeding during the trial. 2. Has a positive result of pregnancy test at Screening or Baseline 3. History of HIV infection, hepatitis B, hepatitis C or syphilis; positive testing for HIV, hepatitis B, HCV Ab or serological rea