The Tolerability and Pharmacokinetics Study of HEC110114 Tablets in Healthy Adult Subjects

• Status: Completed
• Trial end date: 2019-10-29
• Target enrollment: 0
• Participant gender: All

Summary

A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of HEC110114 Tablets in Healthy Adult Subjects

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

Criteria

Inclusion Criteria:

• Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions

• Be able to complete the study according to the trail protocol

• Subjects (including partners) have no pregnancy plan within six months after the last dose of study drug and voluntarily take effective contraceptive measures

• Male subjects and must be 18 to 45 years of age inclusive

• Body weight ≥ 50 kg and body mass index（BMI）between 18 and 28 kg/m2, inclusive

• Physical examination and vital signs without clinically significant abnormalities.

Exclusion Criteria:

• Use of >5 cigarettes per day during the past 3 months

• Allergies constitution ( multiple drug and food allergies)

• History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine)

• Donation or loss of blood over 450 mL within 3 months prior to screening

• 12-lead ECG with clinically significant

• Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis

• Subjects deemed unsuitable by the investigator for any other reason.