Multiple Dose Safety, Tolerability, PK，PD and Food Effect Study of HEC96719 in Healthy Adult Subjects

• Status: Completed
• Trial end date: 2020-12-29
• Target enrollment: 0
• Participant gender: All

Summary

The Safety, Tolerability, Pharmacokinetic, Pharmacodynamics and Food Effect Study of HEC96719 in Healthy Subjects

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

Details

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

Criteria

Inclusion Criteria:

• Willing to participate in the study, able to understand and sign the informed consent, and able to complete the the study in accordance with the requirements of the study.

• Female subjects who are not pregnant or lactating and male subjects whose female partners are fertile shall voluntarily take effective contraceptive measures from the date of signing the informed consent form to 3 months after the medication.

• When signing the informed consent, 18 years old ≤the age≤45 years old(including the critical value), gender is not limited.

• Male body weight ≥50kg, female body weight ≥45kg, and body mass index (BMI) in the range of 18-28 kg/m2 (including the critical value).

• No clinical significance of vital signs, physical examination, laboratory examination, electrocardiogram, ultrasound abdomen and chest X-ray (posterior and anterior) results.

Exclusion Criteria:

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

• Those who are known to have allergy history or allergy constitution to the test preparation and any of its components or related preparations.

• Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.

• Positive results from urine drug screen test.

• Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.

• Subjects who plan to receive or have had organ transplants.

• Subjects considered by the investigator to have other factors unsuitable for participation in this study.