Safety and Pharmacokinetic Study of Hepalatide(L47) in Healthy Volunteers

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and tolerability of Hepalatide(L47) and characterize the clinical pharmacokinetics in healthy volunteers.

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

Details

• Lead Sponsor: Shanghai HEP Pharmaceatical Co., Ltd.

Criteria

Inclusion Criteria:

• Ages between 18 and 45 years

• BMI Index between 19 and 25 (BMI=weight/height2)

• Normal previous history and physical exam

• No drug and alcohol abuse

• No illness in 4 weeks and no drug therapy in 2 weeks

• No blood donation or subject not sampled in 3 months

• Consistent and correct use of recommended methods of birth control for men and women

• Good compliance with study protocol

• Understand and agree to sign a consent form

Exclusion Criteria:

• Infection with HAV, HBV, HCV, HEV, HIV, EBV or CMV

• Abnormal and clinical significance test of physical examination, vital signs, blood routines, urine routines, liver and kidney functions, coagulation indicator, electrolyte, glucose, blood lipid, thyroid functions, chest X-Ray, ECG, B ultrasound of gallbladder, spleen and kidney, AFP ,and CEA

• Positive for anti-Pre-S1 antibody

• Women being pregnant or nursing, or with abnormal sex hormones, B ultrasound of ovaries/uterus proliferative diseases or breast mass

• Unable to quit smoking in trial

• Subject with little chance of enrollment (i.e. the weak)

• Subject not suitable to join the trial under other circumstances judged by investigator.