To evaluate the safety and tolerability of Hepalatide(L47) and characterize the clinical
pharmacokinetics in healthy volunteers.
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Full eligibility criteria for NCT03023787
Ages eligible for Study
18 Years to 45 Years
Genders eligible for Study
Accepts Healthy Volunteers
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
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.
All locations for NCT03023787
302 Military Hospital
View full eligibility
Tris trial is registered with FDA with number: NCT03023787. The sponsor of the trial is Shanghai HEP Pharmaceatical Co., Ltd. and it is looking for 35 volunteers for the current phase.
Official trial title: A Randomized, Double-Blinded, Safety and Pharmacokinetic Study of Escalating Single Doses of Hepalatide in Healthy Volunteers
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