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

Shanghai HEP Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Hepatitis B， Chronic

Treatments: Drug: Hepalatide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02612506

L47-Ia-01

Details and patient eligibility

About

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

Full description

This is a randomized, double-blinded, dose escalating, phase Ia trial, which will be conducted in No. 302 Hospital of China. There are seven cohorts at dose of 0.21mg, 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg. The first cohort with 0.21mg is an open test with no placebo as control. All other healthy volunteers will be randomized into Hepalatide or placebo group at 4:1 rate, and will be received drug by abdominal subcutaneous injection and will be observed for 8 days.

Enrollment: 48 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups, including a placebo group

Hepalatide

Experimental group

Description:

Hepalatide 0.21mg, 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg

Treatment:

Drug: Hepalatide

Placebo

Placebo Comparator group

Description:

Placebo 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg

Treatment:

Drug: Placebo