Study of Hepalatide(L47) at Phase Ib in Healthy Volunteers

Shanghai HEP Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Hepatitis B， Chronic

Treatments: Drug: Placebo; Drug: Hepalatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT03023787

L47-Ib-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 Ib trial, which will be conducted in No. 302 Hospital of China. There are three cohorts at dose of 4.2mg, 6.3mg and 8.4mg. All healthy volunteers will be randomized into Hepalatide or placebo group at 4:1 rate, all healthy volunteers will be received treatment drug by abdominal subcutaneous injection once a day for seven days and will be observed for 3 days.

Enrollment: 35 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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35 participants in 2 patient groups, including a placebo group

Hepalatide

Experimental group

Description:

Hepalatide 4.2mg, 6.3mg and 8.4mg

Treatment:

Drug: Hepalatide

Placebo

Placebo Comparator group

Description:

Placebo 4.2mg, 6.3mg and 8.4mg

Treatment:

Drug: Placebo