A Phase 1 interventional study of Hepalatide and Placebo in Hepatitis B， Chronic, sponsored by Shanghai HEP Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-14.
Sponsored by Shanghai HEP Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment
To evaluate the safety and tolerability of Hepalatide(L47) and characterize the clinical pharmacokinetics in healthy volunteers.
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.
Exclusion Criteria:
Hepalatide 0.21mg, 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg
Drug: Hepalatide
Placebo 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg
Drug: Placebo
There are seven cohorts as follows 0.21mg, 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg. Dose of 0.21mg is a pilot trial with no placebo. At each dose level, healthy volunteers will be received treatment drug by abdominal subcutaneous injection at the first day and monitored for 8 days.
Also known as: treatment drug
There are six cohorts as follows 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg. At each dose level, healthy volunteers will be received control drug by abdominal subcutaneous injection at the first day and monitored for 8 days.
Also known as: control drug
Healthy participants with treatment-related adverse events as assessed by "guiding principle of grading standards for the adverse reactions in clinical trials of vaccine for prevention" or CTCAE v4.0
Time frame: half a year
Maximum Plasma Concentration (Cmax)
Time frame: half a year
Area under the plasma concentration versus time curve (AUC)
Time frame: half a year
half-time
Time frame: half a year
apparent volume of distribution
Time frame: half a year
Plan to share: No
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This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Shanghai HEP Pharmaceutical Co., Ltd.