Loading clinical trials...
Loading clinical trials...
A Randomized, Double-Blinded, Safety and Pharmacokinetic Study of Escalating Single Doses of Hepalatide in Healthy Volunteers
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.
Age
18 - 45 years
Sex
ALL
Healthy Volunteers
Yes
302 Military Hospital
Beijing, Beijing Municipality, China
Start Date
October 1, 2015
Primary Completion Date
August 1, 2016
Completion Date
August 1, 2016
Last Updated
February 14, 2017
48
ACTUAL participants
Hepalatide
DRUG
Placebo
DRUG
Lead Sponsor
Shanghai HEP Pharmaceutical Co., Ltd.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions