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

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

October 31, 2015

Primary Completion Date

August 31, 2016

Study Completion Date

August 31, 2016

Conditions
Hepatitis B, Chronic
Interventions
DRUG

Hepalatide

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.

DRUG

Placebo

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.

Trial Locations (1)

100039

302 Military Hospital, Beijing

All Listed Sponsors
lead

Shanghai HEP Pharmaceutical Co., Ltd.

INDUSTRY

NCT02612506 - Safety and Pharmacokinetic Study of Hepalatide(L47) in Healthy Volunteers | Biotech Hunter | Biotech Hunter