NCT03023787

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
Last Updated

January 23, 2017

Status Verified

January 1, 2017

Enrollment Period

4 months

First QC Date

January 15, 2017

Last Update Submit

January 20, 2017

Conditions

Hepatitis B， Chronic

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Secondary Outcomes (4)

  • Maximum Plasma Concentration (Cmax)

    6 months

  • Area under the plasma concentration versus time curve (AUC)

    6 months

  • half-time

    6 months

  • apparent volume of distribution

    6 months

Study Arms (2)

Hepalatide

EXPERIMENTAL

Hepalatide 4.2mg, 6.3mg and 8.4mg

Drug: Hepalatide

Placebo

PLACEBO COMPARATOR

Placebo 4.2mg, 6.3mg and 8.4mg

Drug: Placebo

Interventions

HepalatideDRUG

There are three cohorts as follows 4.2mg, 6.3mg, 8.4mg. At each dose level, healthy volunteers will be received treatment drug by abdominal subcutaneous injection once a day for seven days and will be monitored for 3 days.

Also known as: treatment drug
Hepalatide
PlaceboDRUG

There are three cohorts as follows 4.2mg, 6.3mg, 8.4mg. At each dose level, healthy volunteers will be received control drug by abdominal subcutaneous injection once a day for seven days and will be monitored for 3 days.

Also known as: control drug
Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

302 Military Hospital

Beijing, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Drug and Narcotic Control

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Legislation, DrugLegislation as TopicSocial Control, FormalHealth Care Economics and OrganizationsPharmacy AdministrationOrganization and AdministrationHealth Services Administration

Study Officials

  • zhenman wei

    302 Military Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2017

First Posted

January 18, 2017

Study Start

August 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 23, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)