NCT03199261

Brief Summary

Evaluation of the pharmacokinetics and safety rE-4 Injection versus rE-4 Freeze-dried Powder in healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 type-2-diabetes

Timeline
Completed

Started Dec 2016

Shorter than P25 for phase_1 type-2-diabetes

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

December 23, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2017

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 26, 2017

Completed
Last Updated

June 26, 2017

Status Verified

December 1, 2016

Enrollment Period

29 days

First QC Date

January 17, 2017

Last Update Submit

June 23, 2017

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Bioequivalency between the 2 formulations of rE-4

    Area under curve

    before injection and 0.25,0.5,0.75,1.0,1.5，2.0,3.0,4.0,6.0,8.0hour post-injection

Study Arms (2)

rE-4 Injection

EXPERIMENTAL

10µg, rE-4 Injection, 30 minutes prior to the start time of a standard breakfast.

Drug: rE-4 Injection

rE-4 Freeze-dried Powder

ACTIVE COMPARATOR

10µg, rE-4 Freeze-dried Powder, 30 minutes prior to the start time of a standard breakfast.

Drug: rE-4 Freeze-dried Powder

Interventions

rE-4 InjectionDRUG

During the study session, healthy subjects will be receive a subcutaneous single dose of rE-4 Injection 10µg administered 30 minutes prior to the start time of a standard breakfast.

Also known as: Recombinant Exendin-4 Injection
rE-4 Injection
rE-4 Freeze-dried PowderDRUG

During the study session, healthy subjects will be receive a subcutaneous single dose of rE-4 Freeze-dried Powder 10µg administered 30 minutes prior to the start time of a standard breakfast.

Also known as: Recombinant Exendin-4 Freeze-dried Powder
rE-4 Freeze-dried Powder

Eligibility Criteria

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

You may qualify if:

  • Healthy male adult volunteers of 18-45 years old, who can be inserted needle.
  • Body mass index (BMI) of 19 to 26 kg/m2, inclusive BMI = weight (kg)/\[height(m)\]2，During Screening period body weight≥50 kg.
  • Subjects are fully informed and voluntarily consent to participate in this study.

You may not qualify if:

  • A positive result in hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test.
  • History or presence of neurological, cardiovascular, renal, hepatic, pancreatic,gastrointestinal, pulmonary, metabolic, or musculoskeletal diseases.
  • History or presence neurological disorder disease.
  • Abnormal laboratory profiles, routine inspection, vitl signs and ECGs results with clinical significance.
  • Participation in a clinical drug study 30 days prior to present study.
  • FPG≥6.1mmol/L or \<3.9mmol/L.
  • SBP\<90mmHg or \>140mmHg; DBP\>90mmHg.
  • Use of any other drugs,vitamine and mineral substance.
  • Blood donation more than 200 mL blood within 3 months prior to the study.
  • Smoker (\>5 cigarettes/day) or alcoholist (355 ml alcohol/day).
  • History or Family history of hypoglycemia.
  • History of allergy or hypersensitivity.
  • Subjects planning to give birth or donate sperm during the study or within 3 months after the study.
  • Other unfavorable factors diagnosed by investigators.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital Military Medical Sciences

Beijing, 100071, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Hengyan Qu, Ph.D

    The Affiliated Hospital Military Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2017

First Posted

June 26, 2017

Study Start

December 23, 2016

Primary Completion

January 21, 2017

Study Completion

January 21, 2017

Last Updated

June 26, 2017

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)