NCT02426151

Brief Summary

To Compare Pharmacokinetic and Pharmacodynamic Profiles of BEPO-A and REPO-A in Healthy Male Subjects

Trial Health

100
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Apr 2015

Typical duration for phase_1 healthy

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

April 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2015

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

March 18, 2016

Status Verified

April 1, 2015

Enrollment Period

1 month

First QC Date

April 21, 2015

Last Update Submit

March 17, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Cmax and AUClast

    1D before dosing, 1h, 2, 4h, 7h, 10h,12h, 14h, 2D 0h, 2D 8h, 3D 0h, 4D 0h, 5D 0h, 6D 0h,

Secondary Outcomes (1)

  • AUCinf, Tmax, t1/2β, CL/F, MRTinf (mean residence time) of Erythropoietin

    1D before dosing, 1h, 2, 4h, 7h, 10h,12h, 14h, 2D 0h, 2D 8h, 3D 0h, 4D 0h, 5D 0h, 6D 0h,

Study Arms (2)

BEPO-A

EXPERIMENTAL

Single subcutaneous injection of BEPO-A 4000 IU (Bioreactor manufacturing process)

Drug: BEPO-A

REPO-A

ACTIVE COMPARATOR

Single subcutaneous injection of REPO-A 4000 IU (Roller bottle manufacturing process)

Drug: REPO-A

Interventions

BEPO-ADRUG

BEPO-A (Bioreactor manufacturing process)

BEPO-A
REPO-ADRUG

REPO-A (Roller bottle manufacturing process)

REPO-A

Eligibility Criteria

Age19 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Agree to all the purposes of the study by signing and dating the Informed Consent;
  • Male, aged between 19 and 40 years, clinically healthy;
  • BMI between 19 and 28;
  • mmHg ≤ SBP \<140 mmHg, 50 mmHg ≤ DBP \< 85 mmHg

You may not qualify if:

  • Hemoglobin \<13 g / dL
  • Ferritin \<20 ng/mL or TIBC \> 360 ug/ dL
  • Vitamin B12 \< 200 pg/mL or floate \< 4 ng/mL
  • %reticulpcyte \> 3%
  • platelet \< 100,000/ul or \> 400,000/ul
  • GFR \< 60mL/min/1.73m2
  • Going to or during treatment of the tumor
  • Clinical history of allergy of biological products derived from mammalian albumin or any component of the formulation
  • Clinical history of autoimmune or hereditary anemia
  • A Positive reaction in the nicotine tests
  • Principal Investigator of the study criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

April 21, 2015

First Posted

April 24, 2015

Study Start

April 1, 2015

Primary Completion

May 1, 2015

Study Completion

September 1, 2015

Last Updated

March 18, 2016

Record last verified: 2015-04

Data Sharing

IPD Sharing
Will not share