NCT01504581

Brief Summary

Study design: This is a randomized, double-blind, placebo- and active-controlled, single-dose study in 4 groups of 12 healthy male subjects each. In each group, 8 subjects will receive a dose of HM10660A, 2 subjects will receive a single dose of placebo and 2 subjects will receive a single dose of a currently marketed PEG-interferon.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy

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

March 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 5, 2012

Completed
Last Updated

February 7, 2014

Status Verified

February 1, 2014

Enrollment Period

6 months

First QC Date

December 27, 2011

Last Update Submit

February 6, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Number of participants with AE occurrence, clinically significant clinical lab, vital sign, and/or ECG change

    Number of participants with AE occurrence, clinically significant clinical lab, vital sign, and/or ECG change among HM10660A receivers will be assessed. It can be compared to those numbers in Active comparator group.

    43 days

Study Arms (3)

HM10660A

EXPERIMENTAL
Biological: HM10660A

Pegasys

ACTIVE COMPARATOR
Biological: Pegasys

HM10660A Placebo

PLACEBO COMPARATOR
Biological: HM10660A placebo

Interventions

HM10660ABIOLOGICAL

Single dose of HM10660A 1.5, 2.25, 3.0, or 4.0 ug/kg

HM10660A
HM10660A placeboBIOLOGICAL

Single dose of HM10660A Placebo

HM10660A Placebo
PegasysBIOLOGICAL

Single dose of Pegasys 180ug

Pegasys

Eligibility Criteria

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

You may qualify if:

  • Age: 18 - 45 Years, Inclusive
  • BMI: 18.0 - 28.0 kg/m2
  • Are Non-smokers or Smoker of Fewer Than 5 Cigarettes Per Day as Determined by History

You may not qualify if:

  • Mental Handicap
  • Evidence of Clinically Relevant Pathology
  • History of Type 1 Diabetes or Thyroid Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanmi clinical

Netherlands, Netherlands

Location

MeSH Terms

Interventions

peginterferon alfa-2a

Study Design

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

Study Record Dates

First Submitted

December 27, 2011

First Posted

January 5, 2012

Study Start

March 1, 2011

Primary Completion

September 1, 2011

Last Updated

February 7, 2014

Record last verified: 2014-02

Locations

NL(1)