NCT03013881

Brief Summary

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single-dose of UB-921 in healthy male volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2018

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

First Submitted

Initial submission to the registry

January 2, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
1.2 years until next milestone

Study Start

First participant enrolled

March 5, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2019

Completed
Last Updated

April 3, 2019

Status Verified

April 1, 2019

Enrollment Period

7 months

First QC Date

January 2, 2017

Last Update Submit

April 2, 2019

Conditions

Breast Neoplasm

Keywords

UB-921anti-HER2 monoclonal antibodybreast neoplasmbreast cancerHerceptinTrastuzumabHER2

Outcome Measures

Primary Outcomes (1)

  • Adverse event incidence

    from the baseline to the end of study visit

    63 days

Study Arms (5)

UB-921 2 mg/kg (Main-study)

EXPERIMENTAL

Intravenous infusion

Biological: UB-921

UB-921 6 mg/kg (Main-study)

EXPERIMENTAL

Intravenous infusion

Biological: UB-921

UB-921 8 mg/kg (Main-study)

EXPERIMENTAL

Intravenous infusion

Biological: UB-921

UB-921 6 mg/kg (Sub-study)

EXPERIMENTAL

Intravenous infusion

Biological: UB-921

Herceptin 6 mg/kg (Sub-study)

ACTIVE COMPARATOR

Intravenous infusion

Biological: Herceptin

Interventions

UB-921BIOLOGICAL

150 mg/vial

UB-921 2 mg/kg (Main-study)UB-921 6 mg/kg (Main-study)UB-921 6 mg/kg (Sub-study)UB-921 8 mg/kg (Main-study)
HerceptinBIOLOGICAL

440 mg/vial

Herceptin 6 mg/kg (Sub-study)

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Total body weight ≧50 kg (110 lbs)
  • No clinically relevant abnormalities
  • To agree on using birth control barrier (eg. male condom) during the entire study period.
  • Signing the written informed consent form

You may not qualify if:

  • Previous exposure to chimeric, humanized or human monoclonal antibody, whether licensed or investigational
  • A history of drug abuse or heavy drinking.
  • Blood donation over 250 mL within 90 days prior to the screening
  • Not in the condition to participate in this study considered by investigator(s)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prime site

Taipei, Taiwan

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Hsiang-Cheng Chen

    Tri-Service General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 2, 2017

First Posted

January 9, 2017

Study Start

March 5, 2018

Primary Completion

October 8, 2018

Study Completion

April 2, 2019

Last Updated

April 3, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)