A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UB-921 in Healthy Volunteers

April 2, 2019 updated by: United BioPharma

Open-label, Two-part, Dose-escalation and Comparative Pharmacokinetics Study of UB-921 in Healthy Male Volunteers

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, two-part, dose-escalation and comparative pharmacokinetics study of UB-921 in healthy male volunteers. There will be two parts: dose escalation study (Main Study) and comparative pharmacokinetics study (Sub-study).

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Prime site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: UB-921 2 mg/kg (Main-study)
Intravenous infusion
Biological: UB-921
150 mg/vial
EXPERIMENTAL: UB-921 6 mg/kg (Main-study)
Intravenous infusion
Biological: UB-921
150 mg/vial
EXPERIMENTAL: UB-921 8 mg/kg (Main-study)
Intravenous infusion
Biological: UB-921
150 mg/vial
EXPERIMENTAL: UB-921 6 mg/kg (Sub-study)
Intravenous infusion
Biological: UB-921
150 mg/vial
ACTIVE_COMPARATOR: Herceptin 6 mg/kg (Sub-study)
Intravenous infusion
Biological: Herceptin
440 mg/vial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse event incidence
Time Frame: 63 days
from the baseline to the end of study visit
63 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United BioPharma

Collaborators

Tri-Service General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 5, 2018

Primary Completion (ACTUAL)

October 8, 2018

Study Completion (ACTUAL)

April 2, 2019

Study Registration Dates

First Submitted

January 2, 2017

First Submitted That Met QC Criteria

January 5, 2017

First Posted (ESTIMATE)

January 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 3, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UBP-A103-HER2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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