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

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ClinicalTrials.gov Identifier: NCT03013881
Recruitment Status : Completed
First Posted : January 9, 2017
Last Update Posted : April 3, 2019
Sponsor:
Collaborator:
Tri-Service General Hospital
Information provided by (Responsible Party):
United BioPharma

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.

Condition or disease Intervention/treatment Phase
Breast Neoplasm Biological: UB-921 Biological: Herceptin Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Two-part, Dose-escalation and Comparative Pharmacokinetics Study of UB-921 in Healthy Male Volunteers
Actual Study Start Date : March 5, 2018
Actual Primary Completion Date : October 8, 2018
Actual Study Completion Date : April 2, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Adverse event incidence [ Time Frame: 63 days ]
    from the baseline to the end of study visit



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03013881


Locations
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Taiwan
Prime site
Taipei, Taiwan
Sponsors and Collaborators
United BioPharma
Tri-Service General Hospital
Investigators
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Principal Investigator: Hsiang-Cheng Chen Tri-Service General Hospital

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Responsible Party: United BioPharma
ClinicalTrials.gov Identifier: NCT03013881     History of Changes
Other Study ID Numbers: UBP-A103-HER2
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by United BioPharma:
UB-921
anti-HER2 monoclonal antibody
breast neoplasm
breast cancer
Herceptin
Trastuzumab
HER2

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents