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Completed

NCT Number: NCT03013881

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

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Key information

Conditions

Breast Neoplasm Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Prime site

Taipei, Taiwan

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

UB-921

Biological

150 mg/vial

herceptin

Biological

440 mg/vial

Primary outcomes

  1. Adverse event incidence

    Time frame: 63 days

    from the baseline to the end of study visit

Sponsors and collaborators

Lead sponsor

United BioPharma

Industry

Collaborators

  • Tri-Service General Hospital (TSGH)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jan 9, 2017
Registry last updated
Apr 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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