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

NCT03013881 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2019-04-03

No results posted yet for this study

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.

Conditions

  • Breast Neoplasm

Interventions

BIOLOGICAL

UB-921

150 mg/vial

BIOLOGICAL

Herceptin

440 mg/vial

Sponsors & Collaborators

  • Tri-Service General Hospital

    collaborator OTHER

  • United BioPharma

    lead INDUSTRY

Principal Investigators

  • Hsiang-Cheng Chen · Tri-Service General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-05
Primary Completion
2018-10-08
Completion
2019-04-02

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03013881 on ClinicalTrials.gov