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NCT03013881 Clinical Trial

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

Breast Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03013881
Other study ID # UBP-A103-HER2
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date March 5, 2018
Est. completion date April 2, 2019

Study information
Verified date April 2019
Source United BioPharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date April 2, 2019
Est. primary completion date October 8, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 55 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• UB-921
150 mg/vial
• Herceptin
440 mg/vial

Locations
Country Name City State
Taiwan Prime site Taipei

Sponsors (2)
Lead Sponsor Collaborator
United BioPharma Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse event incidence from the baseline to the end of study visit 63 days
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