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CompletedNCT03013881Updated Apr 3, 2019

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

A Phase 1 interventional study of UB-921 and Herceptin in Breast Neoplasm, sponsored by United BioPharma. Completed at 1 site in Taiwan. Open to male participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-03.

Sponsored by United BioPharma · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Non-randomized
Ages
20 Years to 55 Years
Sex
Male
01

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.

Read the 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).

02

Conditions studied

  • Breast Neoplasm

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Keywords

  • UB-921
  • anti-HER2 monoclonal antibody
  • breast neoplasm
  • breast cancer
  • Herceptin
  • Trastuzumab
  • HER2
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 18 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

United BioPharma is the lead sponsor of 15 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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)
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    UB-921 2 mg/kg (Main-study)

    Intravenous infusion

    Biological: UB-921

  • Experimental
    UB-921 6 mg/kg (Main-study)

    Intravenous infusion

    Biological: UB-921

  • Experimental
    UB-921 8 mg/kg (Main-study)

    Intravenous infusion

    Biological: UB-921

  • Experimental
    UB-921 6 mg/kg (Sub-study)

    Intravenous infusion

    Biological: UB-921

  • Active comparator
    Herceptin 6 mg/kg (Sub-study)

    Intravenous infusion

    Biological: Herceptin

Interventions

  • BiologicalUB-921

    150 mg/vial

  • BiologicalHerceptin

    440 mg/vial

06

What researchers measure

Primary outcomes

  1. Adverse event incidence

    from the baseline to the end of study visit

    Time frame: 63 days

07

Study locations

1 site
  • Prime site
    Taipei, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03013881
Lead sponsor
United BioPharma
Collaborators
Tri-Service General Hospital
Responsible party
Sponsor
First posted
Jan 9, 2017
Start date
Mar 5, 2018
Primary completion
Oct 8, 2018
Completion
Apr 2, 2019
Last update
Apr 3, 2019

Study contacts

Hsiang-Cheng Chen
principal investigator · Tri-Service General Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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