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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03013881

Enrollment

Registered

2017-01-09

Start date

2018-03-05

Completion date

2019-04-02

Last updated

2019-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasm

Keywords

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

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.

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).

Interventions

BIOLOGICALUB-921

150 mg/vial

BIOLOGICALHerceptin

440 mg/vial

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 55 Years

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

* 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)

Design outcomes

Primary

Measure	Time frame	Description
Adverse event incidence	63 days	from the baseline to the end of study visit

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026