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

United BioPharma

Status and phase: Completed; Phase 1

Conditions: Breast Neoplasm

Treatments: Biological: Herceptin; Biological: UB-921

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03013881

UBP-A103-HER2

Details and patient eligibility

About

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single-dose of UB-921 in healthy male volunteers.

Full 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).

Enrollment: 18 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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18 participants in 5 patient groups

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

Experimental group

Description:

Intravenous infusion

Treatment:

Biological: UB-921

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

Experimental group

Description:

Intravenous infusion

Treatment:

Biological: UB-921

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

Experimental group

Description:

Intravenous infusion

Treatment:

Biological: UB-921

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

Experimental group

Description:

Intravenous infusion

Treatment:

Biological: UB-921

Herceptin 6 mg/kg (Sub-study)

Active Comparator group

Description:

Intravenous infusion

Treatment:

Biological: Herceptin