A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UB-921 in Healthy Volunteers
Phase 1
Completed
- Conditions
- Breast Neoplasm
- Registration Number
- NCT03013881
- Lead Sponsor
- United BioPharma
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 18
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
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method Adverse event incidence 63 days from the baseline to the end of study visit
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Prime site
🇨🇳Taipei, Taiwan
Prime site🇨🇳Taipei, Taiwan