Trials / Completed
CompletedNCT03013881
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
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- United BioPharma · Industry
- Sex
- Male
- Age
- 20 Years – 55 Years
- Healthy volunteers
- Accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | UB-921 | 150 mg/vial |
| BIOLOGICAL | Herceptin | 440 mg/vial |
Timeline
- Start date
- 2018-03-05
- Primary completion
- 2018-10-08
- Completion
- 2019-04-02
- First posted
- 2017-01-09
- Last updated
- 2019-04-03
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT03013881. Inclusion in this directory is not an endorsement.