A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UB-921 in Healthy Volunteers
NCT ID: NCT03013881
Last Updated: 2019-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2018-03-05
2019-04-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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UB-921 2 mg/kg (Main-study)
Intravenous infusion
UB-921
150 mg/vial
UB-921 6 mg/kg (Main-study)
Intravenous infusion
UB-921
150 mg/vial
UB-921 8 mg/kg (Main-study)
Intravenous infusion
UB-921
150 mg/vial
UB-921 6 mg/kg (Sub-study)
Intravenous infusion
UB-921
150 mg/vial
Herceptin 6 mg/kg (Sub-study)
Intravenous infusion
Herceptin
440 mg/vial
Interventions
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UB-921
150 mg/vial
Herceptin
440 mg/vial
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
20 Years
55 Years
MALE
Yes
Sponsors
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Tri-Service General Hospital
OTHER
United BioPharma
INDUSTRY
Responsible Party
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Principal Investigators
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Hsiang-Cheng Chen
Role: PRINCIPAL_INVESTIGATOR
Tri-Service General Hospital
Locations
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Prime site
Taipei, , Taiwan
Countries
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Other Identifiers
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UBP-A103-HER2
Identifier Type: -
Identifier Source: org_study_id
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