- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03013881
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UB-921 in Healthy Volunteers
April 2, 2019 updated by: United BioPharma
Open-label, Two-part, Dose-escalation and Comparative Pharmacokinetics Study of UB-921 in Healthy Male Volunteers
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single-dose of UB-921 in healthy male volunteers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan
- Prime site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: UB-921 2 mg/kg (Main-study)
Intravenous infusion
|
150 mg/vial
|
EXPERIMENTAL: UB-921 6 mg/kg (Main-study)
Intravenous infusion
|
150 mg/vial
|
EXPERIMENTAL: UB-921 8 mg/kg (Main-study)
Intravenous infusion
|
150 mg/vial
|
EXPERIMENTAL: UB-921 6 mg/kg (Sub-study)
Intravenous infusion
|
150 mg/vial
|
ACTIVE_COMPARATOR: Herceptin 6 mg/kg (Sub-study)
Intravenous infusion
|
440 mg/vial
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse event incidence
Time Frame: 63 days
|
from the baseline to the end of study visit
|
63 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 5, 2018
Primary Completion (ACTUAL)
October 8, 2018
Study Completion (ACTUAL)
April 2, 2019
Study Registration Dates
First Submitted
January 2, 2017
First Submitted That Met QC Criteria
January 5, 2017
First Posted (ESTIMATE)
January 9, 2017
Study Record Updates
Last Update Posted (ACTUAL)
April 3, 2019
Last Update Submitted That Met QC Criteria
April 2, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UBP-A103-HER2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Neoplasm
-
Baylor College of MedicineThe Methodist Hospital Research Institute; Center for Cell and Gene Therapy...Not yet recruitingBreast Cancer | Neoplasm, Breast | Malignant Neoplasm of Breast | Breast Tumor | Mammary Cancer | Mammary Neoplasms, Human | Tumor, Breast | Mammary NeoplasmUnited States
-
National Cancer Institute (NCI)RecruitingAdvanced Malignant Solid Neoplasm | Refractory Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Triple-Negative Breast CarcinomaUnited States
-
Jonsson Comprehensive Cancer CenterU.S. Army Medical Research and Development Command; U.S. Army Medical Research...CompletedBreast Carcinoma | Malignant Breast Neoplasm | Benign Breast NeoplasmUnited States
-
National Cancer Institute (NCI)Active, not recruitingAdvanced Malignant Solid Neoplasm | Refractory Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | HER2-Positive Breast CarcinomaUnited States
-
Indiana UniversityIndiana University HealthCompletedBreast Cancer | Breast Neoplasms | Anxiety | Breast Carcinoma | Fear | Cancer of Breast | Malignant Tumor of Breast | Malignant Neoplasm of Breast | Mammary Cancer | Human Mammary Carcinoma | Mammary Neoplasm, Human | Mammary Carcinoma | Neoplasm Remission, Spontaneous | Spontaneous Neoplasm Regression | Regression,... and other conditionsUnited States
-
National Cancer Institute, ThailandCompleted
-
Umbria Bioengineering TechnologiesToscana Life Sciences Sviluppo s.r.l.; London South Bank University; ELAROS 24... and other collaboratorsRecruitingWomen's Health: Neoplasm of BreastItaly, Spain, Poland, Portugal, Switzerland
-
Istanbul Aydın UniversityActive, not recruiting
-
University of OviedoCompletedWomen's Health: Neoplasm of BreastSpain
-
National Cancer Institute, ThailandCompleted
Clinical Trials on UB-921
-
UBP Greater China (Shanghai) Co., LtdNot yet recruiting
-
UBP Greater China (Shanghai) Co., LtdNot yet recruitingChronic Spontaneous Urticaria
-
United BioPharmaTaipei Veterans General Hospital, TaiwanCompletedHerpes Simplex Virus InfectionTaiwan
-
Vaxxinity, Inc.Recruiting
-
Medical University of South CarolinaAugusta UniversityCompleted
-
Canopy Growth CorporationCentre hospitalier de l'Université de Montréal (CHUM); McGill University Health... and other collaboratorsTerminated
-
UBP Greater China (Shanghai) Co., LtdNot yet recruiting
-
United BioPharmaNational Taiwan University Hospital; Kaohsiung Medical University Chung-Ho... and other collaboratorsCompleted
-
NYU Langone HealthRecruiting
-
UBP Greater China (Shanghai) Co., LtdNot yet recruiting