Breast NeoplasmPhase 1NCT03013881
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UB-921 in Healthy Volunteers
A Phase 1 study testing UB-921 and Herceptin in people with Breast Neoplasm, run by United BioPharma at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- UB-921 and Herceptin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Mar 2018to 2 Apr 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Breast Neoplasm
- Being tested
- UB-921, Herceptin
- Keywords
- UB-921, anti-HER2 monoclonal antibody, breast neoplasm, breast cancer, Herceptin, Trastuzumab, HER2
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UB-921Biological
150 mg/vial
HerceptinBiological
440 mg/vial
| Study group | Role | What they receive |
|---|---|---|
| UB-921 2 mg/kg (Main-study) | Experimental | Intravenous infusion Receives: Biological: UB-921 |
| UB-921 6 mg/kg (Main-study) | Experimental | Intravenous infusion Receives: Biological: UB-921 |
| UB-921 8 mg/kg (Main-study) | Experimental | Intravenous infusion Receives: Biological: UB-921 |
| UB-921 6 mg/kg (Sub-study) | Experimental | Intravenous infusion Receives: Biological: UB-921 |
| Herceptin 6 mg/kg (Sub-study) | Active comparator | Intravenous infusion Receives: Biological: Herceptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event incidence
from the baseline to the end of study visit
Measured: 63 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study start5 Mar 2018
- Primary completion8 Oct 2018
- Study completion2 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- United BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tri-Service General Hospital (TSGH)
- Responsible party
- Sponsor
- Investigators
- Hsiang-Cheng Chen, Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013881
- Sponsor's protocol ID
- UBP-A103-HER2
- Status last verified
- Apr 2019
- First submitted
- 2 Jan 2017
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Two-part, Dose-escalation and Comparative Pharmacokinetics Study of UB-921 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03013881
- Acronym / sponsor ID
- UBP-A103-HER2
- Conditions
- Breast Neoplasm
- Keywords
- UB-921, anti-HER2 monoclonal antibody, breast neoplasm, breast cancer, Herceptin, Trastuzumab, HER2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- United BioPharmaIndustry (pharma, biotech, devices)
- Collaborators
- Tri-Service General Hospital (TSGH)
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 8 Oct 2018 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 9 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| UB-921 2 mg/kg (Main-study) | Experimental | Biological: UB-921Intravenous infusion |
| UB-921 6 mg/kg (Main-study) | Experimental | Biological: UB-921Intravenous infusion |
| UB-921 8 mg/kg (Main-study) | Experimental | Biological: UB-921Intravenous infusion |
| UB-921 6 mg/kg (Sub-study) | Experimental | Biological: UB-921Intravenous infusion |
| Herceptin 6 mg/kg (Sub-study) | Active comparator | Biological: HerceptinIntravenous infusion |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UB-921150 mg/vial | Biological | UB-921 2 mg/kg (Main-study), UB-921 6 mg/kg (Main-study), UB-921 6 mg/kg (Sub-study), UB-921 8 mg/kg (Main-study) |
| Herceptin440 mg/vial | Biological | Herceptin 6 mg/kg (Sub-study) |
Primary outcome
Adverse event incidence
Time frame: 63 days
from the baseline to the end of study visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsiang-Cheng Chen principal investigator
Tri-Service General Hospital (TSGH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UB-921 and Herceptin in people with Breast Neoplasm, run by United BioPharma at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event incidence (time frame: 63 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2019.