Herpes Simplex Virus InfectionPhase 1NCT02346760
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of UB-621 in Healthy Volunteers
A Phase 1 study testing UB-621 in people with Herpes Simplex Virus Infection, run by United BioPharma at 1 site in Taiwan.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of a single subcutaneous dose of UB-621 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Herpes Simplex Virus Infection
- What is being tested?
- UB-621
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2015to Jan 2017
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- With age between 20 and 55 years.
- With no clinically relevant abnormalities in vital signs, and clinical laboratory tests at screening visit judged by investigator.
- Body weight: <85 kg.
- Subject has signed the written informed consent form.
Who cannot join
- With significant active infection (acute or chronic) within 28 days prior to the screening visit.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases, or clinical findings within 3 months prior to the screening visit.
- Positive serology for HIV antibody, HCV antibody or HBV surface antigen.
- Female subjects who are breastfeeding, pregnant, and planning to become pregnant during the study period.
- The clinical investigator considers that the subject is not in the condition to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Subcutaneous Dose of UB-621 in Healthy Volunteers
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of a single subcutaneous dose of UB-621 in healthy volunteers.
Read the detailed description
This is a phase I, open-label, single dose, dose escalation study in healthy volunteers. Eligible volunteers will be sequentially enrolled into four escalating-dose cohorts at a study site. After administration of a single subcutaneous dose of UB-621, subjects will be followed for 70 or 112 days and monitored for safety, tolerability, and pharmacokinetics parameters.
- Conditions
- Herpes Simplex Virus Infection
- Being tested
- UB-621
- Medical subject headings
- Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UB-621Drug
100 mg/ml, subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| UB-621 | Experimental | Intervention drug: UB-621 Receives: Drug: UB-621 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: Up to 70 or 112 days
Secondary outcomes (1)
Peak concentration of UB-621
Measured: Up to 70 or 112 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startDec 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes Simplex Virus InfectionStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- United BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Taipei Veterans General Hospital, Taiwan
- Responsible party
- Sponsor
- Investigators
- Wing Wai Wong, MD, Principal investigator, Taipei Veterans General Hoapital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02346760
- Sponsor's protocol ID
- A101-HSV
- Status last verified
- Apr 2019
- First submitted
- 14 Jan 2015
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Subcutaneous Dose of UB-621 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02346760
- Acronym / sponsor ID
- A101-HSV
- Conditions
- Herpes Simplex Virus Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- United BioPharmaIndustry (pharma, biotech, devices)
- Collaborators
- Taipei Veterans General Hospital, Taiwan
- Study start
- Dec 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 27 Jan 2015 (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 this study is to evaluate the safety, tolerability, and pharmacokinetics of a single subcutaneous dose of UB-621 in healthy volunteers.
Detailed description
This is a phase I, open-label, single dose, dose escalation study in healthy volunteers. Eligible volunteers will be sequentially enrolled into four escalating-dose cohorts at a study site. After administration of a single subcutaneous dose of UB-621, subjects will be followed for 70 or 112 days and monitored for safety, tolerability, and pharmacokinetics parameters.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UB-621 | Experimental | Drug: UB-621Intervention drug: UB-621 |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- With age between 20 and 55 years.
- With no clinically relevant abnormalities in vital signs, and clinical laboratory tests at screening visit judged by investigator.
- Body weight: <85 kg.
- Subject has signed the written informed consent form.
Key exclusion criteria (5 listed)
- With significant active infection (acute or chronic) within 28 days prior to the screening visit.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases, or clinical findings within 3 months prior to the screening visit.
- Positive serology for HIV antibody, HCV antibody or HBV surface antigen.
- Female subjects who are breastfeeding, pregnant, and planning to become pregnant during the study period.
- The clinical investigator considers that the subject is not in the condition to participate in this study.
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-621100 mg/ml, subcutaneous injection | Drug | UB-621 |
Primary outcome
Number of participants with adverse events
Time frame: Up to 70 or 112 days
1 secondary outcome
Peak concentration of UB-621
Time frame: Up to 70 or 112 days
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 18 Apr 2019.
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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.
Wing Wai Wong, MD principal investigator
Taipei Veterans General Hoapital
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-621 in people with Herpes Simplex Virus Infection, 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 5 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 18 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?
Number of participants with adverse events (time frame: Up to 70 or 112 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 18 Apr 2019.