NCT02346760CompletedPhase 1
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
United BioPharma1 site in 1 country15 target enrollmentStarted: December 2015Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Number of participants with adverse events
Study Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
UB-621
Experimental
Intervention drug: UB-621
Intervention: UB-621 (Drug)
Outcomes
Primary Outcomes
Number of participants with adverse events
Time Frame: Up to 70 or 112 days
Secondary Outcomes
- Peak concentration of UB-621(Up to 70 or 112 days)
Investigators
Study Sites (1)
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