Study to Evaluate Safety, Tolerability, and Pharmacokinetics of UB-621 in Healthy Volunteers

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: United BioPharma
• Collaborator: Taipei Veterans General Hospital, Taiwan

Criteria

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.