Safety, Tolerability and PK of a Single iv Infusion of 10, 40, and 80 µg/kg XG-102 Administered to Healthy Volunteers
NCT01570205 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2012-04-04
Summary
The objective of the study is to investigate safety, tolerability, and pharmacokinetics of XG-102 following iv infusion of single escalating dose of 10, 40, and 80 µg/kg XG-102 to healthy male volunteers
Conditions
Interventions
- DRUG
-
XG-102
single intravenous infusion
Sponsors & Collaborators
-
Xigen SA
lead INDUSTRY
Principal Investigators
-
Michael Seiberling, MD · Covance Clinical Research
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-07-31
- Primary Completion
- 2011-11-30
- Completion
- 2012-02-29
Countries
- Switzerland
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