A First-In-Human Study With a Single Dose UCB7665 in Healthy Volunteers
NCT02220153 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41
Last updated 2015-10-05
Summary
This study is designed to evaluate the safety and tolerability of single ascending doses of UCB7665 administered by intravenous or subcutaneous infusion in healthy subjects.
Conditions
- Healthy
Interventions
- BIOLOGICAL
-
UCB7665 Intravenous 1
* Active substance: UCB7665 * Pharmaceutical form: solution * Concentration: 140 mg/mL * Route of Administration: intravenous infusion
- BIOLOGICAL
-
UCB7665 Intravenous 2
* Active substance: UCB7665 * Pharmaceutical form: solution * Concentration: 140 mg/mL * Route of Administration: intravenous infusion
- BIOLOGICAL
-
UCB7665 Intravenous 3
* Active substance: UCB7665 * Pharmaceutical form: solution * Concentration: 140 mg/mL * Route of Administration: intravenous infusion
- BIOLOGICAL
-
UCB7665 Intravenous 4
* Active substance: UCB7665 * Pharmaceutical form: solution * Concentration: 140 mg/mL * Route of Administration: intravenous infusion
- BIOLOGICAL
-
UCB7665 Intravenous 5
* Active substance: UCB7665 * Pharmaceutical form: solution * Concentration: 140 mg/mL * Route of Administration: intravenous infusion
- BIOLOGICAL
-
UCB7665 Subcutaneous 1
* Active substance: UCB7665 * Pharmaceutical form: solution * Concentration: 140 mg/mL * Route of Administration: subcutaneous infusion
- BIOLOGICAL
-
UCB7665 Subcutaneous 2
* Active substance: UCB7665 * Pharmaceutical form: solution * Concentration: 140 mg/mL * Route of Administration: subcutaneous infusion
- BIOLOGICAL
-
Intravenous Placebo
* Active substance: Placebo * Pharmaceutical form: solution * Concentration: 0.9 % saline * Route of Administration: intravenous infusion
- BIOLOGICAL
-
Subcutaneous Placebo
* Active substance: Placebo * Pharmaceutical form: solution * Concentration: 0.9 % saline * Route of Administration: subcutaneous infusion
Sponsors & Collaborators
-
Parexel
collaborator INDUSTRY -
UCB Celltech
lead INDUSTRY
Principal Investigators
-
UCB Clinical Trial Call Center · UCB Pharma
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-07-31
- Primary Completion
- 2015-09-30
- Completion
- 2015-09-30
Countries
- United Kingdom
Study Locations
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