NCT02220153

A First-In-Human Study With a Single Dose UCB7665 in Healthy Volunteers

A Subject-Blind, Investigator-blind, Randomized, Placebo-controlled, First-in-human Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous and Subcutaneous Doses of UCB7665 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: UCB Celltech · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2014-08-19
• Last updated: 2015-10-05

Locations

1 site across 1 country: United Kingdom