NCT03859219

A Study to Evaluate Safety and Tolerability of Single Ascending Doses of Rozanolixizumab Administered by Subcutaneous Infusion in Healthy Japanese, Chinese and Caucasian Study Participants

A Randomized, Participant-Blind, Investigator-Blind, Placebo-Controlled Study Comparing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Subcutaneous Doses of Rozanolixizumab in Japanese, Chinese and Caucasian Healthy-Volunteer Study Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: UCB Biopharma S.P.R.L. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of rozanolixizumab in japanese, chinese and caucasian healthy-volunteer study participants.

Conditions

• Healthy-volunteers

Interventions

Type	Name	Description
DRUG	Rozanolixizumab	* Pharmaceutical form: solution for injection * Route of administration: subcutaneous infusion
DRUG	Placebo	* Pharmaceutical form: solution for injection * Route of administration: subcutaneous infusion

Timeline

• Start date: 2019-03-18
• Primary completion: 2020-04-28
• Completion: 2020-04-28
• First posted: 2019-03-01
• Last updated: 2021-09-16

Locations

1 site across 1 country: United Kingdom