NCT04828343

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Rozanolixizumab Administered Subcutaneously Via Manual Push Versus Syringe Driver to Healthy Participants

A Randomized, Participant-Blind, Investigator-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Rozanolixizumab Administered Subcutaneously Via Manual Push Versus Syringe Driver to Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single subcutaneous (SC) dose of rozanolixizumab administered to healthy participants by manual push (MP) versus (vs) syringe driver.

Conditions

• Healthy Study Participants

Interventions

Type	Name	Description
DRUG	rozanolixizumab	Study participants will receive a single dose rozanolixizumab subcutaneously administered by manual push or a syringe driver.
OTHER	Placebo	Study participants will receive a single dose placebo subcutaneously administered by manual push or a syringe driver.

Timeline

• Start date: 2021-04-22
• Primary completion: 2022-04-11
• Completion: 2022-04-11
• First posted: 2021-04-02
• Last updated: 2024-03-07
• Results posted: 2024-03-07

Locations

1 site across 1 country: United Kingdom