MedTrace Logo

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

NCT03859219 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2021-09-16

No results posted yet for this study

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

DRUG

Rozanolixizumab

* Pharmaceutical form: solution for injection * Route of administration: subcutaneous infusion

DRUG

Placebo

* Pharmaceutical form: solution for injection * Route of administration: subcutaneous infusion

Sponsors & Collaborators

  • UCB Biopharma S.P.R.L.

    lead INDUSTRY

Principal Investigators

  • UCB Cares · 001 844 599 2273 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-18
Primary Completion
2020-04-28
Completion
2020-04-28

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03859219 on ClinicalTrials.gov