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COMPLETED
NCT05418101
PHASE1

A Study to Evaluate the Safety, PK and PD of VIS171 in Participants (Healthy and With Autoimmune Disease)

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

Summary

This is a phase 1 study to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of VIS171 in healthy participants and in participants with autoimmune disease(s).

Official title: A Phase 1, First-in-human, 2-part Study (Part 1 is a Single Ascending Dose in Healthy Participants; Part 2 is a Multiple Ascending Dose Study in Participants With Autoimmune Disease) to Evaluate the Safety, PD and PK of VIS171

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

61

Start Date

2022-04-28

Completion Date

2024-03-13

Last Updated

2026-04-15

Healthy Volunteers

Yes

Interventions

DRUG

VIS171

Participants will receive VIS171 via SC route of administration.

DRUG

Placebo

Participants will receive Placebo via SC route of administration

Locations (10)

UMHAT

Plovdiv, Bulgaria

Ambulatory for Specialized Medical Help - skin and venereal diseases

Sofia, Bulgaria

Comac Medical Ltd

Sofia, Bulgaria

MBAL Sveta Sofia

Sofia, Bulgaria

Diagnostic and Consultative Center Convex EOOD

Sofia, Bulgaria

Universitaetsklinikum Bonn AöR

Bonn, Germany

Universitätsmedizin der Johannes-Gutenberg-Universität Mainz

Rheinland-Pfalz, Germany

Clinical republican Hospital

Chisinau, Moldova

Radboud University Medical Center

Gelderland, Netherlands

New Zealand Clinical Research

Christchurch, New Zealand