NCT05928585

A Study of Safety and Drug Levels of HIB210 in Healthy Volunteers

Phase 1 Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HIB210 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: HI-Bio, A Biogen Company · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to test safety of the investigational product in healthy volunteers. The main questions it aims to answer is when HIB210 is administered as multiple doses, is it: 1. Safe 2. Well tolerated 3. Does the body absorb and eliminate HIB210 as expected

Detailed description

Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.

Conditions

• Immune System Diseases
• Autoimmunity

Interventions

Type	Name	Description
DRUG	HIB210	Experimental monoclonal antibody
DRUG	Placebo	Placebo

Timeline

• Start date: 2023-07-06
• Primary completion: 2024-06-10
• Completion: 2024-06-10
• First posted: 2023-07-03
• Last updated: 2025-02-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study