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

Last updated: February 5, 2025
Sponsor: HI-Bio, A Biogen Company
Overall Status: Completed

Phase

1

Condition

Connective Tissue Diseases

Collagen Vascular Diseases

Autoimmune Disease

Treatment

HIB210

Placebo

Clinical Study ID

NCT05928585
HIB-210-101
  • Ages 19-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Key Eligibility Criteria:

  • Healthy male and females between 19 to 65 years of age

  • Normal or not significantly abnormal laboratory tests and EKG findings during Screening

  • No significant medical conditions that might affect ability to participate in the study or present a safety risk

  • No evidence of significant or recurrent infection or recent infection

  • No history of cancer other than certain skin cancers and limited cancer of the cervix of the womb

  • Willingness to comply with birth control requirements of the study (for both men and women)

  • No recent major surgery or trauma or planned surgery during the study or within 1 month after the study

  • Body mass index (BMI) between 18 and 32 kg/m2

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: HIB210
Phase: 1
Study Start date:
July 06, 2023
Estimated Completion Date:
June 10, 2024

Study Description

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

Connect with a study center

  • HI-Bio Investigational Site

    Hialeah, Florida 33014
    United States

    Site Not Available

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