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OpenTrials
Completed

NCT Number: NCT05928585

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

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

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Key information

Conditions

Immune System Diseases Autoimmune Diseases Autoimmunity

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

HI-Bio Investigational Site

Hialeah, Florida, 33014, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HIB210

Drug

Experimental monoclonal antibody

Placebo

Drug

Placebo

Primary outcomes

  1. Number of participants with adverse events

    Time frame: Baseline to End of Study (Up to Day 114)

  2. Number of participants with clinical laboratory abnormalities

    Time frame: Baseline to End of Study (Up to Day 114)

  3. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Baseline to End of Study (Up to Day 114)

  4. Number of participants with physical examination abnormalities

    Time frame: Baseline to End of Study (Up to Day 114)

  5. Number of participants with vital sign abnormalities

    Time frame: Baseline to End of Study (Up to Day 114)

Secondary outcomes

  1. PK Parameters: Cmax

    Time frame: Baseline to Day 29

    Maximum Serum Concentration (Cmax)

  2. PK Parameters: tmax

    Time frame: Baseline to Day 29

    Time to Maximum Serum Concentration (tmax)

  3. PK Parameters: AUC

    Time frame: Baseline to Day 29

    Area under the serum concentration-time curve

  4. Anti-drug Antibodies (ADA)

    Time frame: Baseline to End of Study (Up to Day 114)

    Baseline prevalence and post-dose incidence of ADA

Sponsors and collaborators

Lead sponsor

HI-Bio, A Biogen Company

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 3, 2023
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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