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

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

Study Overview

• Status: Completed
• Conditions: Immune System Diseases; Autoimmunity
• Intervention / Treatment: Drug: Placebo; Drug: HIB210

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Hialeah, Florida, United States, 33014
      • HI-Bio Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MAD HIB210; Increasing doses of HIB210 will be administered for cohorts 1-4 in a multiple ascending dose format	Drug: HIB210; Experimental monoclonal antibody
Placebo Comparator: MAD Placebo; Placebo will be administered for cohorts 1-4 in a multiple ascending dose format	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events	Baseline to End of Study (Up to Day 114)
Number of participants with clinical laboratory abnormalities	Baseline to End of Study (Up to Day 114)
Number of participants with electrocardiogram (ECG) abnormalities	Baseline to End of Study (Up to Day 114)
Number of participants with physical examination abnormalities	Baseline to End of Study (Up to Day 114)
Number of participants with vital sign abnormalities	Baseline to End of Study (Up to Day 114)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK Parameters: Cmax	Maximum Serum Concentration (Cmax)	Baseline to Day 29
PK Parameters: tmax	Time to Maximum Serum Concentration (tmax)	Baseline to Day 29
PK Parameters: AUC	Area under the serum concentration-time curve	Baseline to Day 29
Anti-drug Antibodies (ADA)	Baseline prevalence and post-dose incidence of ADA	Baseline to End of Study (Up to Day 114)

Collaborators and Investigators

• Sponsor: HI-Bio, A Biogen Company
• Investigators: Study Director: Medical Director, HI-Bio, A Biogen Company

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2023
• Primary Completion (Actual): June 10, 2024
• Study Completion (Actual): June 10, 2024

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: June 22, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: C5aR1; C5a receptor; C5aR1 inhibition; CD88
• Additional Relevant MeSH Terms: Autoimmune Diseases; Immune System Diseases
• Other Study ID Numbers: HIB-210-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No