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

Phase 1

Completed

• Conditions: Autoimmunity; Immune System Diseases
• Interventions: Drug: Placebo; Drug: HIB210

• Registration Number: NCT05928585
• Lead Sponsor: HI-Bio, A Biogen Company

Brief 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.

Study Timeline

• Study First Submitted: 2023-06-12
• Study First Submitted QC: 2023-06-22
• Study First Posted: 2023-07-03
• Study Start: 2023-07-06
• Primary Completion: 2024-06-10
• Study Completion: 2024-06-10
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MAD Placebo	Placebo	Placebo will be administered for cohorts 1-4 in a multiple ascending dose format
MAD HIB210	HIB210	Increasing doses of HIB210 will be administered for cohorts 1-4 in a multiple ascending dose format

Primary Outcome Measures

Name	Time	Method
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 vital sign 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 adverse events	Baseline to End of Study (Up to Day 114)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

HI-Bio Investigational Site; 🇺🇸 Hialeah, Florida, United States