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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:
Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAD HIB210 | Experimental | Increasing doses of HIB210 will be administered for cohorts 1-4 in a multiple ascending dose format |
|
| MAD Placebo | Placebo Comparator | Placebo will be administered for cohorts 1-4 in a multiple ascending dose format |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIB210 | Drug | Experimental monoclonal antibody |
| |
| Placebo |
| Measure | Description | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| PK Parameters: Cmax | Maximum Serum Concentration (Cmax) | Baseline to Day 29 |
| PK Parameters: tmax | Time to Maximum Serum Concentration (tmax) |
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Key Eligibility Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | HI-Bio, A Biogen Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HI-Bio Investigational Site | Hialeah | Florida | 33014 | United States |
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D001327 | Autoimmune Diseases |
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| Drug |
Placebo |
|
| 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) |