Autoimmunity, Immune System Diseases
Conditions
Keywords
C5aR1, C5a receptor, C5aR1 inhibition, CD88
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.
Interventions
DRUGHIB210
Experimental monoclonal antibody
DRUGPlacebo
Placebo
Sponsors
HI-Bio, A Biogen Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with vital sign 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) |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK Parameters: tmax | Baseline to Day 29 | Time to Maximum Serum Concentration (tmax) |
| PK Parameters: AUC | Baseline to Day 29 | Area under the serum concentration-time curve |
| Anti-drug Antibodies (ADA) | Baseline to End of Study (Up to Day 114) | Baseline prevalence and post-dose incidence of ADA |
| PK Parameters: Cmax | Baseline to Day 29 | Maximum Serum Concentration (Cmax) |
Countries
United States
Outcome results
None listed