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

Study Overview
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Brief Summary
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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: Safe Well tolerated Does the body absorb and eliminate HIB210 as expected

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

Conditions
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Immune System Diseases, Autoimmunity

Intervention / Treatment
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* Drug: HIB210
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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C5aR1, C5a receptor, C5aR1 inhibition, CD88