Single Ascending Dose Study of ANX105

Study Overview
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Brief Summary
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This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of ANX105 administered intravenously (IV) to healthy participants.

Detailed Description
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This is a single-center, first-in-human, randomized, double-blind, placebo-controlled single ascending dose study in healthy adult participants. This study consists of an approximately 6 to 10 weeks Screening Period and a 7-week treatment period composed of a 6-day confinement period (Day -1 to Day 5), and outpatient visits up to Day 43 (Week 7).

Official Title
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A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous ANX105 in Normal Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Biological: ANX105
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests. Have been fully vaccinated with SARS-CoV-2 vaccination according to local guidelines within 14 days prior to Day -1. Documented history of vaccinations within 5 years or willing to undergo vaccinations prior to screening visit against encapsulated bacterial pathogens. Key Exclusion Criteria: Clinically significant infection within 30 days prior to Day -1 that required medical intervention. Significant allergies to humanized monoclonal antibodies. Use of immunosuppressants including high-dose systemic corticosteroids within 30 days prior to Day -1. Antinuclear antibodies (ANA) titer ≥1:160 (for either of the 2 ANA results a minimum of 2 weeks apart) at Screening. Have poor venous access limiting phlebotomy. Donation or loss of > 500 milliliter whole blood within 30 days prior to Day 1 or donation of plasma within 14 days prior to Day -1. Hospitalization during the 4 weeks prior to Screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Sequential Assignment
Interventional Model Description: Placebo-controlled single ascending dose study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ANX105<br> | Biological: ANX105<br>* Participants will receive single-ascending doses of ANX105 administered by IV infusion.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Participants will receive matching placebo administered by IV infusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experienced Treatment-Emergent Adverse Events |  | Up to Week 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Serum Total Hemolytic Complement (CH50) | Blood samples will be obtained to determine the amount of CH50. | Up to Week 7 | 
| Change from Baseline in Amount of Unbound Complement 1q (C1q) in Serum | Blood samples will be obtained to determine the amount of C1q. | Baseline, Week 7 | 
| Amount of C1q in Cerebrospinal fluid (CSF) | CSF samples will be obtained to determine the amount of C1q. | Up to Week 7 | 
| Serum Concentrations of ANX105 | Blood samples will be obtained to determine serum concentrations of ANX105. | Up to Week 7 | 
| Maximum Observed Serum Concentration (Cmax) of ANX105 | Blood samples will be obtained to determine the Cmax of ANX105. | Up to Week 7 | 
| Area Under the ANX009 Serum Concentration-Time Curve (AUC) | Blood samples will be obtained to determine the AUC of ANX105. | Up to Week 7 | 
| CSF Concentrations of ANX105 | CSF samples will be obtained to determine CSF concentrations of ANX105. | Up to Week 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy