A Study of AK119 (Anti-CD73 Antibody), a Treatment for COVID-19, in Healthy Subjects

Study Overview
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Brief Summary
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This is a first-in-human (FIH), Phase 1, single-center, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, PK and immunogenicity of AK119, a humanized monoclonal antibody targeting the CD73. The study will consist of 4 cohorts of healthy subjects. Eight subjects will be enrolled per cohort, randomized in a 3:1 ratio to receive a single dose of either the active drug AK119 (N=6) or matching placebo (N=2). Approximately 32 subjects (24 receiving active drug and 8 receiving placebo) will participate in this study.

Official Title
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A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, First-In-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AK119 in Healthy Subjects

Conditions
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Coronavirus Disease 2019 (COVID-19)

Intervention / Treatment
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* Drug: AK119
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must meet ALL the following inclusion criteria (as applicable) to be eligible for participation in this study: Adults between 18 and 55 years of age, inclusive, at screening. Must have a calculated body mass index (BMI, weight [kg]/height [m2]) within 18.0 to 30.0 kg/m2 (inclusive) at screening, and a total body weight ≥50 kg for men or ≥45 kg for women at screening and Day -1 before randomization. Must, in the opinion of the Investigator, be in good general health based upon medical history, physical examination (including vital signs), and 12-lead ECG; and clinical laboratory tests (up to 1 repeat permitted) must fall within the clinical laboratorys reference normal ranges. Exclusion Criteria: Subjects who meet ANY of the following exclusion criteria will not be enrolled in this study Have a history of latent or active granulomatous infection, including histoplasmosis, candidiasis, or coccidioidomycosis prior to screening, or a history of any other infectious disease within 4 weeks prior to screening that, in the opinion of the Investigator, affects the subjects ability to participate in the study. Have a history of multiple drug allergies or a known allergy or hypersensitivity to any biologic therapy at screening that is important in the opinion of the Investigator. Have a known allergy or reaction to any component of the AK119 formulation. Have any known malignancy or have a history of malignancy within the previous 5 years. Have a 12-lead ECG demonstrating QTcF interval > 450 msec for male subjects and >470 msec for female subjects at screening and Day -1 from average of 3 ECGs obtained after 5 minutes of supine rest. Blood pressure (BP) >150 mmHg (systolic) or > 95 mmHg (diastolic) at screening and Day -1, following at least 5 minutes of supine rest. Have had a live vaccination within 12 weeks prior to the study dosing or intend to have a live vaccination during the course of the study or have participated in a vaccine clinical study within 12 weeks prior to the study dosing.

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: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AK119<br>Single dose of AK119 is administered via intravenous infusion to healthy subjects. | Drug: AK119<br>* Single dose of AK119 is administered via intravenous infusion to healthy subjects<br>|
| Experimental: Placebo<br>Single dose of placebo is administered via intravenous infusion to healthy subjects. | Drug: Placebo<br>* Single dose of placebo is administered via intravenous infusion to healthy subjects<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent AEs |  | From signing of informed consent till end of study (approximately 64 days postdose) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum serum concentration (Cmax) of AK119 |  | From baseline till end of study (approximately 64 days postdose) | 
| Area under the concentration-time curve (AUC) of serum concentration of AK119 |  | From baseline till end of study (approximately 64 days postdose) | 
| Percentage of subjects who develop detectable anti-drug antibodies (ADAs) |  | From baseline till end of study (approximately 64 days postdose) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anti-CD73, immunotherapy