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

Primary Purpose

Coronavirus Disease 2019 (COVID-19)

Status

Completed

Phase

Phase 1

Locations

New Zealand

Study Type

Interventional

Intervention

AK119

Placebo

About this trial

This is an interventional other trial for Coronavirus Disease 2019 (COVID-19) focused on measuring Anti-CD73, immunotherapy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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 laboratory"s 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 subject"s 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.

Sites / Locations

Christchurch Clinical Studies Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

AK119

Placebo

Arm Description

Single dose of AK119 is administered via intravenous infusion to healthy subjects.

Single dose of placebo is administered via intravenous infusion to healthy subjects.

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent AEs

Secondary Outcome Measures

Maximum serum concentration (Cmax) of AK119

Area under the concentration-time curve (AUC) of serum concentration of AK119

Percentage of subjects who develop detectable anti-drug antibodies (ADAs)

Full Information

NCT ID

NCT04516564

First Posted

August 13, 2020

Last Updated

October 15, 2021

Sponsor

Akesobio Australia Pty Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04516564

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

September 29, 2020 (Actual)

Primary Completion Date

March 4, 2021 (Actual)

Study Completion Date

June 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Akesobio Australia Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronavirus Disease 2019 (COVID-19)

Keywords

Anti-CD73, immunotherapy

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AK119

Arm Type

Experimental

Arm Description

Single dose of AK119 is administered via intravenous infusion to healthy subjects.

Arm Title

Placebo

Arm Type

Experimental

Arm Description

Single dose of placebo is administered via intravenous infusion to healthy subjects.

Intervention Type

Drug

Intervention Name(s)

AK119

Intervention Description

Single dose of AK119 is administered via intravenous infusion to healthy subjects

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Single dose of placebo is administered via intravenous infusion to healthy subjects

Primary Outcome Measure Information:

Title

Incidence of treatment-emergent AEs

Time Frame

From signing of informed consent till end of study (approximately 64 days postdose)

Secondary Outcome Measure Information:

Title

Maximum serum concentration (Cmax) of AK119

Time Frame

From baseline till end of study (approximately 64 days postdose)

Title

Area under the concentration-time curve (AUC) of serum concentration of AK119

Time Frame

From baseline till end of study (approximately 64 days postdose)

Title

Percentage of subjects who develop detectable anti-drug antibodies (ADAs)

Time Frame

From baseline till end of study (approximately 64 days postdose)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 laboratory"s 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 subject"s 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.

Facility Information:

Facility Name

Christchurch Clinical Studies Trust

City

Christchurch

Country

New Zealand

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34473343

Citation

Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

Results Reference

derived

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

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