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

NCT ID: NCT04516564

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-28
• Study Completion Date: 2021-06-21

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.

Conditions

Coronavirus Disease 2019 (COVID-19)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

AK119

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

Group Type: EXPERIMENTAL

AK119

Intervention Type: DRUG

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

Placebo

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

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

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

Interventions

AK119

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Akesobio Australia Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Christchurch Clinical Studies Trust

Christchurch, , New Zealand

Countries

New Zealand

References

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.

Reference Type: DERIVED

PMID: 34473343 (View on PubMed)

Other Identifiers

AK119-101

Identifier Type: -

Identifier Source: org_study_id