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

NCT04516564 | Completed Phase 1

• 1 other identifier: AK119-101
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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)

Keywords

Anti-CD73; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent AEs

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

Secondary Outcomes (3)

• 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)

Study Arms (2)

AK119

EXPERIMENTAL

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

Drug: AK119

Placebo

EXPERIMENTAL

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

Drug: Placebo

Interventions

AK119 DRUG

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

AK119

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akesobio Australia Pty Ltd: lead

Study Sites (1)

Christchurch Clinical Studies Trust

Christchurch, New Zealand

Location

Related Publications (1)

• 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.

  PMID: 34473343 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 18, 2020
• Study Start: September 28, 2020
• Primary Completion: May 4, 2021
• Study Completion: June 21, 2021
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)