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

• Sponsor: Akesobio Australia Pty Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04516564
• Collaborator: (none)
• Enrollment: 29
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.6
• Patients Per Site Per Month: 3.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronavirus Disease 2019 (COVID-19)	Drug: AK119; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Sep 29, 2020
• Actual Primary Completion Date: Mar 4, 2021
• Actual Study Completion Date: Jun 18, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AK119 Single dose of AK119 is administered via intravenous infusion to healthy subjects.	Drug: AK119; Single dose of AK119 is administered via intravenous infusion to healthy subjects
Experimental: Placebo Single dose of placebo is administered via intravenous infusion to healthy subjects.	Drug: Placebo; Single dose of placebo is administered via intravenous infusion to healthy subjects

Outcome Measures

Primary Outcome Measures

1. Incidence of treatment-emergent AEs [From signing of informed consent till end of study (approximately 64 days postdose)]

Secondary Outcome Measures

1. Maximum serum concentration (Cmax) of AK119 [From baseline till end of study (approximately 64 days postdose)]

2. Area under the concentration-time curve (AUC) of serum concentration of AK119 [From baseline till end of study (approximately 64 days postdose)]

3. Percentage of subjects who develop detectable anti-drug antibodies (ADAs) [From baseline till end of study (approximately 64 days postdose)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Christchurch Clinical Studies Trust	Christchurch		New Zealand

Sponsors and Collaborators

• Akesobio Australia Pty Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Akesobio Australia Pty Ltd
• ClinicalTrials.gov Identifier: NCT04516564
• Other Study ID Numbers: AK119-101
• First Posted: Aug 18, 2020
• Last Update Posted: Oct 18, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Akesobio Australia Pty Ltd: Anti-CD73; immunotherapy
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Oct 18, 2021