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

Coronavirus Disease 2019 (COVID-19) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04516564
• Other study ID #: AK119-101
• Status: Completed
• Phase: Phase 1
• Start date: September 29, 2020
• Est. completion date: June 18, 2021

Study information

• Verified date: October 2021
• Source: Akeso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 18, 2021
• Est. primary completion date: March 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Disease 2019 (COVID-19)
• COVID-19

Intervention

Drug:
• AK119
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

Locations

Country	Name	City	State
New Zealand	Christchurch Clinical Studies Trust	Christchurch

Sponsors (1)

Lead Sponsor	Collaborator
Akesobio Australia Pty Ltd

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent AEs		From signing of informed consent till end of study (approximately 64 days postdose)
Secondary	Maximum serum concentration (Cmax) of AK119		From baseline till end of study (approximately 64 days postdose)
Secondary	Area under the concentration-time curve (AUC) of serum concentration of AK119		From baseline till end of study (approximately 64 days postdose)
Secondary	Percentage of subjects who develop detectable anti-drug antibodies (ADAs)		From baseline till end of study (approximately 64 days postdose)