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

Akesobio Australia Pty Ltd1 site in 1 country29 target enrollmentSeptember 28, 2020

ConditionsCoronavirus Disease 2019 (COVID-19)

InterventionsAK119 Placebo

DrugsAK119 Placebo

Overview

Phase: Phase 1
Intervention: AK119
Conditions: Coronavirus Disease 2019 (COVID-19)
Sponsor: Akesobio Australia Pty Ltd
Enrollment: 29
Locations: 1
Primary Endpoint: Incidence of treatment-emergent AEs
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 28, 2020

End Date

June 21, 2021

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Akesobio Australia Pty Ltd

Responsible Party

Sponsor

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.

Arms & Interventions

AK119

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

Intervention: AK119

Placebo

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

Intervention: Placebo

Outcomes

Primary Outcomes

Incidence of treatment-emergent AEs

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

Secondary Outcomes

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))