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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04516564

Enrollment

Registered

2020-08-18

Start date

2020-09-28

Completion date

2021-06-21

Last updated

2025-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus Disease 2019 (COVID-19)

Keywords

Anti-CD73, immunotherapy

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.

Interventions

DRUGAK119

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

OTHER

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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 laboratorys reference normal ranges.

Exclusion criteria

Subjects who meet ANY of the following

Design outcomes

Primary

Measure	Time frame
Incidence of treatment-emergent AEs	From signing of informed consent till end of study (approximately 64 days postdose)

Secondary

Measure	Time frame
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)

Countries

New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026