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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04516564
Recruitment Status : Completed
First Posted : August 18, 2020
Last Update Posted : October 18, 2021
Sponsor:
Information provided by (Responsible Party):
Akeso ( Akesobio Australia Pty Ltd )

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

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Study Type : Interventional  (Clinical Trial)
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 : September 29, 2020
Actual Primary Completion Date : March 4, 2021
Actual Study Completion Date : June 18, 2021

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




Primary Outcome Measures :
  1. Incidence of treatment-emergent AEs [ Time Frame: From signing of informed consent till end of study (approximately 64 days postdose) ]

Secondary Outcome Measures :
  1. Maximum serum concentration (Cmax) of AK119 [ Time Frame: From baseline till end of study (approximately 64 days postdose) ]
  2. Area under the concentration-time curve (AUC) of serum concentration of AK119 [ Time Frame: From baseline till end of study (approximately 64 days postdose) ]
  3. Percentage of subjects who develop detectable anti-drug antibodies (ADAs) [ Time Frame: From baseline till end of study (approximately 64 days postdose) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04516564


Locations
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New Zealand
Christchurch Clinical Studies Trust
Christchurch, New Zealand
Sponsors and Collaborators
Akesobio Australia Pty Ltd
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Akesobio Australia Pty Ltd
ClinicalTrials.gov Identifier: NCT04516564    
Other Study ID Numbers: AK119-101
First Posted: August 18, 2020    Key Record Dates
Last Update Posted: October 18, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Akeso ( Akesobio Australia Pty Ltd ):
Anti-CD73
immunotherapy
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases