NCT04896541

Brief Summary

AZD7442 mAbs are being evaluated for administration to prevent or treat COVID-19. This Phase I study will gather important information on the safety and tolerability of AZD7442.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_1 covid19

Timeline
Completed

Started Mar 2021

Typical duration for phase_1 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

March 16, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 21, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2022

Completed
Last Updated

June 27, 2022

Status Verified

June 1, 2022

Enrollment Period

1.2 years

First QC Date

February 26, 2021

Last Update Submit

June 24, 2022

Conditions

COVID-19

Outcome Measures

Primary Outcomes (9)

  • Adverse event and serious adverse event

    To evaluate the safety and tolerability of AZD7442 administered IV or IM\_Adverse event and serious adverse event

    Up to Day361

  • Pharmacokinetics - Serum Concentration

    To evaluate the single-dose PK of AZD7442.

    Up to Day361

  • Pharmacokinetics - Maximum Serum Concentration

    To evaluate the single-dose PK of AZD7442.

    Up to Day361

  • Pharmacokinetics - Time to Maximum Serum Concentration

    To evaluate the single-dose PK of AZD7442.

    Up to Day361

  • Pharmacokinetics - Area under the plasma concentration-time curve to the last measurable time point

    To evaluate the single-dose PK of AZD7442.

    Up to Day361

  • Pharmacokinetics - Area under the plasma concentration-time curve extrapolated to infinity

    To evaluate the single-dose PK of AZD7442.

    Up to Day361

  • Pharmacokinetics - extravascular systemic clearance

    To evaluate the single-dose PK of AZD7442.

    Up to 361

  • Pharmacokinetics -bioavailability

    To evaluate the single-dose PK of AZD7442.

    Up to Day361

  • Pharmacokinetics -extravascular terminal phase volume of distribution

    To evaluate the single-dose PK of AZD7442.

    Up to Day361

Secondary Outcomes (3)

  • The serum neutralizing responses against SARS-CoV-2 using Geometric mean fold rise from baseline

    Up to Day361

  • ADA responses to the AZD7442 in serum.

    Up to Day361

  • The serum neutralizing responses against SARS-CoV-2 using Geometric mean titre from baseline

    Up to Day361

Study Arms (2)

AZD7442

EXPERIMENTAL

Single dose (IM injections or IV administration) of AZD7442 or saline placebo on Day 1.

Biological: AZD7442 300 mg IM(male)Biological: AZD7442 600 mg IM (male)Biological: AZD7442 300 mg IV (male and female)Biological: AZD7442 1000 mg IV (male)

placebo

EXPERIMENTAL

Single dose (× 2 separate IM injections or IV administration) of AZD7442 or saline placebo on Day 1.

Biological: AZD7442 300 mg IM(male)Biological: AZD7442 600 mg IM (male)Biological: AZD7442 300 mg IV (male and female)Biological: AZD7442 1000 mg IV (male)

Interventions

AZD7442 300 mg IM(male)BIOLOGICAL

Single dose of 300 mg of AZD7442 or saline placebo on Day 1.

AZD7442placebo
AZD7442 600 mg IM (male)BIOLOGICAL

Single dose of 600 mg of AZD7442 or saline placebo on Day 1.

AZD7442placebo
AZD7442 300 mg IV (male and female)BIOLOGICAL

Single dose of 300 mg of AZD7442 or saline placebo on Day 1.

AZD7442placebo
AZD7442 1000 mg IV (male)BIOLOGICAL

Single dose 1000 mg of AZD7442 or saline placebo on Day 1.

AZD7442placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants must be Japanese men and women and 18 to 55 years of age inclusive, at the time of signing the informed consent.
  • Negative results from both SARS-CoV-2 qRT-PCR and serology tests
  • Healthy by medical history, physical examination, and safety laboratory tests, according to the judgement of the investigators

You may not qualify if:

  • Fever above 37.5°C by the time when the participant is randomised; a participant excluded for transient acute illness may be dosed if the illness resolves by the time of randomisation.
  • History of infection with SARS or MERS
  • Any drug therapy within 7 days prior to Day 1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Fukuoka, 812-0025, Japan

Location

Related Publications (2)

  • Okada H, Ishikawa K, Itoh Y, Noda Y, Eto T, Pilla Reddy V, Chen CC, Gibbs M, Johnsson E. Safety, tolerability, and pharmacokinetics of half-life extended SARS-CoV-2-neutralizing monoclonal antibodies AZD7442 (tixagevimab/cilgavimab) in healthy Japanese adults. J Infect Chemother. 2023 Nov;29(11):1061-1067. doi: 10.1016/j.jiac.2023.07.014. Epub 2023 Jul 29.

    PMID: 37524201DERIVED

  • Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

    PMID: 34473343DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

cilgavimab and tixagevimab drug combination

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2021

First Posted

May 21, 2021

Study Start

March 16, 2021

Primary Completion

June 14, 2022

Study Completion

June 14, 2022

Last Updated

June 27, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will share

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indeed that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
More information

Locations

JP(1)