Phase I Double-blind, Placebo-controlled Study of AZD7442

NCT ID: NCT04896541

Last Updated: 2022-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-16
• Study Completion Date: 2022-06-14

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.

Detailed Description

Severe acute respiratory coronavirus 2 is a novel coronavirus that appears to have first emerged in China in November 2019 causing cases of atypical pneumonia. Since then, the COVID-19 pandemic has caused major disruption to healthcare systems with significant socioeconomic impacts. As of 22 December 2020, the virus had spread to all corners of the globe, involving 218 countries/regions with over 78.00 million confirmed cases reported and more than 1.71 million associated deaths. As a response to the ongoing pandemic, AstraZeneca is developing mAbs to the SARS-CoV-2 spike protein. The SARS-CoV-2 spike protein contains the virus's receptor binding domain, which enables the virus to bind to receptors on human cells. By targeting this region of the virus's spike protein, antibodies can block the virus's attachment to human cells, and, therefore, are expected to block infection. AZD7442, a combination of 2 of these mAbs (AZD8895 and AZD1061), is being evaluated for administration to treat or prevent COVID-19. There are currently one ongoing Phase I study and two ongoing Phase III studies with AZD7442, in addition to this treatment study.

Randomization of approximately 40 Japanese participants is planned.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

AZD7442

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

Group Type: EXPERIMENTAL

AZD7442 300 mg IM(male)

Intervention Type: BIOLOGICAL

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

AZD7442 600 mg IM (male)

Intervention Type: BIOLOGICAL

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

AZD7442 300 mg IV (male and female)

Intervention Type: BIOLOGICAL

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

AZD7442 1000 mg IV (male)

Intervention Type: BIOLOGICAL

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

placebo

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

Group Type: EXPERIMENTAL

AZD7442 300 mg IM(male)

Intervention Type: BIOLOGICAL

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

AZD7442 600 mg IM (male)

Intervention Type: BIOLOGICAL

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

AZD7442 300 mg IV (male and female)

Intervention Type: BIOLOGICAL

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

AZD7442 1000 mg IV (male)

Intervention Type: BIOLOGICAL

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

Interventions

AZD7442 300 mg IM(male)

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

Intervention Type: BIOLOGICAL

AZD7442 600 mg IM (male)

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

Intervention Type: BIOLOGICAL

AZD7442 300 mg IV (male and female)

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

Intervention Type: BIOLOGICAL

AZD7442 1000 mg IV (male)

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Fukuoka, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 37524201 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34473343 (View on PubMed)

Other Identifiers

D8850C00005

Identifier Type: -

Identifier Source: org_study_id

NCT05406375

Identifier Type: -

Identifier Source: nct_alias