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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: COVID-19

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04896541

D8850C00005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

40 participants in 2 patient groups

AZD7442

Experimental group

Description:

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

Treatment:

Biological: AZD7442 600 mg IM (male)

Biological: AZD7442 300 mg IM(male)

Biological: AZD7442 1000 mg IV (male)

Biological: AZD7442 300 mg IV (male and female)

placebo

Experimental group

Description:

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

Treatment:

Biological: AZD7442 600 mg IM (male)

Biological: AZD7442 300 mg IM(male)

Biological: AZD7442 1000 mg IV (male)

Biological: AZD7442 300 mg IV (male and female)