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

COVID-19 Clinical Trial

Official title:

A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD7442 in Healthy Japanese Participants

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05406375
• Other study ID #: D8850C00005
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 16, 2021
• Est. completion date: June 24, 2022

Study information

• Verified date: May 2022
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 24, 2022
• Est. primary completion date: June 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• AZD7442 300 mg IM(male)
Single dose of 300 mg of AZD7442 or saline placebo on Day 1.
• AZD7442 600 mg IM (male)
Single dose of 600 mg of AZD7442 or saline placebo on Day 1.
• AZD7442 300 mg IV (male and female)
Single dose of 300 mg of AZD7442 or saline placebo on Day 1.
• AZD7442 1000 mg IV (male)
Single dose 1000 mg of AZD7442 or saline placebo on Day 1.

Locations

Country	Name	City	State
Japan	Research Site	Fukuoka-shi

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Pharmacokinetics - Serum Concentration	To evaluate the single-dose PK of AZD7442.	Up to Day361
Primary	Pharmacokinetics - Maximum Serum Concentration	To evaluate the single-dose PK of AZD7442.	Up to Day361
Primary	Pharmacokinetics - Time to Maximum Serum Concentration	To evaluate the single-dose PK of AZD7442.	Up to Day361
Primary	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
Primary	Pharmacokinetics - Area under the plasma concentration-time curve extrapolated to infinity	To evaluate the single-dose PK of AZD7442.	Up to Day361
Primary	Pharmacokinetics - extravascular systemic clearance	To evaluate the single-dose PK of AZD7442.	Up to 361
Primary	Pharmacokinetics -bioavailability	To evaluate the single-dose PK of AZD7442.	Up to Day361
Primary	Pharmacokinetics -extravascular terminal phase volume of distribution	To evaluate the single-dose PK of AZD7442.	Up to Day361
Secondary	The serum neutralizing responses against SARS-CoV-2 using Geometric mean fold rise from baseline	Blood samples as neutralizing responses against SARS-CoV-2 in serum will be collected.	Up to Day361
Secondary	ADA responses to the AZD7442 in serum.	Blood samples for determination of ADA in serum will be assayed by bioanalytical test sites, using an appropriately validated bioanalytical method.	Up to Day361
Secondary	The serum neutralizing responses against SARS-CoV-2 using Geometric mean titre from baseline	Blood samples as neutralizing responses against SARS-CoV-2 in serum will be collected.	Up to Day361