Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study

Summary

AZD3152, a single mAb, is being developed to have broad neutralizing activity across known SARS-CoV-2 variants of concern for pre-exposure prophylaxis of COVID-19.

The aim of the Phase I/III study (Parent Study) will be to evaluate the safety, efficacy and neutralizing activity of AZD3152 compared with comparator for pre exposure prophylaxis of COVID-19, and separately evaluate the safety and PK of AZD5156, a combination of AZD3152 and AZD1061.

Sub-study:

This Phase II sub-study of SUPERNOVA will assess the safety, PK, and predicted neutralizing activity of AZD3152 compared with EVUSHELD for pre-exposure prophylaxis of COVID-19.

Conditions

• COVID-19, SARS-CoV-2

Interventions

BIOLOGICAL

AZD5156 (Parent study Sentinel Safety Cohort)

600 mg AZD5156 consisting of 300 mg AZD1061 at 100 mg/mL and 300 mg AZD3152 at 150 mg/mL 3 mL of AZD1061 2 mL of AZD3152 IM on Visit 1 Day 1

BIOLOGICAL

Placebo (Parent study Sentinel Safety Cohort)

single dose of Placebo (3 mL + 2 mL) IM

BIOLOGICAL

EVUSHELD™ (Parent study Main Cohort)

600 mg EVUSHELD™/AZD7442 consisting of 300 mg AZD1061 and 300 mg AZD8895, both at 100 mg/mL 2 IM injections (thigh) of 3 mL each IM on Visit 1 Day 1 and on Visit 5 Day 181

BIOLOGICAL

AZD3152 (Parent study Main Cohort)

300 mg AZD3152 at 150 mg/mL 1 IM injection (thigh) of 2 mL of AZD3152 on Visit 1 Day 1 and on Visit 5 Day 181

BIOLOGICAL

Placebo (Parent study Main Cohort)

Single doses of 0.9% sodium chloride 2 mL IM for injection on Visit 1 Day 1 and Visit 5 Day 181

BIOLOGICAL

AZD3152 (Sub-study)

Single dose of 1200 mg IV at Visit 1 Day 1

BIOLOGICAL

AZD7442 - EVUSHELD™ (Sub-study)

Single dose 300 mg IM administered on Visit 1 Day 1

BIOLOGICAL

AZD7442 (EVUSHELD™) (Sub-study) Immunocompromised participants offered AZD3152

Single dose of AZD7442 (EVUSHELD™) 300 mg IM

Sponsors & Collaborators

• AstraZeneca

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

130 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-12-16

Primary Completion

2024-03-29

Completion

2025-02-11

FDA Drug

Yes

Countries

• United States
• Australia
• Belgium
• Canada
• Denmark
• France
• Germany
• Israel
• Malaysia
• Poland
• Singapore
• South Korea
• Spain
• Taiwan
• Thailand
• United Arab Emirates
• United Kingdom
• Vietnam

Study Locations