Dose Exploration Intramuscular/Intravenous Prophylaxis Pharmacokinetic Exposure Response Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-19

Study Completion Date

2024-08-20

Brief Summary

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This is a dose exploration study to evaluate the safety and pharmacokinetics (PK) of AZD3152 in healthy adult male and female participants, across different dose levels and routes of administration (ie, Intramuscular \[IM\] injection and Intravenous \[IV\] infusion).

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Detailed Description

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The study will be conducted in the United States of America.

Eligible healthy participants will be randomized to receive either AZD3152 or placebo administered IM or IV, across 5 fixed-dose cohorts. Participants will receive a single dose of AZD3152/placebo.

Cohort 1: Dose X of AZD3152 or placebo, as an IM injection Cohort 2: Dose X of AZD3152 or placebo, administered IV Cohort 3: Dose Y of AZD3152 or placebo, as an IM injection Cohort 4: Dose Y of AZD3152 or placebo, administered IV Cohort 5: Dose Z of AZD3152 or placebo, administered IV

The study will comprise of:

* A Screening Period of maximum 28 days.
* A Treatment Period of one Day.
* A Follow-up Period of 12 months after study intervention (Day 365).

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AZD3152 Dose X (IM)

Participants will receive dose X of AZD3152 on Day 1 as a single IM injection.

Group Type EXPERIMENTAL

AZD3152

Intervention Type DRUG

AZD3152 will be administered via IM injection or IV infusion, as per the assigned arms.

AZD3152 Dose X (IV)

Participants will receive dose X of AZD3152 on Day 1 as an IV infusion.

Group Type EXPERIMENTAL

AZD3152

Intervention Type DRUG

AZD3152 will be administered via IM injection or IV infusion, as per the assigned arms.

AZD3152 Dose Y (IM)

Participants will receive dose Y of AZD3152 on Day 1 as 2 sequential IM injections.

Group Type EXPERIMENTAL

AZD3152

Intervention Type DRUG

AZD3152 will be administered via IM injection or IV infusion, as per the assigned arms.

AZD3152 Dose Y (IV)

Participants will receive dose Y of AZD3152 on Day 1 as an IV infusion.

Group Type EXPERIMENTAL

AZD3152

Intervention Type DRUG

AZD3152 will be administered via IM injection or IV infusion, as per the assigned arms.

AZD3152 Dose Z (IV)

Participants will receive dose Z of AZD3152 on Day 1 as an IV infusion.

Group Type EXPERIMENTAL

AZD3152

Intervention Type DRUG

AZD3152 will be administered via IM injection or IV infusion, as per the assigned arms.

Pooled placebo

Participant will receive placebo on Day 1 either via IM injection or IV infusion.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo is a matching volume of 0.9% sodium chloride, will be administered via IM injection or IV infusion, as per the assigned arms.

Interventions

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AZD3152

AZD3152 will be administered via IM injection or IV infusion, as per the assigned arms.

Intervention Type DRUG

Placebo

Placebo is a matching volume of 0.9% sodium chloride, will be administered via IM injection or IV infusion, as per the assigned arms.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy male or female participants.
* Participants have suitable veins for cannulation or repeated venipuncture.
* Negative SARS-CoV-2 RT-PCR or SARS-CoV-2 rapid antigen test result at Visit 1.
* Body weight ≥ 45 kg and ≤ 110 kg and body mass index ≥ 18 and \<32 kg/m2 at Screening.
* Able to complete the Follow-up Period up to Day 365 as required by the protocol.

Exclusion Criteria

* History of any clinically important disease or disorder.
* Receipt of any immunoglobulin (either COVID-19 or non-COVID related) or blood products within 6 months prior to Day 1.
* Receipt of an EVUSHELD monoclonal antibody (mAb) against SARS-CoV-2 within last 15 months before Day 1.
* Receipt of a COVID-19 vaccine within 14 days prior to Visit 1.
* SARS-CoV-2 infection within one month prior to Visit 1 (confirmed either by laboratory testing or a rapid test \[including at-home testing\]).
* Women who are pregnant, lactating, or of childbearing potential and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration.
* Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy,
* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention. This includes any acute (time-limited) or febrile (temperature ≥ 38.0°C \[100.4ºF\]) illness/infection on day prior to or day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves within the Screening Period or may be rescreened once.
* Any abnormal laboratory values as described in protocol.
* Any known HIV or hepatitis B or C infection at Screening.
* History of alcohol or substance abuse that in the opinion of the Investigator might interfere with the trial conduct or completion.
* Known hypersensitivity to AZD3152.
* Previous hypersensitivity or severe adverse reaction following administration of a mAb.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes