Dose Exploration Intramuscular/Intravenous Prophylaxis Pharmacokinetic Exposure Response Study

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: COVID-19

Treatments: Drug: AZD3152; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05872958

D7000C00004

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 98 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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98 participants in 6 patient groups, including a placebo group

AZD3152 Dose X (IM)

Experimental group

Description:

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

Treatment:

Drug: AZD3152

AZD3152 Dose X (IV)

Experimental group

Description:

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

Treatment:

Drug: AZD3152

AZD3152 Dose Y (IM)

Experimental group

Description:

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

Treatment:

Drug: AZD3152

AZD3152 Dose Y (IV)

Experimental group

Description:

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

Treatment:

Drug: AZD3152

AZD3152 Dose Z (IV)

Experimental group

Description:

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

Treatment:

Drug: AZD3152

Pooled placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo