Dose Exploration Intramuscular/Intravenous Prophylaxis Pharmacokinetic Exposure Response Study

NCT05872958 | Completed Phase 1 FDA Drug

• 1 other identifier: D7000C00004
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 4

Brief Summary

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).

Conditions

COVID-19

Keywords

Coronavirus disease 2019 (COVID-19); Prophylaxis setting

Outcome Measures

Primary Outcomes (14)

• Number of participants with adverse event

  Evaluation of the safety of IM or IV administration of AZD3152 will be done.

  Until Day 91

• Number of participants with serious adverse event

  Evaluation of the safety of IM or IV administration of AZD3152 will be done.

  Until Day 365 or early discontinuation visit (EDV [approximately 19 months])

• Number of participants with adverse event of special interest

  Evaluation of the safety of IM or IV administration of AZD3152 will be done.

  Until Day 365 or EDV (approximately 19 months)

• Serum concentration of AZD3152

  Pharmacokinetics (PK) characterization of AZD3152 in serum after a single IM or IV dose.

  Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)

• Maximum observed concentration (Cmax) of AZD3152

  PK (Cmax) characterization of AZD3152 in serum after a single IM or IV dose.

  Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)

• Time to reach maximum observed concentration (tmax) of AZD3152

  PK (tmax) characterization of AZD3152 in serum after a single IM or IV dose.

  Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)

• Terminal elimination half-life (t1/2) of AZD3152

  PK (t1/2) characterization of AZD3152 in serum after a single IM or IV dose.

  Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)

• Area under the serum concentration-curve from 0 to the last quantifiable concentration (AUClast) of AZD3152

  PK (AUClast) characterization of AZD3152 in serum after a single IM or IV dose.

  Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)

• Area under concentration-time curve from 0 to infinity (AUCinf) of AZD3152

  PK (AUCinf) characterization of AZD3152 in serum after a single IM or IV dose.

  Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)

• Apparent total body clearance (CL/F) of AZD3152 (IM administration only)

  PK (CL/F) characterization of AZD3152 in serum after a single IM.

  Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)

• Apparent volume of distribution based on terminal phase (Vz/F) of AZD3152 (IM administration only)

  PK (Vz/F) characterization of AZD3152 in serum after a single IM.

  Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)

• Total body clearance (CL) of AZD3152 (IV administration only)

  PK (CL) characterization of AZD3152 in serum after a single IV.

  Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)

• Volume of distribution based on terminal phase (Vz) of AZD3152 (IV administration only)

  PK (Vz) characterization of AZD3152 in serum after a single IV.

  Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)

• Volume of distribution at steady state (Vss) of AZD3152 (IV administration only)

  PK (Vss) characterization of AZD3152 in serum after a single IV.

  Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)

Secondary Outcomes (1)

• Number of participants with anti-drug antibody (ADA) to AZD3152

  Pre-dose, Days 15, 31, 91, 181, and Day 365

Study Arms (6)

AZD3152 Dose X (IM)

EXPERIMENTAL

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

Drug: AZD3152

AZD3152 Dose X (IV)

EXPERIMENTAL

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

Drug: AZD3152

AZD3152 Dose Y (IM)

EXPERIMENTAL

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

Drug: AZD3152

AZD3152 Dose Y (IV)

EXPERIMENTAL

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

Drug: AZD3152

AZD3152 Dose Z (IV)

EXPERIMENTAL

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

Drug: AZD3152

Pooled placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

AZD3152 DRUG

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

AZD3152 Dose X (IM); AZD3152 Dose X (IV); AZD3152 Dose Y (IM); AZD3152 Dose Y (IV); AZD3152 Dose Z (IV)

Placebo 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.

Pooled placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (4)

Research Site

Anniston, Alabama, 36207, United States

Location

Research Site

Cullman, Alabama, 35055, United States

Location

Research Site

Scottsdale, Arizona, 85260, United States

Location

Research Site

Orlando, Florida, 32819, United States

Location

Related Links

• Redated CSR Synopsis
• Results of this clinical trial are available on www.astrazenecaclinicaltrials.com

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: May 24, 2023
• Study Start: May 19, 2023
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2024
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

US (4)