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AZD3152

Phase 1

COVID-19 | Small molecule | Infectious Disease |AstraZeneca PLC|Last Updated: Jun 6, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment98

FDA Designations

No designations recorded

Clinical trial landscape

AZD3152 · 1 trial · 1 indication

Phase 1 1
NCT05872958Dose Exploration Intramuscular/Intravenous Prophylaxis Pharmacokinetic Exposure Response StudyCOVID-19
COMPLETED98 Analytics
PHASE1COMPLETED
Dose Exploration Intramuscular/Intravenous Prophylaxis Pharmacokinetic Exposure Response Study
COVID-19Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with adverse event
Until Day 91

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

Number of participants with serious adverse event
Until Day 365 or early discontinuation visit (EDV [approximately 19 months])

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

Number of participants with adverse event of special interest
Until Day 365 or EDV (approximately 19 months)

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

Serum concentration of AZD3152
Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)

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

Maximum observed concentration (Cmax) of AZD3152
Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)

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

Time to reach maximum observed concentration (tmax) of AZD3152
Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)

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

Terminal elimination half-life (t1/2) of AZD3152
Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)

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

Area under the serum concentration-curve from 0 to the last quantifiable concentration (AUClast) of AZD3152
Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)

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

Area under concentration-time curve from 0 to infinity (AUCinf) of AZD3152
Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)

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

Apparent total body clearance (CL/F) of AZD3152 (IM administration only)
Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)

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

Apparent volume of distribution based on terminal phase (Vz/F) of AZD3152 (IM administration only)
Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)

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

Total body clearance (CL) of AZD3152 (IV administration only)
Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)

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

Volume of distribution based on terminal phase (Vz) of AZD3152 (IV administration only)
Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)

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

Volume of distribution at steady state (Vss) of AZD3152 (IV administration only)
Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)

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

Secondary Endpoints

Number of participants with anti-drug antibody (ADA) to AZD3152
Pre-dose, Days 15, 31, 91, 181, and Day 365
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
AZD3152 Dose X (IM)EXPERIMENTALParticipants will receive dose X of AZD3152 on Day 1 as a single IM injection.
AZD3152 Dose X (IV)EXPERIMENTALParticipants will receive dose X of AZD3152 on Day 1 as an IV infusion.
AZD3152 Dose Y (IM)EXPERIMENTALParticipants will receive dose Y of AZD3152 on Day 1 as 2 sequential IM injections.
AZD3152 Dose Y (IV)EXPERIMENTALParticipants will receive dose Y of AZD3152 on Day 1 as an IV infusion.
AZD3152 Dose Z (IV)EXPERIMENTALParticipants will receive dose Z of AZD3152 on Day 1 as an IV infusion.
Pooled placeboPLACEBO_COMPARATORParticipant will receive placebo on Day 1 either via IM injection or IV infusion.

Interventions

NameTypeDescription
AZD3152DRUGAZD3152 will be administered via IM injection or IV infusion, as per the assigned arms.
PlaceboOTHERPlacebo is a matching volume of 0.9% sodium chloride, will be administered via IM injection or IV infusion, as per the assigned arms.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites4

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 Scre...

Countries:United States
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Frequently asked questions about AZD3152

What is AZD3152 used for?

AZD3152 is an investigational small molecule being developed for COVID-19. It is intended for prophylaxis, meaning it is being studied to prevent COVID-19 infection. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes AZD3152?

AZD3152 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in healthy volunteers.

What phase is AZD3152 in?

AZD3152 is in Phase 1 clinical development. A Phase 1 trial has been completed, which studied the drug's pharmacokinetics and exposure response when administered via intramuscular or intravenous routes. The drug remains investigational and has not received FDA approval.

What clinical trials is AZD3152 in?

AZD3152 has one completed clinical trial registered under NCT05872958. This Phase 1 study, titled "Dose Exploration Intramuscular/Intravenous Prophylaxis Pharmacokinetic Exposure Response Study," enrolled 98 healthy volunteers in the United States. The trial was randomized, double-blind, and placebo-controlled.

Is AZD3152 FDA approved?

AZD3152 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A Phase 1 trial has been completed, but the drug has not yet progressed through the later stages of clinical testing required for regulatory approval.