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Dose Exploration Intramuscular/Intravenous Prophylaxis Pharmacokinetic Exposure Response Study | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Dose Exploration Intramuscular/Intravenous Prophylaxis Pharmacokinetic Exposure Response Study

A Phase I, Randomized, Safety and Pharmacokinetics Study of AZD3152 in Healthy Adults (Little DIPPER)

NCT05872958•AstraZeneca

View on ClinicalTrials.gov

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).

Detailed 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).

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

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.
+3 more criteria

Locations (4)

Research Site

Anniston, Alabama, United States

Research Site

Cullman, Alabama, United States

Research Site

Scottsdale, Arizona, United States

Research Site

Orlando, Florida, United States

Key Dates

Start Date

May 19, 2023

Primary Completion Date

August 20, 2024

Completion Date

August 20, 2024

Last Updated

June 6, 2025

Enrollment

ACTUAL participants

Conditions

COVID-19

Interventions

AZD3152

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Dose Exploration Intramuscular/Intravenous Prophylaxis Pharmacokinetic Exposure Response Study

Inclusion Criteria

Exclusion Criteria

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