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

AstraZeneca1 site in 1 country98 target enrollmentStarted: May 19, 2023Last updated: June 6, 2025

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Completed
Sponsor: AstraZeneca
Enrollment: 98
Locations: 1
Primary Endpoint: Terminal elimination half-life (t1/2) of AZD3152

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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).

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).

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Other
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages: 18 Years to 55 Years (Adult)
Sex: All
Accepts 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
•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
•Receipt of an EVUSHELD monoclonal antibody (mAb) against SARS-CoV-2 within last 15 months before Day
•Receipt of a COVID-19 vaccine within 14 days prior to Visit
•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 AZD
•Previous hypersensitivity or severe adverse reaction following administration of a mAb.

Arms & Interventions

AZD3152 Dose X (IV)

Experimental

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

Intervention: AZD3152 (Drug)

AZD3152 Dose Y (IM)

Experimental

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

Intervention: AZD3152 (Drug)

AZD3152 Dose X (IM)

Experimental

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

Intervention: AZD3152 (Drug)

AZD3152 Dose Y (IV)

Experimental

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

Intervention: AZD3152 (Drug)

AZD3152 Dose Z (IV)

Experimental

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

Intervention: AZD3152 (Drug)

Pooled placebo

Placebo Comparator

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

Intervention: Placebo (Other)