Dose Exploration Intramuscular/Intravenous Prophylaxis Pharmacokinetic Exposure Response Study

Study identifier:D7000C00004

ClinicalTrials.gov identifier:NCT05872958

EudraCT identifier:N/A

CTIS identifier:N/A

Recruitment Complete

Official Title

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

Medical condition

COVID-19

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD3152

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 19 May 2023

Estimated Primary Completion Date: 09 Aug 2024

Estimated Study Completion Date: 09 Aug 2024

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Other

Verification:

Verified 01 Nov 2023 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

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.

No locations available

Arms	Assigned Interventions
Experimental: AZD3152 Dose X (IM) Participants will receive dose X of AZD3152 on Day 1 as a single IM injection.	Drug: AZD3152 AZD3152 will be administered via IM injection or IV infusion, as per the assigned arms.
Experimental: AZD3152 Dose X (IV) Participants will receive dose X of AZD3152 on Day 1 as an IV infusion.	Drug: AZD3152 AZD3152 will be administered via IM injection or IV infusion, as per the assigned arms.
Experimental: AZD3152 Dose Y (IM) Participants will receive dose Y of AZD3152 on Day 1 as 2 sequential IM injections.	Drug: AZD3152 AZD3152 will be administered via IM injection or IV infusion, as per the assigned arms.
Experimental: AZD3152 Dose Y (IV) Participants will receive dose Y of AZD3152 on Day 1 as an IV infusion.	Drug: AZD3152 AZD3152 will be administered via IM injection or IV infusion, as per the assigned arms.
Experimental: AZD3152 Dose Z (IV) Participants will receive dose Z of AZD3152 on Day 1 as an IV infusion.	Drug: AZD3152 AZD3152 will be administered via IM injection or IV infusion, as per the assigned arms.
Placebo Comparator: Pooled placebo Participant will receive placebo on Day 1 either via IM injection or IV infusion.	Other: Placebo Placebo is a matching volume of 0.9% sodium chloride, will be administered via IM injection or IV infusion, as per the assigned arms.

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]