Dose Exploration Intramuscular/Intravenous Prophylaxis Pharmacokinetic Exposure Response Study

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05872958
• Other study ID #: D7000C00004
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: May 19, 2023
• Est. completion date: August 16, 2024

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 98
• Est. completion date: August 16, 2024
• Est. primary completion date: August 16, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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

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.

Locations

Country	Name	City	State
United States	Research Site	Anniston	Alabama
United States	Research Site	Cullman	Alabama
United States	Research Site	Orlando	Florida
United States	Research Site	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse event	Evaluation of the safety of IM or IV administration of AZD3152 will be done.	Until Day 91
Primary	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])
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Number of participants with anti-drug antibody (ADA) to AZD3152	Evaluation of ADA responses to AZD3152.	Pre-dose, Days 15, 31, 91, 181, and Day 365