COVID-19
Conditions
Keywords
Coronavirus disease 2019 (COVID-19), Prophylaxis setting
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).
Interventions
DRUGAZD3152
AZD3152 will be administered via IM injection or IV infusion, as per the assigned arms.
OTHERPlacebo
Placebo is a matching volume of 0.9% sodium chloride, will be administered via IM injection or IV infusion, as per the assigned arms.
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with anti-drug antibody (ADA) to AZD3152 | Pre-dose, Days 15, 31, 91, 181, and Day 365 | Evaluation of ADA responses to AZD3152. |
Countries
United States
Outcome results
None listed