Phase 1
Completed N=224
Study to Evaluate Pharmacokinetic Comparability Between AZD7442 Co-formulation (AZD8895 + AZD1061) vs AZD8895 and AZD1061 Individually in Adult Healthy Participants
Corona Virus Disease
Source: ClinicalTrials.gov NCT05166421 ↗
Enrolled (actual)
224
Serious AEs
1.3%
Results posted
Nov 2024
Primary outcomePrimary: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) — 4642; 4980; 4666; 2357 day*μg/mL
Summary
The study will assess pharmacokinetic (PK) comparability between different formulations of AZD7442, which is a combination of two individual monoclonal antibodies (mAbs), AZD8895 and AZD1061.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) |
4642; 4980; 4666; 2357; 2634; 2405 | — |
| PRIMARY Area Under the Serum Concentration-time Curve From Day Zero to the Last Measurable Concentration (AUClast) |
4362; 4685; 4406; 2148; 2464; 2254 | — |
| PRIMARY Maximum Observed Serum (Peak) Concentration (Cmax) |
37.60; 36.48; 37.76; 18.69; 19.25; 19.37 | — |
| SECONDARY Time to Maximum Observed Serum Concentration (Tmax) |
13.03; 14.00; 8.05; 13.02; 13.98; 8.05 | — |
| SECONDARY Area Under the Serum Concentration-time Curve From Day Zero to 30 Days Post-dose (AUC0-31d) |
903.4; 887.9; 914.2; 447.0; 468.9; 461.7 | — |
| SECONDARY Area Under the Serum Concentration-time Curve From Day Zero to 60 Days Post-dose (AUC0-61d) |
1771; 1752; 1757; 871.4; 918.9; 886.9 | — |
| SECONDARY Area Under the Serum Concentration-time Curve From Day Zero to 90 Days Post-dose (AUC0-91d) |
2444; 2453; 2430; 1201; 1283; 1227 | — |
| SECONDARY Area Under the Serum Concentration-time Curve From Day Zero to 180 Days Post-dose (AUC0-181d) |
3650; 3788; 3655; 1797; 1981; 1856 | — |
| SECONDARY Time of Last Quantifiable Concentration (Tlast) |
357.98; 358.02; 357.16; 357.98; 358.02; 357.05 | — |
| SECONDARY Terminal Half-life (t½λz) |
75.13; 81.22; 76.52; 77.77; 83.73; 79.19 | — |
| SECONDARY Apparent Clearance After Extravascular Administration (CL/F) |
0.06462; 0.06024; 0.06429; 0.06364; 0.05695; 0.06236 | — |
| SECONDARY Volume of Distribution Based on Terminal Phase After Extravascular Administration (Vz/F) |
6.960; 7.058; 7.098; 7.129; 6.880; 7.125 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
21; 21; 26; 2; 0; 1 | — |
| SECONDARY Number of Participants With Positive Anti-AZD8895 and Anti-AZD1061 Antibodies |
6; 2; 2; 7; 2; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy participants according to medical history, physical examination, and baseline safety laboratory tests.
- Documented negative results of a Severe Acute Respiratory Syndrome Corona Virus 2 reverse transcriptase polymerase chain reaction (SARS-CoV-2 RT-PCR) test collected ≤ 3 days prior to investigational medicinal drug (IMP) dose administration (Day 1) or a negative rapid SARS-CoV-2 antigen test on Day 1 (pre-dose).
- Able to complete the Follow-up period up to Day 361 as required by the protocol.
- Body weight ≥ 50 kg to ≤ 110 kg at screening and a Body mass index ≥ 18.0 to ≤ 30 kg/m^2 at the time of the Screening Visit.
Exclusion Criteria
- Known history of allergy or reaction to any component of AZD7442 (AZD8895 + AZD1061).
- History of infection with SARS or Middle East Respiratory Syndrome.
- Positive SARSCoV-2 result based on available data at screening or at Day 1.
- Any clinical signs and symptoms consistent with Corona virus disease 2019 (COVID-19), eg, fever, dry cough, dyspnea, sore throat, fatigue, or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or on admission.
- History of clinically significant bleeding disorder.
- Active infection with hepatitis B or C or positive test for hepatitis C or for hepatitis B surface antigen at screening.
- Immunodeficiency due to illness, including HIV infection, or due to drugs, including any course of glucocorticoid therapy exceeding 2 weeks of prednisone.
- Any other significant disease, disorder, or finding that may significantly increase the risk to the participant because of participation in the study
- Any prior receipt of another mAb indicated for the prevention or treatment of SARS CoV-2 or COVID-19.
- Receipt of a mAb within 6 months or 5 antibody half-lives.
- Receipt of a COVID-19 vaccination ≤ 14 days before IMP administration (Day 1) or plan to receive a COVID-19 vaccination ≤ 14 days after IMP dose (such participants can subsequently be included in the study once they have reached > 14 days after their last dose of vaccine).
Data sourced from ClinicalTrials.gov (NCT05166421). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.