Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05872958 | Dose Exploration Intramuscular/Intravenous Prophylaxis Pharmacokinetic Exposure Response Study | PHASE1 | COMPLETED | 98 | — | — | May 19, 2023 | Aug 20, 2024 | Jun 6, 2025 | 4 | United States |
Evaluation of the safety of IM or IV administration of AZD3152 will be done.
Evaluation of the safety of IM or IV administration of AZD3152 will be done.
Evaluation of the safety of IM or IV administration of AZD3152 will be done.
Pharmacokinetics (PK) characterization of AZD3152 in serum after a single IM or IV dose.
PK (Cmax) characterization of AZD3152 in serum after a single IM or IV dose.
PK (tmax) characterization of AZD3152 in serum after a single IM or IV dose.
PK (t1/2) characterization of AZD3152 in serum after a single IM or IV dose.
PK (AUClast) characterization of AZD3152 in serum after a single IM or IV dose.
PK (AUCinf) characterization of AZD3152 in serum after a single IM or IV dose.
PK (CL/F) characterization of AZD3152 in serum after a single IM.
PK (Vz/F) characterization of AZD3152 in serum after a single IM.
PK (CL) characterization of AZD3152 in serum after a single IV.
PK (Vz) characterization of AZD3152 in serum after a single IV.
PK (Vss) characterization of AZD3152 in serum after a single IV.
| Arm | Type | Description |
|---|---|---|
| AZD3152 Dose X (IM) | EXPERIMENTAL | Participants will receive dose X of AZD3152 on Day 1 as a single IM injection. |
| AZD3152 Dose X (IV) | EXPERIMENTAL | Participants will receive dose X of AZD3152 on Day 1 as an IV infusion. |
| AZD3152 Dose Y (IM) | EXPERIMENTAL | Participants will receive dose Y of AZD3152 on Day 1 as 2 sequential IM injections. |
| AZD3152 Dose Y (IV) | EXPERIMENTAL | Participants will receive dose Y of AZD3152 on Day 1 as an IV infusion. |
| AZD3152 Dose Z (IV) | EXPERIMENTAL | Participants will receive dose Z of AZD3152 on Day 1 as an IV infusion. |
| Pooled placebo | PLACEBO_COMPARATOR | Participant will receive placebo on Day 1 either via IM injection or IV infusion. |
| Name | Type | Description |
|---|---|---|
| AZD3152 | DRUG | AZD3152 will be administered via IM injection or IV infusion, as per the assigned arms. |
| Placebo | OTHER | Placebo is a matching volume of 0.9% sodium chloride, will be administered via IM injection or IV infusion, as per the assigned arms. |
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 Scre...