A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD5148 in Healthy Adults
NCT Number: NCT06469151
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Participants
Interventions: DRUG: AZD5148|DRUG: Placebo
Sponsor: AstraZeneca
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 84
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-06-24
Completion Date: 2025-11-21
Locations: Research Site, Anniston, Alabama, 36207, United States|Research Site, Glendale, California, 91206, United States|Research Site, Baltimore, Maryland, 21225, United States|Research Site, San Antonio, Texas, 78229, United States

Summary:
The purpose of this study is to measure safety, tolerability, and pharmacokinetics (PK) of a single dose of AZD5148 administered via intravenous (IV) bolus or intramuscular (IM) injection in healthy participants.

Primary Outcome Measures: Number of participants with adverse events (AEs)., To evaluate the safety and tolerability of AZD5148 administered as a single IV or IM dose to healthy adult participants., From Day -1 to Day 91|Number of participants with serious adverse events (SAEs) and adverse events of special interest (AESIs), To evaluate the safety and tolerability of AZD5148 administered as a single IV or IM dose to healthy adult participants., From Screening (Day -28 to Day -1) to final Follow-up Visit (Day 361 ± 14)
Secondary Outcome Measures: Maximum observed drug concentration (Cmax), To evaluate the single dose PK of AZD5148., From Day 1 until last Follow up visit (Day 361 ± 14 days)|Time to reach maximum observed concentration (tmax), To evaluate the single dose PK of AZD5148., From Day 1 until last Follow up visit (Day 361 ± 14 days)|Time of last quantifiable concentration (tlast), To evaluate the single dose PK of AZD5148., From Day 1 until last Follow up visit (Day 361 ± 14 days)|Terminal elimination half-life, estimated as (ln2)/λz (t1/2λz), To evaluate the single dose PK of AZD5148., From Day 1 until last Follow up visit (Day 361 ± 14 days)|Area under concentration-curve from time 0 to the time of last quantifiable concentration (AUClast), To evaluate the single dose PK of AZD5148., From Day 1 until last Follow up visit (Day 361 ± 14 days)|Area under concentration-time curve from time 0 extrapolated to infinity (AUCinf), To evaluate the single dose PK of AZD5148., From Day 1 until last Follow up visit (Day 361 ± 14 days)|Volume of distribution at steady state (IV administration only) (Vss), To evaluate the single dose PK of AZD5148., From Day 1 until last Follow up visit (Day 361 ± 14 days)|Volume of distribution at terminal phase (IV administration only) (Vz), To evaluate the single dose PK of AZD5148., From Day 1 until last Follow up visit (Day 361 ± 14 days)|Systematic clearance (IV administration only) (CL), To evaluate the single dose PK of AZD5148., From Day 1 until last Follow up visit (Day 361 ± 14 days)|Apparent total body clearance (IM administration only) (CL/F), To evaluate the single dose PK of AZD5148., From Day 1 until last Follow up visit (Day 361 ± 14 days)|Apparent volume of distribution based on the terminal phase (IM administration only) (Vz/F), To evaluate the single dose PK of AZD5148., From Day 1 until last Follow up visit (Day 361 ± 14 days)|Bioavailability for extravascular administration (IM administration only) (F), To evaluate the single dose PK of AZD5148., From Day 1 until last Follow up visit (Day 361 ± 14 days)|Incidence of positive ADAs against AZD5148 in serum, To evaluate the ADA responses to a single IV or IM dose of AZD5148., Day 1 (pre-dose), Day 29, Day 91, Day 181 and Day 361