Safety Study of Tezepelumab (AMG 157) in Healthy Adults
Study Details
The primary objective is to evaluate the safety, tolerability, and immunogenicity of multiple-dose administration of tezepelumab in healthy adults.
Protocol Summary
Number of Participants with Treatment-emergent Adverse Events
Timeframe: From first dose of study drug up to day 169
Number of Participants who Developed Anti-tezepelumab Antibodies After Initiation of Treatment
Timeframe: Cohorts 1 to 3 and 6: Days 28, 56, 85, 113, and 169; Cohorts 4 and 5: Days 29, 57, 85, 113, 141, and 169
Time of Maximum Observed Concentration (Tmax) of Tezepelumab
Timeframe: Day 1 predose, end of infusion (EOI; IV cohort only), 4 hours, 3, 7, 14 (Q14D and Q28D only), and 28 days (Q28D only) postdose. Last Dose: Day 57 (Q28D), Day 71 (Q14D) and Day 78 (Q7D) at predose, EOI, 4 hours postdose, 3, 7, 14, 28 days postdose.
Maximum Observed Concentration (Cmax) of Tezepelumab
Timeframe: Day 1 predose, end of infusion (EOI; IV cohort only), 4 hours, 3, 7, 14 (Q14D and Q28D only), and 28 days (Q28D only) postdose. Last Dose: Day 57 (Q28D), Day 71 (Q14D) and Day 78 (Q7D) at predose, EOI, 4 hours postdose, 3, 7, 14, 28 days postdose.
Area Under the Concentration-time Curve Over the Dosing Interval (AUCtau) for Tezepelumab
Timeframe: Day 1 predose, end of infusion (EOI; IV cohort only), 4 hours, 3, 7, 14 (Q14D and Q28D only), and 28 days (Q28D only) postdose. Last Dose: Day 57 (Q28D), Day 71 (Q14D) and Day 78 (Q7D) at predose, EOI, 4 hours postdose, 3, 7, 14, 28 days postdose.
Accumulation Ratio Based on AUCtau
Timeframe: Day 1 predose, end of infusion (EOI; IV cohort only), 4 hours, 3, 7, 14 (Q14D and Q28D only), and 28 days (Q28D only) postdose. Last Dose: Day 57 (Q28D), Day 71 (Q14D) and Day 78 (Q7D) at predose, EOI, 4 hours postdose, 3, 7, 14, 28 days postdose.
Accumulation Ratio Based on Cmax
Timeframe: Day 1 predose, end of infusion (EOI; IV cohort only), 4 hours, 3, 7, 14 (Q14D and Q28D only), and 28 days (Q28D only) postdose. Last Dose: Day 57 (Q28D), Day 71 (Q14D) and Day 78 (Q7D) at predose, EOI, 4 hours postdose, 3, 7, 14, 28 days postdose.