Study Complete
Sponsor ID
20080390

Safety Study of Tezepelumab (AMG 157) in Healthy Adults

Sponsor ID
20080390
Clinicaltrials.gov ID
NCT00972179
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The primary objective is to evaluate the safety, tolerability, and immunogenicity of multiple-dose administration of tezepelumab in healthy adults.

Additional Study Details

Phase
Phase 1
Product
AMG 157
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
49
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Study Documents

Study Synopsis
Available Language(s): English

Locations

No locations found.