Study Complete
Sponsor ID
20180132

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of AMG 592 in Healthy Japanese Participants

Sponsor ID
20180132
Clinicaltrials.gov ID
NCT05885451
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The primary objective of this study is to characterize the pharmacokinetics (PK) profile of a single dose of

AMG 592 administered subcutaneously in healthy Japanese participants.

Additional Study Details

Phase
Phase 1
Product
AMG 592
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
18
Additional Study Details

Protocol Summary

Primary Outcome Measures

Maximum Observed Serum Concentration (Cmax) of AMG 592

Timeframe: Up to Day 43

Time of Maximum Observed Concentration (tmax) of AMG 592

Timeframe: Up to Day 43

Area Under the Serum Concentration-time Curve to the Last Measurable Point (AUClast) of AMG 592

Timeframe: Up to Day 43

Area Under the Concentration-time Curve (AUC) from Time Zero to Infinity (AUCinf)

Timeframe: Up to Day 43

Secondary Outcome Measures

Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)

Timeframe: Day 1 to Day 43

Number of Participants who Experience Anti-AMG 592 Antibodies Formation

Timeframe: Up to Day 43

Locations

Location
Status
Contact Us
Location
Research Site
Randwick, NSW, Australia, 2031
Status
Recruiting