Study Complete
Sponsor ID
20210186

A Study to Evaluate Rocatinlimab (AMG 451) in Healthy Chinese Participants

Sponsor ID
20210186
Clinicaltrials.gov ID
NCT06214481
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The primary objective of the study is to evaluate the pharmacokinetics of rocatinlimab after single subcutaneous (SC) administration in healthy Chinese participants.

Additional Study Details

Phase
Phase 1
Product
Rocatinlimab
Type
Interventional
Masking
None (Open Label)
Enrollment
20
Additional Study Details

Protocol Summary

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of Rocatinlimab

Timeframe: Up to day 126

Area Under the Serum Concentration Time Curve (AUC) from Time Zero to the Time of the Last Measurable Concentration (AUClast) of Rocatinlimab

Timeframe: Up to day 126

AUC from Time Zero to Infinity (AUCinf) of Rocatinlimab

Timeframe: Up to day 126

Secondary Outcome Measures

Number of Participants Experiencing Treatment-emergent Adverse Events

Timeframe: Up to day 126

Number of Participants Experiencing Serious Adverse Events

Timeframe: Up to day 126

Number of Participants who Develop Anti-rocatinlimab Antibodies

Timeframe: Up to day 126

Locations

Location
Status
Contact Us
Location
Huashan Hospital Affiliated to Fudan University?
Shanghai, China, 200040
Status
Recruiting