Study Complete
Sponsor ID
20200290

Study of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian Participants

Sponsor ID
20200290
Clinicaltrials.gov ID
NCT05056246
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The primary objective of this study is to evaluate the pharmacokinetics (PK) of maridebart cafraglutide after single subcutaneous (SC) administration in healthy Japanese and Caucasian participants.

Additional Study Details

Phase
Phase 1
Product
N/A
Type
Interventional
Masking
None (Open Label)
Enrollment
34
Additional Study Details

Protocol Summary

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of maridebart cafraglutide

Timeframe: Up to approximately 17 weeks

Area Under the Plasma Concentration‑time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of maridebart cafraglutide

Timeframe: Up to approximately 17 weeks

Area Under the Plasma Concentration‑time Curve from Time Zero to Infinity (AUCinf) of maridebart cafraglutide

Timeframe: Up to approximately 17 weeks

Secondary Outcome Measures

Number of Participants who Experienced an Adverse Event (AE)

Timeframe: Up to approximately 17 weeks

Number of Participants with Incidence of Anti-maridebart cafraglutide Antibodies

Timeframe: Up to approximately 17 weeks

Locations

Location
Status
Contact Us
Location
WCCT Global LLC
Cypress, CA, United States, 90630-4738
Status
Recruiting