Safety, Tolerability, and Pharmacokinetics of Galcanezumab, an Anti-CGRP Antibody, in Healthy Chinese Participants.

Galcanezumab is used in several regions, including the United States, Europe, and China, as a preventive treatment for migraine. This study aimed to evaluate the safety, tolerability, and pharmacokinetics (PK) of galcanezumab in healthy Chinese participants. In this phase I single-dose study, 30 healthy adults were assigned to one of the two cohorts (120 or 240 mg) and randomized in a 4:1 ratio to receive a single subcutaneous (SC) dose of galcanezumab or placebo. Overall, 29 (96.7%) participants reported 93 treatment-emergent adverse events (TEAEs), with 21 participants reporting 44 TEAEs related to the study treatment. Most study-related TEAEs (95%) were mild in severity. The most commonly reported TEAE was upper respiratory tract infection. The PK data demonstrated that maximum observed drug concentration (C_max) and area under the serum concentration curve from time zero to infinity increased proportionally to dose, with an apparent clearance of 0.009 L/h and a terminal elimination half-life (t_1/2) of 27 days. Galcanezumab was safe and well tolerated and demonstrated a PK profile consistent with that of non-Chinese populations, supporting its use for the preventive treatment of migraine in Chinese patients.