Safety, Tolerability, and Pharmacokinetics of Galcanezumab, an Anti-CGRP Antibody, in Healthy Chinese Participants
Abstract
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 (Cmax) 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 (t1/2) 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.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 30 participants or records.
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