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Background: LBR-101 is a fully humanized monoclonal antibody that binds to calcitonin gene-related peptide.Objective: The objective of this article is to characterize the safety and tolerability of LBR-101 when administered intravenously to healthy volunteers, by presenting the pooled results of the Phase 1 program.Methods: LBR-101 was administered to 94 subjects, while 45 received placebo. Doses ranged from 0.2 mg to 2000 mg given once (Day 1), as a single IV infusion, or up to 300 mg given twice (Day 1 and Day 14).Results: Subjects receiving placebo reported an average of 1.3 treatment-emerging adverse events vs 1.4 per subject among those receiving any dose of LBR-101, and 1.6 in those receiving 1000 mg or higher. Treatment-related adverse events occurred in 21.2% of subjects receiving LBR-101, compared to 17.7% in those receiving placebo. LBR-101 was not associated with any clinically relevant patterns of change in vital signs, ECG parameters, or laboratory findings. The only serious adverse event consisted of "thoracic aortic aneurysm" in a participant later found to have an unreported history of Ehlers-Danlos syndrome.Conclusion: Single IV doses of LBR-101 ranging from 0.2 mg up to 2000 mg and multiple IV doses up to 300 mg were well tolerated. Overt safety concerns have not emerged. A maximally tolerated dose has not been identified. [ABSTRACT FROM AUTHOR]

The article discusses a study that assesses the effects of sustained calcitonin gene-related peptide (CGRP) inhibition on blood pressure, heart rate, and ECGs in healthy women 40 years of age and below. The study included 31 women who where randomized to receive placebo or an anti-CGRP monoclonal antibody at doses up to 2000 milligrams (mg). It suggests that there is no clinically relevant changes in systolic or diastolic blood pressure, heart rate, or ECG parameters.