Brief report on a phase I/IIa study to assess the safety, tolerability, and immune response of AGMG0201 in patients with essential hypertension

Abstract

We have been developing an angiotensin II vaccine for hypertension. We conducted a placebo-controlled dose escalation study to investigate the safety, tolerability, and immunological responses of this angiotensin II vaccine (AGMG0201). AGMG0201 was administered to participants with mild to moderate hypertension between 18 and 79 years of age. Twelve patients each were enrolled in the low-dose and high-dose groups. Within each group, subjects were randomly assigned to receive either the active study drug or a placebo at a ratio of 3:1. Each participant received a single intramuscular injection, followed by a second injection 30 days later, and was monitored for 360 days after the second dose. The results showed that most treatment-related adverse events were classified as mild or moderate in severity, including pain and erythema at the injection site. Anti-angiotensin II antibodies were observed in the AGMG0201 patients, especially in the high-dose group. Overall, AGMG0201 was well tolerated.