NEWS & MEDIA
The clinical trial was approved by the FDA on March 4th 2020, and was transferred to New Zealand due to the pandemic outbreak in the United States, the trial received the New Zealand clinical trial approval in September. The trial is a phase I, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, and pharmacokinetics of HB0017 following a single dose in adult healthy volunteers. HB0017 is a modified IL-17A monoclonal antibody. The initial proposed indications are psoriasis, mandatory spondylitis, and psoriatic arthritis. The application will be further developed in indications such as autoimmune diseases, rheumatic diseases, asthma, and inflammatory bowel disease. During the phase I first in human study, the first thing to evaluate is the safety of a single dose. The starting dose is based on the toxicological studies of cynomolgus monkeys and SD rats with considerably safety window. HB0017 utilizes dose escalation method, starting with the lowest dose, and the subsequent doses will be administered only if the preceding dose is determined to be safe and well tolerated. Each dose cohort for SC administration will consist of a sentinel group of two subjects. The measures above will be taken to ensure the safety of the subjects.