NEWS & MEDIA
NEWS & MEDIA
Huaota's first oversea project HB0017 injection started phase I clinical trial and completed the first participant administration on October 20, 2020 successfully
The HB0017 injection project was independently developed by Huaota and approved by the FDA for clinical trials on March 4, 2020. It was transferred to New Zealand for Phase Ia study due to the Covid epidemic in the United States, and was approved for clinical trials in New Zealand in September of the same year. It was a randomized, double-blinded, placebo-controlled, dose-escalating Phase I clinical trial for the safety, tolerability and pharmacokinetics of a single injection of HB0017 in healthy adult participants.
HB0017 is an IL-17A monoclonal antibody. Proposed indications include psoriasis, ankylosing spondylitis and psoriatic arthritis. HB0017 will be further developed for other autoimmune diseases including rheumatic diseases, asthma, psoriatic arthritis and inflammatory bowel disease etc. In the first-in-human Phase I clinical trial, the safety of a single dose will be evaluated, and the starting dose was based on toxicological studies in cynomolgus monkeys and rats with a considerable safety window. The dose escalation method was used starting from a low dose and escalating to higher doses only after the safety assessments. Moreover, each dose group contains 2 "sentinel" subjects. The above measures are taken to ensure the safety of the subjects.