NBL-012 / CSPC Pharma - LARVOL DELTA

First-in-human study to evaluate the safety, tolerability, and pharmacokinetics of NBL-012, a novel anti-IL-23p19 monoclonal antibody, in healthy subjects (EADV 2024) - P1 | "Preclinical studies demonstrated that NBL-012 exhibits high binding affinity to human IL-23 (KD: 45.1 vs 96.9 pM for guselkumab) and potently inhibits IL-23-induced STAT3 signaling (IC50: 157.4 vs 72.5 pM for guselkumab) . Single doses of NBL-012 up to 400 mg exhibited a favorable safety and tolerability profile in healthy Chinese subjects. NBL-012 displayed linear pharmacokinetics, a prolonged half-life supporting once-quarterly dosing, and superior exposure which may be advantageous for certain inflammatory indications requiring higher doses. These results support further clinical development of NBL-012."

Clinical • P1 data • PK/PD data • CNS Disorders • Dermatology • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Insomnia • Leukopenia • Psoriasis • Sleep Disorder • IL23A

A Study of NBL-012 in Healthy Chinese Subjects (clinicaltrials.gov) - P1 | N=52 | Completed | Sponsor: NovaRock Biotherapeutics, Ltd | Active, not recruiting ➔ Completed

Trial completion • IL23A