KFP-H018 / Carephar Pharma - LARVOL DELTA

A Study on the Safety, Pharmacokinetics, and Pharmacodynamics of H018 Tablets, a Selective JAK1 Inhibitor, Upon Single- and Multiple-Dose Administration in Chinese Healthy Subjects. (PubMed, Clin Drug Investig) - "H018 tablets exhibited a rapid onset of action upon oral administration, and the peak inhibition rate was attained approximately 1 h after administration. H018 demonstrated favorable safety and tolerability profiles within the tested dose range, showing potential as a therapeutic option for rheumatoid arthritis treatment."

Clinical • Journal • PK/PD data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • JAK1 • STAT1

A Randomized, Double-Blind, Placebo-Controlled Phase Ib Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of Multiple Topical Administrations of H018 Ointment in Healthy Adult Subjects (ChiCTR) - P1 | N=24 | Not yet recruiting | Sponsor: Institute of dermatologyhinese academy of medical sciences; Jiangsu Carephar Pharmaceutical Co., Ltd

New P1 trial • Dermatology • Immunology • Vitiligo

Phase I clinical study of tolerability, safety, and pharmacokinetic profile of H018 ointment in a single topical administration in healthy Chinese adult subjects (ChiCTR) - P1 | N=40 | Sponsor: Institute of dermatologyhinese academy of medical sciences; Jiangsu Carephar Pharmaceutical Co., Ltd

New P1 trial • Dermatology • Immunology • Vitiligo

Population Pharmacokinetic/Pharmacodynamic Modeling of H018, a Selective JAK1 Inhibitor, in Healthy Chinese Volunteers. (PubMed, Eur J Pharm Sci) - "In the simulation using the final model, the inhibitory effect appeared to have reached a plateau in the high-dose groups, with max inhibition rates of 81.42%, 88.42%, and 91.89% for 80, 120, and 160 mg dose groups, respectively. Taken together, this study will provide an instructive reference of dose selection for subsequent clinical trials."

Journal • PK/PD data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology