Minghui Pharmaceutical has dosed the first healthy volunteer in a Phase Ia trial of MHB018A to treat thyroid eye disease (TED).
The vehicle-controlled, randomised, double-blinded study intends to demonstrate the tolerability, pharmacokinetics, and safety of MHB018A in healthy volunteers.
The new fusion protein of human Fc and humanised single domain IGF-1R antibody MHB018A is administered to the patients subcutaneously.
It demonstrated three to five times greater ligand blocking activities compared to other IGF-1R antibodies for IGF-1, as well as IGF-2.
The molecule also has 150mg/ml solubility, making it suitable for subcutaneous formulation/administration.
In addition, MHB018A demonstrated an excellent safety profile, with NOAEL determined at 150 mg/kg in a preclinical GLP-tox study.
Minghui Pharmaceutical CEO Guoqing Cao said: “The superior biological activity, druggability, and excellent safety of MHB018A demonstrated in preclinical studies suggest potential better clinical benefits for TED patients.
“These exceptional attributes underscore the potential of MHB018A as a leading therapy for the treatment of TED.
“We look forward to the results of the Phase Ia study, as well as the subsequent Phase Ib study involving TED patients, which is expected to conclude in early 2024.”
Last month, Minghui announced top line positive data from its Phase II trial of MH004 Cream to treat adolescents and adults with mild-to-moderate atopic dermatitis.
The trial met its primary endpoint of mean percentage changes from baseline in EASI score. It also met the complete secondary endpoints, including IGA-TS and Eczema Area and Severity Index (EASI)-75 response.