9MW1411 / Mabwell (Shanghai) Biosci - LARVOL DELTA

A randomised, double-blind, placebo-controlled, first-in-human phase I study to characterize the safety, pharmacokinetics, and immunogenicity of 9MW1411 in healthy Chinese subjects. (PubMed, Int J Antimicrob Agents) - "9MW1411 has shown a good safety profile in healthy Chinese subjects after single dose up to 5000 mg. Single dose of 3000 mg 9MW1411 is appropriate for use in subsequent studies."

Journal • P1 data • PK/PD data

Glycosaminoglycans from the Starfish Lethasterias fusca: Structures and Influence on Hematopoiesis. (PubMed, Mar Drugs) - "The main fraction LF, having MW 14.5 kDa and dispersity 1.28 (data of gel-permeation chromatography), was solvolytically desulfated and giving rise to preparation LF-deS with a structure of dermatan core [→3)-β-d-GalNAc-(1→4)-α-l-IdoA-(1→], which was identified according to NMR spectroscopy data...Preparations LF and LF-deS were studied as stimulators of hematopoiesis in vitro. Surprisingly, it was found that both preparations were active in these tests, and hence, the high level of sulfation is not necessary for hematopoiesis stimulation in this particular case."

Journal • Hematological Disorders

A Clinical Study in Health Subjects to Evaluate 9MW1411 Injection (clinicaltrials.gov) - P1 | N=42 | Completed | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Feb 2022 ➔ Aug 2021 | Trial primary completion date: Dec 2021 ➔ Aug 2021

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease

A Phase Ⅱ Clinical Study of 9MW1411 Injection in Acute Bacterial Skin and Skin Structure Infections (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

New P2 trial • Dermatology • Infectious Disease