Phase II Randomized Study of 9MW3811 Intravenous Treatment for Patients With Pathological Scars Evaluating Safety, Tolerability, and Effectiveness

What this Trial Is About

Researchers are evaluating the drug 9MW3811 in a randomized, double-blind, placebo-controlled Phase II study involving patients with pathological scars. The study aims to assess the drugs safety, tolerability, pharmacokinetics, immunogenicity, and preliminary effectiveness in improving scar conditions. Participants will have scars that have not improved spontaneously in the past six months and meet certain severity criteria. Participants will receive multiple intravenous infusions of either low, middle, or high doses of 9MW3811 or a matching placebo according to the study protocol. The treatment phase includes administration over a period up to 12 weeks, with dosing schedules designed to monitor responses and side effects closely. The study compares the effects of the different dosage levels of 9MW3811 against placebo. During the study, participants will undergo regular assessments including modified Vancouver Scar Scale scoring, patient and observer scar evaluations, quality of life questionnaires, vital sign checks, physical exams, ECGs, and laboratory tests. Pharmacokinetic properties such as plasma concentration and antibody development will be monitored up to day 85. The study includes careful safety monitoring and will follow participants for up to 12 weeks after treatment begins.

A Phase II Study of 9MW3811 in Patients With Pathological Scar