LY-CovMab / Luye Group - LARVOL DELTA

A Randomized, Double-Blind, Placebo-Controlled, First-in-Human Clinical Trial to Assess Safety, Tolerability, and Pharmacokinetics of LY-CovMab, a Potent Human Neutralizing Antibody Against SARS-CoV-2. (PubMed, Infect Dis Ther) - P1 | "A single dose of LY-CovMab was shown to be safe and well tolerated in Chinese healthy adults. The pharmacokinetic (PK) profiles of LY-CovMab in healthy adults showed typical monoclonal antibody distribution and elimination characteristics. LY-CovMab demonstrated dose proportionality."

Clinical • Journal • P1 data • PK/PD data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Phase I Study of LY-CovMab Injection in Chinese Healthy Subjects (clinicaltrials.gov) - P1; N=42; Active, not recruiting; Sponsor: Luye Pharma Group Ltd.

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease

Boan Biotech to Start Phase II Clinical Trial in U.S. for Neutralizing Antibody Against SARS-CoV-2 (Luye Press Release) - "Luye Pharma Group today announced that its subsidiary Boan Biotech has submitted the investigational new drug (IND) application for a self-developed drug LY-CovMab to the U.S. Food and Drug Administration....Phase I clinical study completed in China demonstrated LY-CovMab has a good safety and tolerability profile. This submission in the U.S. is to start a phase II study evaluating the efficacy, safety, tolerability, pharmacokinetics and immunogenicity of the LY-CovMab injection in patients with mild to moderate COVID-19....In addition to the U.S., phase II clinical studies for LY-CovMab will be conducted in China and Europe, to provide an effective treatment to patients around the globe."

IND • Infectious Disease • Novel Coronavirus Disease