QR052107B / Createrna - LARVOL DELTA

A Phase I clinical study of randomized, double-blind, placebo-controlled, dose-escalation to evaluate the safety, tolerability, and pharmacokinetic characteristics of QR052107B tablets after multiple administrations in healthy Chinese adult subjects (ChiCTR) - P1 | N=30 | Completed | Sponsor: The Second Hospital of Anhui Medical University; The Second Hospital of Anhui Medical University

New P1 trial • Chronic Cough • Cough • Pulmonary Disease • Respiratory Diseases

QR052107B Tablets in Patients With Subacute Cough of Phase Ⅱ Study (clinicaltrials.gov) - P2 | N=270 | Completed | Sponsor: Wuhan Createrna Science and Technology Co., Ltd

New P2 trial • Cough • Respiratory Diseases

The fermentation optimization for alkaline protease production by Bacillus subtilis BS-QR-052. (PubMed, Front Microbiol) - "The established model for predicting alkaline protease activity was validated, achieving significantly higher levels of enzymatic activity. The findings provide valuable references for further enhancing the yield and activity of alkaline protease, thereby holding substantial practical significance and economic benefits for industrial applications."

Journal

Createrna Announces Positive Top-Line Results from Phase 1 Clinical Trials of QR052107B Tablet in Healthy Volunteers (PRNewswire) - P1 | N=N/A | "The top-line data from the Phase 1 studies have demonstrated that QR052107B Tablet at a single dose of 25 mg to 800 mg and multiple daily doses of 25 mg to 400 mg up to 14 days was safe and well tolerated by the healthy volunteers. The pharmacokinetic (PK) profile supports once-a-day (QD) dosing regimen. No serious adverse event (SAE) was reported and no subject in QR052107B Tablet treatment group discontinued the studies. In the 94 healthy volunteers enrolled in the Phase 1 studies, no taste alteration adverse events (AE) were reported....Createrna has initiated a Phase 2 study of QR052107B Tablet to treat RCC and UCC in November 2022 with anticipated top-line results to be released in the 2Q of 2024."

P1 data • P2 data • Trial status • Chronic Cough • Cough • Respiratory Diseases