ASC10 / Ascletis - LARVOL DELTA

Study to Evaluate Safety, Tolerability, Efficacy and Pharmacokinetics of ASC10 in Mild to Moderate COVID-19 Patients (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Ascletis Pharmaceuticals Co., Ltd. | N=32 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety, tolerability and pharmacokinetics of ASC10, a novel oral double prodrug of a broad-spectrum antiviral agent, β-d-N4-hydroxycytidine: results from a randomized, double-blind, placebo-controlled phase 1 study in Chinese healthy subjects. (PubMed, Expert Opin Investig Drugs) - P1 | "ASC10 was demonstrated to be safe and well-tolerated and exhibited dose-proportional exposure and minimal food effects. www.clinicaltrials.gov identifier is NCT05523141."

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

Ascletis Announces China NMPA Approval of Conducting a Phase IIa Clinical Trial for ASC10 to Treat Respiratory Syncytial Virus Infection (PRNewswire) - "Ascletis Pharma Inc...announces today that the China National Medical Products Administration ('NMPA') has approved to conduct a Phase IIa clinical trial for ASC10 to treat respiratory syncytial virus (RSV) infection. Based on available data, dosage of 800 mg ASC10, twice daily was selected to conduct a randomized, double-blind, placebo-controlled Phase IIa study to evaluate the antiviral activity, safety, tolerability and pharmacokinetics of ASC10 tablets in patients with mild or moderate RSV infection....Preclinical research showed that ASC10-A (NHC) is a potent inhibitor with EC50 of 0.51 to 0.6 uM against two RSV clinical isolates using in vitro infection assay in HEp-2 cells. Furthermore, preclinical research also demonstrated that ASC10-A (NHC) is efficacious in a mouse RSV infection model."

New P2a trial • Preclinical • Infectious Disease

In vivo evaluation of ASC10 against SARS-CoV-2 virus in K18-hACE2 mouse SARS-CoV-2 model (ECCMID 2023) - No abstract available

Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

SAFETY AND PHARMACOKINETICS OF A NOVEL DOUBLE PRODRUG ASC10 IN HEALTHY SUBJECTS (CROI 2023) - "PK blood samples were collected and measured for ASC10-A along with ASC10 and molnupiravir. Results of this study showed that ASC10 was well tolerated, and the increase in plasma exposure of ASC10-A was dose proportional across the range of doses tested with no accumulation and no food effect. 800 mg ASC10 BID is selected for further studies in patients infected with SARS-CoV-2."

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

Study to Evaluate Safety, Tolerability, Pharmacokinetics and the Food Effect on PK of ASC10 Tablets in Healthy Subjects (clinicaltrials.gov) - P1 | N=72 | Completed | Sponsor: Ascletis Pharmaceuticals Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Study to Evaluate Safety, Tolerability, Pharmacokinetics and the Food Effect on PK of ASC10 Tablets in Healthy Subjects (clinicaltrials.gov) - P1 | N=72 | Active, not recruiting | Sponsor: Ascletis Pharmaceuticals Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Study to Evaluate Safety, Tolerability, Efficacy and Pharmacokinetics of ASC10 in Mild to Moderate COVID-19 Patients (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Ascletis Pharmaceuticals Co., Ltd.

New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Study to Evaluate Safety, Tolerability, Pharmacokinetics and the Food Effect on PK of ASC10 Tablets in Healthy Subjects (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Ascletis Pharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Study to Evaluate Safety, Tolerability, Pharmacokinetics and the Food Effect on PK of ASC10 Tablets in Healthy Subjects (clinicaltrials.gov) - P1 | N=72 | Not yet recruiting | Sponsor: Ascletis Pharmaceuticals Co., Ltd.

New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases