recombinant human HGF (E3112) / Eisai - LARVOL DELTA

Nonclinical immunogenicity assessment of E3112, a recombinant human hepatocyte growth factor, and its impact on pharmacokinetics in rats and monkeys. (PubMed, J Pharm Biomed Anal) - "The administration of E3112 resulted in an increase in ADA levels, with higher levels observed in rats than in monkeys. Systemic exposures of E3112 in rats with higher ADA levels were lower than those with lower ADA, confirming the utility of nonclinical immunogenicity in interpreting pharmacokinetics and its inter-individual variability."

Journal • PK/PD data • Preclinical • Hepatology • Liver Failure • HGF

Nonclinical pharmacokinetics of E3112, a recombinant human hepatocyte growth factor, in rats and monkeys by a simple ELISA kit assay. (PubMed, J Pharmacol Toxicol Methods) - "Nonlinear PK of E3112 was observed in rats after intravenous bolus dose at 1-100 mg/kg while nonlinear PK was not significant in monkeys after intravenous infusion at 0.5-25 mg/kg. These findings suggest that the assay of E3112 in serum using a commercially available ELISA kit was validated and successfully applied to PK studies in rats and monkeys."

Journal • PK/PD data • Preclinical • Hepatology • Liver Failure • HGF

Serum APOA4 Pharmacodynamically Represents Administered Recombinant Human Hepatocyte Growth Factor (E3112). (PubMed, Int J Mol Sci) - "APOA4 was identified as a soluble PD marker of rh-HGF with c-Met dependency. It should be worthwhile to clinically validate its utility through clinical trials with healthy subjects and ALF patients."

Journal • PK/PD data • Hepatology • Liver Failure • HGF

A Single Intravenous Dose of E3112 in Japanese Healthy Adult Male Participants (clinicaltrials.gov) - P1; N=24; Completed; Sponsor: EA Pharma Co., Ltd.; Recruiting ➔ Completed; Trial completion date: Jul 2020 ➔ Oct 2020

Clinical • Trial completion • Trial completion date

A Single Intravenous Dose of E3112 in Japanese Healthy Adult Male Participants (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: EA Pharma Co., Ltd.; Trial completion date: Dec 2019 ➔ Jul 2020; Trial primary completion date: Dec 2019 ➔ Jul 2020

Clinical • Trial completion date • Trial primary completion date