APC148 / AdjuTec Pharma - LARVOL DELTA

Phase I dose-ascending, safety, and pharmacokinetics study of APC148, a novel metallo-β-lactamase inhibitor, in healthy volunteers. (PubMed, Antimicrob Agents Chemother) - P1 | "APC148 is combined with the broad-spectrum β-lactam antibiotic meropenem and the serine-β-lactamase inhibitor avibactam, which targets Ambler class A, C, and some class D (OXA-48-like) enzymes. All adverse events were of mild intensity, and no serious adverse events or adverse events leading to study or treatment discontinuation occurred. The pharmacokinetics of APC148 were dose-proportional, with low plasma clearance, low-to-moderate volume of distribution, and a mean plasma half-life of 2.6 h. APC148 is well-tolerated and represents a promising candidate in the fight against antibiotic-resistant bacteria.CLINICAL TRIALSThis study is registered with ClinicalTrials.gov as NCT06360640."

First-in-human • Journal • P1 data • PK/PD data • Infectious Disease

Safety and pharmacokinetics of single ascending doses of APC148, a zinc-chelating MBL-inhibitor, in healthy volunteers (ESCMID Global 2025) - No abstract available

Clinical • PK/PD data

Metallo-beta-lactamase inhibitor APC148: impact of choice of Mueller-Hinton broth brand on results from antimicrobial susceptibility testing (ESCMID Global 2025) - No abstract available

APC148-001: A First-in-human Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of APC148 in Healthy Adults (clinicaltrials.gov) - P1 | N=46 | Completed | Sponsor: AdjuTec Pharma AS | Recruiting ➔ Completed

Trial completion

APC148-001: A First-in-human Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of APC148 in Healthy Adults (clinicaltrials.gov) - P1 | N=46 | Recruiting | Sponsor: AdjuTec Pharma AS | Not yet recruiting ➔ Recruiting | Initiation date: Jun 2024 ➔ Sep 2024

Enrollment open • Trial initiation date

A First-in-human Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of APC148 in Healthy Adults (clinicaltrials.gov) - P1 | N=46 | Not yet recruiting | Sponsor: AdjuTec Pharma AS

New P1 trial