A First-in-human Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of APC148 in Healthy Adults

Phase 1 Completed 46 enrolled AdjuTec Pharma AS CTC Clinical Trial Consultants AB · collab

RandomizedSequentialDouble-blindBasic science

Summary

The purpose of this first-in-human trial is to investigate the safety, tolerability, and pharmacokinetics of APC148 after intravenous (IV) infusion of single ascending doses in healthy adults.

Timeline

Start: 2024-09-02
Primary completion: 2025-03-10
Completion: 2025-03-10

Publications

Bolstad B, Hovland R, Bylund J, Rein-Hedin E, Kuusk S, Klem B, Rongved P. Phase I dose-ascending, safety, and pharmacokinetics study of APC148, a novel metallo-beta-lactamase inhibitor, in healthy volunteers. Antimicrob Agents Chemother. 2026 Jun 17:e0042626. doi: 10.1128/aac.00426-26. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	APC148	Unknown	50 mg	Intravenous
Subject	APC148	Unknown	150 mg	Intravenous
Subject	APC148	Unknown	300 mg	Intravenous
Subject	APC148	Unknown	450 mg	Intravenous
Subject	APC148	Unknown	600 mg	Intravenous
Subject	APC148	Unknown	900 mg	Intravenous

Indications

No indication recorded.