A First-in-human Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of APC148 in Healthy Adults - Trial NCT06360640
Access comprehensive clinical trial information for NCT06360640 through Pure Global AI's free database. This Phase 1 trial is sponsored by AdjuTec Pharma AS and is currently Not yet recruiting. The study focuses on Healthy Subjects. Target enrollment is 46 participants.
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Study Focus
Sponsor & Location
AdjuTec Pharma AS
Timeline & Enrollment
Phase 1
Jun 01, 2024
Mar 01, 2025
Primary Outcome
Incidence and intensity of adverse events (AEs),Incidence and intensity of serious adverse events (SAEs),Incidence and intensity of infusion-related AEs,Time course of local tolerability reactions,Changes from baseline in blood pressure,Changes from baseline in respiratory rate,Changes from baseline in body temperature,Changes from baseline in heart rate,Changes from baseline in PQ/PR interval,Changes from baseline in QRS interval,Changes from baseline in QT interval,Changes from baseline in QTcF interval,Changes from baseline in Clinical Laboratory Profile,Changes from baseline in physical examination
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06360640
Non-Device Trial