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NCT06360640

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

A First-in-human, Randomised, Double-blind, Placebo-controlled, Single Ascending Dose Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of APC148 in Healthy Adults
AdjuTec Pharma AS·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Healthy Subjects
Drug/Device/Intervention
APC148 and Placebo
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
AdjuTec Pharma AS
Location
Uppsala, Sweden
Timeline & enrollment
Phase
Phase 1
Start date
Jun 01, 2024
End date
Mar 01, 2025
Enrollment
46 participants
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
Occupational health examinationSeeking and accepting physical, nutritional and chemical interventions known to be hazardous and harmfulRoutine child health examinationExamination and observation for other reasons
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06360640
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.