Trials / Completed
CompletedNCT06360640
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- AdjuTec Pharma AS · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
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.
Detailed description
Participants will receive a single 3-hours IV infusion of APC148 or placebo. 6 sequential cohorts are planned. The first 2 subjects in each cohort will be dosed in a sentinel fashion. The subjects will be followed for 7 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | APC148 and Placebo | IV infusion |
Timeline
- Start date
- 2024-09-02
- Primary completion
- 2025-03-10
- Completion
- 2025-03-10
- First posted
- 2024-04-11
- Last updated
- 2025-03-12
Locations
1 site across 1 country: Sweden
Source: ClinicalTrials.gov record NCT06360640. Inclusion in this directory is not an endorsement.