NCT05139615

A Study to Assess the Hemodynamic Effects, Safety, Tolerability, and Pharmacokinetics of Intravenous APD418 in Adult Participants With Heart Failure With Reduced Ejection Fraction

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Hemodynamic Effects, Safety, Tolerability, and Pharmacokinetics of APD418 in Subjects With Heart Failure With Reduced Ejection Fraction

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, pharmacokinetics, and effect on cardiac function of intravenous APD418 in adult participants with heart failure with reduced ejection fraction (HFrEF).

Detailed description

This study has an adaptive design, in which dose escalation in Part A will inform dose expansion in Part B. Part A is a single-ascending dose, placebo-controlled study planned to consist of 5 cohorts evaluating 5 doses of APD418. Part B is a parallel-treatment group study planned to evaluate 2 doses of APD418 and placebo. Participants in Part A cannot participate in Part B.

Conditions

• Acute Heart Failure With Reduced Ejection Fraction

Interventions

Type	Name	Description
DRUG	APD418	Participants will receive a single dose of APD418 as an intravenous (IV) infusion.
DRUG	APD418	Participants will receive a single dose of APD418 as an IV infusion.
DRUG	Placebo	Participants will receive a single dose of APD418 matching placebo as an IV infusion.

Timeline

• Start date: 2021-12-28
• Primary completion: 2022-09-19
• Completion: 2022-09-19
• First posted: 2021-12-01
• Last updated: 2023-11-09
• Results posted: 2023-11-09

Locations

21 sites across 5 countries: United States, Germany, Greece, Poland, Serbia

Regulatory

• FDA-regulated drug study