NCT05205668

Study of F-652 in Subjects With Corona Virus Disease 2019 (COVID-19) Pneumonia

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of F-652 in Subjects With COVID-19 Pneumonia

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: EVIVE Biotechnology · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2a, multicenter, randomized, double-blinded, placebo controlled, dose escalation study in adult subjects with COVID-19 pneumonia. The primary objective of this study is to evaluate the overall safety of F-652 in COVID subjects in order to identify safe dose(s) for future studies with adequate patient numbers to demonstrate clinical efficacy.

Detailed description

The study is planned to include 2 cohorts, with enrolled patients being randomized 2:1 in a blinded manner on Day 1, following screening, to F-652 or placebo as follows: * Cohort 1: subjects will receive up to two intravenous (IV) infusions of F-652 at dose 1 or placebo. Upon completion of Cohort 1, the data monitoring committee (DMC) will convene and review all available safety data to determine if the study can proceed to the next dose level. * Cohort 2: subjects will receive up to two IV infusions of F-652 at dose 2 or placebo. Approximately 60 eligible subjects will be enrolled in the study with 30 subjects per dose cohort. Each cohort will have about 20 subjects treated with F-652 and 10 subjects treated with matching placebo. All randomized subjects will receive standard-of-care treatments for COVID-19 per individual institution standards. Treatment will begin on Day 1 following randomization. Subjects will receive up to two IV infusions of F-652 or matching placebo.

Conditions

• COVID-19 Pneumonia

Interventions

Type	Name	Description
BIOLOGICAL	F-652	IL-22 fusion protein administered intravenously
BIOLOGICAL	Placebo	Placebo administered intravenously

Timeline

• Start date: 2022-04-08
• Primary completion: 2022-04-08
• Completion: 2023-04-08
• First posted: 2022-01-25
• Last updated: 2023-10-02

Regulatory

• FDA-regulated drug study