NCT05429021

IMM-BCP-01 in Mild to Moderate COVID-19

A Randomized, Double-Blind, Placebo-Controlled, First-in-Human, Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Viral Clearance of Single Ascending Doses of IMM-BCP-01 Administered Intravenously in Adults With Mild to Moderate COVID-19

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Immunome, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety and tolerability of intravenous (IV) IMM-BCP-01 in subjects with mild to moderate COVID-19 through Day 28. The secondary objectives of the study are to: * Determine pharmacokinetics (PK) and evaluate viral clearance after single ascending doses of IV IMM-BCP-01 in subjects with mild to moderate COVID-19 through Day 28. * Evaluate the safety and tolerability, determine PK, and evaluate viral clearance of single ascending doses of IV IMM-BCP-01 in subjects with mild to moderate COVID-19 through Week 12.

Detailed description

This is a randomized, double-blind, placebo-controlled Phase 1 study to evaluate the safety, PK, and viral clearance of single ascending doses of IV IMM-BCP-01 in subjects with mild to moderate COVID-19 caused by infection with SARS-CoV-2 and/or its variants. The study will consist of a screening period of up to 36 hours, a treatment period of one day, two further clinic visits, four visits that will take place either in the clinic or at the subject's home, six virtual visits (telephone or video), and an end-of-study visit 12 weeks (+/- 5 days) after study drug dosing. The total duration of a subject's participation is approximately 90 days. Subjects presenting at the clinic with signs and symptoms of mild to moderate COVID-19 and agreeing to participate in the study will be screened, and if deemed eligible for the study, will be randomized (2:1) to receive a single IV dose of IMM-BCP-01 or placebo on Day 1. Subjects at risk of severe disease and those who have been vaccinated against COVID-19 within 6 weeks prior to screening or who have received monoclonal antibodies against SARS-CoV-2 and/or COVID-19 convalescent plasma at any time will not be eligible. Subjects will be randomized to receive IMM BCP-01 or placebo.

Conditions

• SARS-CoV2 Infection
• COVID-19

Interventions

Type	Name	Description
DRUG	IMM-BCP-01	Single dose of IMM-BCP-01
DRUG	Placebo	Placebo matching single dose of IMM-BCP-01

Timeline

• Start date: 2022-06-03
• Primary completion: 2023-01-06
• Completion: 2023-01-06
• First posted: 2022-06-23
• Last updated: 2024-09-26

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study