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

NCT05429021 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-09-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

IMM-BCP-01

Single dose of IMM-BCP-01

DRUG

Placebo

Placebo matching single dose of IMM-BCP-01

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Immunome, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-03
Primary Completion
2023-01-06
Completion
2023-01-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05429021 on ClinicalTrials.gov