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

NCT05429021 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: IMM-BCP-1001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

Brief 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

SARS-CoV2 Infection; COVID-19

Keywords

IMM-BCP-01; antibody cocktail

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of Treatment Emergent Adverse Events (TEAEs)

  TEAEs include clinical laboratory values, standard 12-lead ECGs, vital signs, pulse oximetry

  Up to 28 days

Secondary Outcomes (10)

• Incidence and severity of Treatment Emergent Adverse Events (TEAEs)

  Up to 12 weeks

• PK parameters

  Up to 28 days

• PK parameters

  Up to 12 weeks

• PK parameters

  Up to 12 weeks

• PK parameters

  Up to 12 weeks

Study Arms (4)

IV Cohort 1

EXPERIMENTAL

Single intravenous (IV) dose 1 of IMM-BCP-01 or matching placebo

Drug: IMM-BCP-01; Drug: Placebo

IV Cohort 2

EXPERIMENTAL

Single intravenous (IV) dose 2 of IMM-BCP-01 or matching placebo

Drug: IMM-BCP-01; Drug: Placebo

IV Cohort 3

EXPERIMENTAL

Single intravenous (IV) dose 1 of IMM-BCP-01 or matching placebo

Drug: IMM-BCP-01; Drug: Placebo

IV Cohort 4 (optional)

EXPERIMENTAL

Single intravenous (IV) dose 4 of IMM-BCP-01 or matching placebo

Drug: IMM-BCP-01; Drug: Placebo

Interventions

IMM-BCP-01 DRUG

Single dose of IMM-BCP-01

IV Cohort 1; IV Cohort 2; IV Cohort 3; IV Cohort 4 (optional)

Placebo DRUG

Placebo matching single dose of IMM-BCP-01

IV Cohort 1; IV Cohort 2; IV Cohort 3; IV Cohort 4 (optional)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female 18 to 50 years of age, inclusive, at the time of signing the informed consent.
• Subjects must have mild to moderate COVID-19 with symptom onset within 5 days prior to study drug administration (see Appendix 13.1 for Food and Drug Administration \[FDA\] severity guidance). Subjects whose symptoms began \>5 days (i.e. ˃120 hours) prior to dosing or whose time of symptom onset cannot be accurately assessed are not eligible.
• Subjects must have at least 2 of the following COVID-19 symptoms: fever, cough, sore throat, rhinorrhea, malaise, headache, muscle pain, nausea, vomiting, diarrhea, and loss of taste or smell, or other symptoms that the Principal Investigator judges to be referrable to COVID-19.
• Subjects must be able to maintain oxygen saturation (SpO2) ≥ 94% on room air (no supplemental oxygen).
• Body mass index ≥ 18.0 and ≤ 30.0 kg/m2.
• Body weight ≥ 40 kg at screening.
• Sexually active subjects of reproductive potential must agree to use highly effective contraception from signing of the informed consent through 90 days after infusion of the study drug (see Section 7.4).
• Males must agree not to donate sperm from dosing until 90 days after administration of the study drug.
• Subjects must have been in generally good health, as judged by the Principal Investigator, prior to onset of current COVID-19 illness, with no clinically significant medical history.
• Subjects must be without clinically significant abnormalities as assessed by review of medical and surgical history, physical examination, vital signs measurement, ECG, and laboratory evaluations conducted at screening.

You may not qualify if:

• Has one or more symptoms suggestive of more severe illness with COVID-19 and/or requires hospitalization.
• Is asymptomatic at screening or randomization, regardless of a positive COVID-19 test.
• Is at increased risk of severe COVID-19 for any reason including but not limited to: cancer (basal cell carcinoma and prostate carcinoma in situ \[Gleason ≤ 6\] are acceptable), chronic kidney disease, chronic obstructive pulmonary disease, heart condition (congestive heart failure II, III and IV as per New York Heart Association: coronary disease and any other cardiac condition that imposes high risk of developing severe COVID-19), immunocompromised state from solid organ transplant, sickle cell disease, or other condition, autoimmune disease, use of immunosuppressants (including high doses of systemic corticosteroids), type 1 or type 2 diabetes mellitus, current or prior history of smoking or vaping any product, including nicotine or THC.
• Has any active infection, other than the underlying COVID-19.
• Has been admitted to a hospital within 3 months prior to randomization (except for planned admissions for minor procedures).
• Has been hospitalized due to COVID-19 at any time.
• Has participated or is participating in a clinical research study currently or within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit.
• Has received monoclonal antibodies against SARS-CoV-2 and/or COVID-19 convalescent plasma.
• Is anticipated to be treated with any approved or investigational drug or agent against SARS-CoV-2 (other than the study drug) during the study including antiviral drug(s), antibodies, or convalescent plasma.
• Has received any COVID-19 directed treatment in the 3 months prior to the screening visit including but not limited to: Intravenous immunoglobulin, Approved drugs or products used off label for treatment of COVID-19, Other experimental interventions.
• History or suspicion of excessive alcohol use (defined as drinking on average 14 drinks a week for males and 7 drinks a week for females) or of binge drinking (defined as 4 drinks on any day for males and 3 drinks on any day for females, for 5 or more days in the past month)
• History of substance abuse or current use of any drugs of abuse
• Any other condition or prior therapy which the Principal Investigator feels may jeopardize the safety of the subject or the objectives of the study.

Sponsors & Collaborators

• Immunome, Inc.: lead
• United States Department of Defense: collaborator

Study Sites (3)

Ark Clinical Research

Long Beach, California, 90806, United States

Location

Panax Clinical Research

Miami Lakes, Florida, 33014, United States

Location

Icahn School of Medicine at Mt. Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

IMM20184, IMM20190, and IMM20253 drug combination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double Blind, Dose Escalation

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 23, 2022
• Study Start: June 3, 2022
• Primary Completion: January 6, 2023
• Study Completion: January 6, 2023
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)