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

Last updated: September 24, 2024
Sponsor: Immunome, Inc.
Overall Status: Terminated

Phase

1

Condition

Covid-19

Treatment

Placebo

IMM-BCP-01

Clinical Study ID

NCT05429021
IMM-BCP-1001
  • Ages 18-50
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female 18 to 50 years of age, inclusive, at the time of signing the informedconsent.

  2. Subjects must have mild to moderate COVID-19 with symptom onset within 5 days priorto 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 noteligible.

  3. Subjects must have at least 2 of the following COVID-19 symptoms: fever, cough, sorethroat, rhinorrhea, malaise, headache, muscle pain, nausea, vomiting, diarrhea, andloss of taste or smell, or other symptoms that the Principal Investigator judges tobe referrable to COVID-19.

  4. Subjects must be able to maintain oxygen saturation (SpO2) ≥ 94% on room air (nosupplemental oxygen).

  5. Body mass index ≥ 18.0 and ≤ 30.0 kg/m2.

  6. Body weight ≥ 40 kg at screening.

  7. Sexually active subjects of reproductive potential must agree to use highlyeffective contraception from signing of the informed consent through 90 days afterinfusion of the study drug (see Section 7.4).

  8. Males must agree not to donate sperm from dosing until 90 days after administrationof the study drug.

  9. Subjects must have been in generally good health, as judged by the PrincipalInvestigator, prior to onset of current COVID-19 illness, with no clinicallysignificant medical history.

  10. Subjects must be without clinically significant abnormalities as assessed by reviewof medical and surgical history, physical examination, vital signs measurement, ECG,and laboratory evaluations conducted at screening.

Exclusion

Exclusion Criteria:

  1. Has one or more symptoms suggestive of more severe illness with COVID-19 and/orrequires hospitalization.

  2. Is asymptomatic at screening or randomization, regardless of a positive COVID-19test.

  3. 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] areacceptable), chronic kidney disease, chronic obstructive pulmonary disease, heartcondition (congestive heart failure II, III and IV as per New York HeartAssociation: coronary disease and any other cardiac condition that imposes high riskof developing severe COVID-19), immunocompromised state from solid organ transplant,sickle cell disease, or other condition, autoimmune disease, use ofimmunosuppressants (including high doses of systemic corticosteroids), type 1 ortype 2 diabetes mellitus, current or prior history of smoking or vaping any product,including nicotine or THC.

  4. Has any active infection, other than the underlying COVID-19.

  5. Has been admitted to a hospital within 3 months prior to randomization (except forplanned admissions for minor procedures).

  6. Has been hospitalized due to COVID-19 at any time.

  7. Has participated or is participating in a clinical research study currently orwithin 3 months or less than 5 half-lives of the investigational product (whicheveris longer) prior to the screening visit.

  8. Has received monoclonal antibodies against SARS-CoV-2 and/or COVID-19 convalescentplasma.

  9. Is anticipated to be treated with any approved or investigational drug or agentagainst SARS-CoV-2 (other than the study drug) during the study including antiviraldrug(s), antibodies, or convalescent plasma.

  10. Has received any COVID-19 directed treatment in the 3 months prior to the screeningvisit including but not limited to: Intravenous immunoglobulin, Approved drugs orproducts used off label for treatment of COVID-19, Other experimental interventions.

  11. Has received a COVID-19 vaccination within 6 weeks of screening. Subjects vaccinated ≥ 6 weeks prior to screening and who otherwise meet inclusion/exclusion criteria areeligible to participate.

  12. History or suspicion of excessive alcohol use (defined as drinking on average 14drinks 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 5or more days in the past month)

  13. History of substance abuse or current use of any drugs of abuse

  14. Any other condition or prior therapy which the Principal Investigator feels mayjeopardize the safety of the subject or the objectives of the study.

Note: Other protocol defined Inclusion/Exclusion criteria apply

Study Design

Total Participants: 9
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
June 03, 2022
Estimated Completion Date:
January 06, 2023

Study 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.

Connect with a study center

  • Ark Clinical Research

    Long Beach, California 90806
    United States

    Site Not Available

  • Panax Clinical Research

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Icahn School of Medicine at Mt. Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Carolina Phase I Research

    Raleigh, North Carolina 27612
    United States

    Site Not Available

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