SARS-CoV2 InfectionPhase 1NCT05429021
IMM-BCP-01 in Mild to Moderate COVID-19
A Phase 1 study testing IMM-BCP-01 in people with SARS-CoV2 Infection and COVID-19, run by Immunome, Inc. at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- SARS-CoV2 Infection, COVID-19
- What is being tested?
- IMM-BCP-01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Jun 2022to 6 Jan 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- 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 are eligible to participate.
- 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.
- Note: Other protocol defined Inclusion/Exclusion criteria apply
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Ark Clinical Research
Long Beach, California, 90806
Panax Clinical Research
Miami Lakes, Florida, 33014
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029
About this study
Official title: 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
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.
Read the 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
- Being tested
- IMM-BCP-01, Placebo
- Keywords
- IMM-BCP-01, antibody cocktail
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMM-BCP-01Drug
Single dose of IMM-BCP-01
PlaceboDrug
Placebo matching single dose of IMM-BCP-01
| Study group | Role | What they receive |
|---|---|---|
| IV Cohort 1 | Experimental | Single intravenous (IV) dose 1 of IMM-BCP-01 or matching placebo Receives: Drug: IMM-BCP-01; Drug: Placebo |
| IV Cohort 2 | Experimental | Single intravenous (IV) dose 2 of IMM-BCP-01 or matching placebo Receives: Drug: IMM-BCP-01; Drug: Placebo |
| IV Cohort 3 | Experimental | Single intravenous (IV) dose 1 of IMM-BCP-01 or matching placebo Receives: Drug: IMM-BCP-01; Drug: Placebo |
| IV Cohort 4 (optional) | Experimental | Single intravenous (IV) dose 4 of IMM-BCP-01 or matching placebo Receives: Drug: IMM-BCP-01; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of Treatment Emergent Adverse Events (TEAEs)
TEAEs include clinical laboratory values, standard 12-lead ECGs, vital signs, pulse oximetry
Measured: Up to 28 days
Secondary outcomes (10)
Incidence and severity of Treatment Emergent Adverse Events (TEAEs)
TEAEs include clinical laboratory values, standard 12-lead ECGs, vital signs, pulse oximetry
Measured: Up to 12 weeks
PK parameters
measured by maximum observed concentration
Measured: Up to 28 days
PK parameters
measured by time to maximum observed concentration
Measured: Up to 12 weeks
PK parameters
measured by terminal elimination half-life
Measured: Up to 12 weeks
PK parameters
measured by clearance
Measured: Up to 12 weeks
PK parameters
measured by volume of distribution
Measured: Up to 12 weeks
Anti drug antibody
change from baseline
Measured: Up to 28 days
Anti drug antibody
change from baseline
Measured: Up to 12 weeks
Viral clearance
change from baseline
Measured: Up to 28 days
Viral clearance
change from baseline
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start3 Jun 2022
- Primary completion6 Jan 2023
- Study completion6 Jan 2023
Why it stopped: Business decision to discontinue the study based on strategic prioritization.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Randomized, Double Blind, Dose Escalation
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immunome, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429021
- Sponsor's protocol ID
- IMM-BCP-1001
- Status last verified
- Sep 2024
- First submitted
- 15 Jun 2022
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05429021
- Acronym / sponsor ID
- IMM-BCP-1001
- Conditions
- SARS-CoV2 Infection, COVID-19
- Keywords
- IMM-BCP-01, antibody cocktail
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision to discontinue the study based on strategic prioritization.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Immunome, Inc.Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 6 Jan 2023 (actual)
- Study completion
- 6 Jan 2023 (actual)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Randomized, Double Blind, Dose Escalation
| Arm | Type | Receives |
|---|---|---|
| IV Cohort 1 | Experimental | Drug: IMM-BCP-01, Drug: PlaceboSingle intravenous (IV) dose 1 of IMM-BCP-01 or matching placebo |
| IV Cohort 2 | Experimental | Drug: IMM-BCP-01, Drug: PlaceboSingle intravenous (IV) dose 2 of IMM-BCP-01 or matching placebo |
| IV Cohort 3 | Experimental | Drug: IMM-BCP-01, Drug: PlaceboSingle intravenous (IV) dose 1 of IMM-BCP-01 or matching placebo |
| IV Cohort 4 (optional) | Experimental | Drug: IMM-BCP-01, Drug: PlaceboSingle intravenous (IV) dose 4 of IMM-BCP-01 or matching placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMM-BCP-01Single dose of IMM-BCP-01 | Drug | IV Cohort 1, IV Cohort 2, IV Cohort 3, IV Cohort 4 (optional) |
| PlaceboPlacebo matching single dose of IMM-BCP-01 | Drug | IV Cohort 1, IV Cohort 2, IV Cohort 3, IV Cohort 4 (optional) |
Primary outcome
Incidence and severity of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 28 days
TEAEs include clinical laboratory values, standard 12-lead ECGs, vital signs, pulse oximetry
10 secondary outcomes
Incidence and severity of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 12 weeks
PK parameters
Time frame: Up to 28 days
PK parameters
Time frame: Up to 12 weeks
PK parameters
Time frame: Up to 12 weeks
PK parameters
Time frame: Up to 12 weeks
PK parameters
Time frame: Up to 12 weeks
Anti drug antibody
Time frame: Up to 28 days
Anti drug antibody
Time frame: Up to 12 weeks
Viral clearance
Time frame: Up to 28 days
Viral clearance
Time frame: Up to 12 weeks
Results and safety
The study was stopped early (reason given: Business decision to discontinue the study based on strategic prioritization.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IMM-BCP-01 in people with SARS-CoV2 Infection and COVID-19, run by Immunome, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business decision to discontinue the study based on strategic prioritization.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of Treatment Emergent Adverse Events (TEAEs) (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.