Healthy VolunteersPhase 1NCT05184218
Evaluation of IGM-6268 in Healthy Adults and Patients With Mild to Moderate COVID-19
A Phase 1 study testing IGM-6268 in people with Healthy Volunteers and COVID-19, run by IGM Biosciences, Inc. at 1 site in South Africa.
Trial summary
This is a Phase 1, multi-center, randomized, double-blinded, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics (PK) of IGM-6268 administered intranasally and intraorally in healthy volunteers and in outpatients with mild-moderate COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, COVID-19
- What is being tested?
- IGM-6268
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteSouth Africa
- Study dates
- 20 Jan 2022to 4 Jul 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is male or non-pregnant female adult ≥ 18 and ≤ 55 years of age
- Has a body mass index (BMI) < 35 kg/m2.
- Is healthy as determined by medical history and physical examination
- Agrees to use contraception through 3 months after the last dose of IGM-6268
- Is male or non-pregnant female adult ≥ 18 and ≤ 55 years of age
- Agrees to use contraception through 3 months after the last dose of IGM-6268
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- Agrees to the collection of blood, urine, saliva, and nasopharyngeal samples, per protocol.
- Signs and symptoms of mild to moderate COVID-19 but not requiring hospitalization
- Has a laboratory-confirmed SARS-CoV-2 infection as determined by FDA-authorized antigen or NAAT diagnostic assay during the period of 72 hours prior to enrollment.
Who cannot join
- Receipt of any COVID-19 vaccine during this study and follow-up period
- Prior positive SARS-CoV2 test
- Hepatitis B virus (HBV), hepatitis C virus (HCV), or uncontrolled human immunodeficiency virus (HIV) infection
- Use of any nasally administered drug
- Mild-Moderate COVID Patients
- Receipt of any COVID-19 vaccine during this study and follow-up period
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- Receipt of remdisivir, antiviral antibody treatment (plasma or Mabs), immosuppressive therapies, or cytokine-targeted anti-inflammatory drugs
- Concurrent use of drugs not approved for use in COVID-19 patients (e.g., ivermectin, chloroquine/hydroxychloroquine, budesonide).
- Co-morbidities including but not limited to hypertension, cardiovascular disease, diabetes (Type 1 or 2), chronic kidney disease, or asthma
- Subject is considered to be in their last few weeks of life prior to this acute illness
- Cancer within the last 5 years except stable prostate cancer and basal cell carcinoma
- Hepatitis B virus (HBV), hepatitis C virus (HCV), or uncontrolled human immunodeficiency virus (HIV) infection
- Influenza or confirmed or suspected pulmonary or systemic bacterial infection
- Receipt of any COVID-19 vaccine during this study and follow-up period
- Use of any nasally administered drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Intranasal Plus Intraoral IGM-6268 in Healthy Adults and Patients With Mild to Moderate COVID-19
This is a Phase 1, multi-center, randomized, double-blinded, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics (PK) of IGM-6268 administered intranasally and intraorally in healthy volunteers and in outpatients with mild-moderate COVID-19. IGM-6268 or placebo will be administered by intranasal + intraoral spray using a Teleflex Mucosal Atomization Device Nasal™ Intranasal Mucosal Atomization Device once, or once or twice each day for 5 days.
Read the detailed description
IGM-6268 is an engineered Immunoglobulin M (IgM) antibody that specifically targets the receptor binding domain (RBD) of the SARS-CoV-2 spike protein. This humanized pentameric IgM antibody has 10 binding sites to the spike protein and a J-chain to enable the formation of IgM pentamers.
IGM-6268 is being developed as a treatment for or prophylaxis of symptoms associated with mild to moderate COVID-19. The primary mechanism of action of IGM-6268 is to block the binding of the SARS-CoV-2 RBD on the spike protein to human angiotensin converting enzyme 2 (hACE2), the cellular receptor for SARS-CoV-2. By blocking this binding, IGM 6268 neutralizes the infectivity of the virus.
- Conditions
- Healthy Volunteers, COVID-19
- Being tested
- IGM-6268, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGM-6268Drug
Active Comparator
PlaceboDrug
Placebo Comparator
| Study group | Role | What they receive |
|---|---|---|
| Sentinel | Experimental | In the Sentinel Cohort, healthy volunteers will be randomized to receive intranasal and intraoral administration of 1 mg of IGM 6268 or placebo once per day for 5 days. Receives: Drug: IGM-6268; Drug: Placebo |
| Cohort 1 | Experimental | In Cohort 1, healthy volunteers will be randomized to receive intranasal and intraoral administration of 3.75 mg of IGM 6268 or placebo once per day for 5 days. Receives: Drug: IGM-6268; Drug: Placebo |
| Cohort 2 | Experimental | In Cohort 2, healthy volunteers will be randomized to receive intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo once per day for 5 days. Receives: Drug: IGM-6268; Drug: Placebo |
| Cohort 3 | Experimental | In Cohort 3, healthy volunteers will be randomized to receive intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo twice per day for 5 days. Receives: Drug: IGM-6268; Drug: Placebo |
| Cohort 4 | Experimental | In Cohort 4, mild-moderate Covid patients will be randomized to receive intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo once per day for 5 days. Receives: Drug: IGM-6268; Drug: Placebo |
| Cohort 5 | Experimental | In Cohort 5, mild-moderate Covid patients will be randomized to receive one intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo twice per day for 5 days. Receives: Drug: IGM-6268; Drug: Placebo |
| Ph1b Expansion | Experimental | In the Ph1b expansion cohort, mild-moderate Covid patients will be randomized to receive one intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo once or twice per day for 5 days. This cohort may be opened per Sponsor's discretion based on initial safety and activity. Receives: Drug: IGM-6268; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety & tolerability of IGM-6268 by assessing the number, severity, and type of adverse events per CTCAE 5.0
Measured: Through 60 days following receipt of final dose
Secondary outcomes (2)
Concentration of IGM-6268 in serum
Measured: Predose through Day 6 (healthy volunteers) or Day 5 (mild-moderate COVID patients)
Incidence of anti-IGM-6268 antibodies in serum
Measured: Prior to dosing and at Day 28 following receipt of initial dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start20 Jan 2022
- Primary completion6 May 2022
- Study completion4 Jul 2022
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Subjects will be randomized to receive intranasal and intraoral administration of IGM-6268 or placebo at the assigned doses. Cohorts will be enrolled sequentially. Cohorts 1-3 and Sentinel will enroll healthy volunteers and Cohorts 4-5 and Ph1b Expansion will enroll mild-moderate COVID-19 patients.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- IGM Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roel Funke, Study director, IGM Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184218
- Sponsor's protocol ID
- IGM-6268-002
- Status last verified
- Oct 2022
- First submitted
- 6 Jan 2022
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Intranasal Plus Intraoral IGM-6268 in Healthy Adults and Patients With Mild to Moderate COVID-19
- ClinicalTrials.gov ID
- NCT05184218
- Acronym / sponsor ID
- IGM-6268-002
- Conditions
- Healthy Volunteers, COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 26 participants (actual)
- Lead sponsor
- IGM Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 6 May 2022 (actual)
- Study completion
- 4 Jul 2022 (actual)
- First posted
- 11 Jan 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.
This is a Phase 1, multi-center, randomized, double-blinded, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics (PK) of IGM-6268 administered intranasally and intraorally in healthy volunteers and in outpatients with mild-moderate COVID-19. IGM-6268 or placebo will be administered by intranasal + intraoral spray using a Teleflex Mucosal Atomization Device Nasal™ Intranasal Mucosal Atomization Device once, or once or twice each day for 5 days.
Detailed description
IGM-6268 is an engineered Immunoglobulin M (IgM) antibody that specifically targets the receptor binding domain (RBD) of the SARS-CoV-2 spike protein. This humanized pentameric IgM antibody has 10 binding sites to the spike protein and a J-chain to enable the formation of IgM pentamers.
IGM-6268 is being developed as a treatment for or prophylaxis of symptoms associated with mild to moderate COVID-19. The primary mechanism of action of IGM-6268 is to block the binding of the SARS-CoV-2 RBD on the spike protein to human angiotensin converting enzyme 2 (hACE2), the cellular receptor for SARS-CoV-2. By blocking this binding, IGM 6268 neutralizes the infectivity of the virus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
- Model description
- Subjects will be randomized to receive intranasal and intraoral administration of IGM-6268 or placebo at the assigned doses. Cohorts will be enrolled sequentially. Cohorts 1-3 and Sentinel will enroll healthy volunteers and Cohorts 4-5 and Ph1b Expansion will enroll mild-moderate COVID-19 patients.
| Arm | Type | Receives |
|---|---|---|
| Sentinel | Experimental | Drug: IGM-6268, Drug: PlaceboIn the Sentinel Cohort, healthy volunteers will be randomized to receive intranasal and intraoral administration of 1 mg of IGM 6268 or placebo once per day for 5 days. |
| Cohort 1 | Experimental | Drug: IGM-6268, Drug: PlaceboIn Cohort 1, healthy volunteers will be randomized to receive intranasal and intraoral administration of 3.75 mg of IGM 6268 or placebo once per day for 5 days. |
| Cohort 2 | Experimental | Drug: IGM-6268, Drug: PlaceboIn Cohort 2, healthy volunteers will be randomized to receive intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo once per day for 5 days. |
| Cohort 3 | Experimental | Drug: IGM-6268, Drug: PlaceboIn Cohort 3, healthy volunteers will be randomized to receive intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo twice per day for 5 days. |
| Cohort 4 | Experimental | Drug: IGM-6268, Drug: PlaceboIn Cohort 4, mild-moderate Covid patients will be randomized to receive intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo once per day for 5 days. |
| Cohort 5 | Experimental | Drug: IGM-6268, Drug: PlaceboIn Cohort 5, mild-moderate Covid patients will be randomized to receive one intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo twice per day for 5 days. |
| Ph1b Expansion | Experimental | Drug: IGM-6268, Drug: PlaceboIn the Ph1b expansion cohort, mild-moderate Covid patients will be randomized to receive one intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo once or twice per day for 5 days. This cohort may be opened per Sponsor's discretion based on initial safety and activity. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Is male or non-pregnant female adult ≥ 18 and ≤ 55 years of age
- Has a body mass index (BMI) < 35 kg/m2.
- Is healthy as determined by medical history and physical examination
- Agrees to use contraception through 3 months after the last dose of IGM-6268
- Is male or non-pregnant female adult ≥ 18 and ≤ 55 years of age
Key exclusion criteria (15 listed)
- Receipt of any COVID-19 vaccine during this study and follow-up period
- Prior positive SARS-CoV2 test
- Hepatitis B virus (HBV), hepatitis C virus (HCV), or uncontrolled human immunodeficiency virus (HIV) infection
- Use of any nasally administered drug
- Mild-Moderate COVID Patients
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 |
|---|---|---|
| IGM-6268Active Comparator | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Ph1b Expansion, Sentinel |
| PlaceboPlacebo Comparator | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Ph1b Expansion, Sentinel |
Primary outcome
Safety & tolerability of IGM-6268 by assessing the number, severity, and type of adverse events per CTCAE 5.0
Time frame: Through 60 days following receipt of final dose
2 secondary outcomes
Concentration of IGM-6268 in serum
Time frame: Predose through Day 6 (healthy volunteers) or Day 5 (mild-moderate COVID patients)
Incidence of anti-IGM-6268 antibodies in serum
Time frame: Prior to dosing and at Day 28 following receipt of initial dose
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
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Screening Protocol
Pain
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.
Roel Funke study director
IGM Biosciences, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IGM-6268 in people with Healthy Volunteers and COVID-19, run by IGM Biosciences, Inc. at 1 site in South Africa.
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 9 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 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. 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: Sponsor Decision). 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?
Safety & tolerability of IGM-6268 by assessing the number, severity, and type of adverse events per CTCAE 5.0 (time frame: Through 60 days following receipt of final dose). 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 14 Oct 2022.