Healthy ParticipantsPhase 1NCT05353972
Evaluate IMG-007 in Healthy Participants
A Phase 1 study of Healthy Participants, run by Inmagene LLC at 1 site in Australia.
Trial summary
This first in human (FIH) study will evaluate the safety, tolerability, pharmacokinetics (PK)), and immunogenicity of a single ascending dose of IMG-007 in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteAustralia
- Study dates
- 5 Jul 2022to 31 May 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants aged between 18 to 50 years (inclusive)
- Body mass index (BMI) greater than or equal to 18.0 kg/m2 and less than 32 kg/m2 and a minimum body weight of 50 kg for males and 45 kg for females at both the Screening and Baseline visits.
- Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study.
Who cannot join
- History of disease of the central nervous system, cardiovascular system, kidney, liver, digestive system, respiratory system, or metabolic/endocrine system
- History of immunological abnormality
- History of severe immediate hypersensitivity reaction to OX40 antagonists or other monoclonal antibodies
- History of anaphylaxis or significant reactions to foods, medications, or other allergens
- Major surgery ≤4 weeks before Baseline visit.
- History of malignancy or known current malignancy,
Show all 24Show fewer
- Participant has an active infection or history of infections
- Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or antibody to Hepatitis B core antigen (HBcAb) with positive test for HBV DNA (>500 IU/ml) or hepatitis C antibodies (HCV) at Screening visit.
- History of asthma
- Having evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
- Participants with positive testing for COVID-19 at the Baseline visit.
- Participants with clinically significantly abnormal laboratory values, as determined by the Investigator or medically qualified designee, i
- Clinically significant abnormal findings at Screening or Baseline visits
- Systolic blood pressure below 100 mmHg, at any time points prior to IMP administration
- Use of any prescription medication
- Use of over-the-counter medication
- History of, or current substance abuse considered significant
- Use of more than 5 tobacco/nicotine-containing products
- Average alcohol consumption of more than 14 units/week for females and 21 units/week for males
- Receipt of an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) prior to Day 1 dosing.
- Live (attenuated) vaccination within 8 weeks before Screening or plan to be vaccinated by live (attenuated) vaccine during the trial
- COVID-19 vaccination, or influenza vaccination(inactivated), within 14 days prior or planning to receive COVID-19 vaccination or influenza vaccination(inactivated) within 14 days post IMP administration.
- Donated or lost more than 500 mL of blood or plasma within 3 months of Screening or received blood products within 8 weeks of Screening.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of IMG-007 in Healthy Participants
This first in human (FIH) study will evaluate the safety, tolerability, pharmacokinetics (PK)), and immunogenicity of a single ascending dose of IMG-007 in healthy participants.
Read the detailed description
This study is a double-blind, randomized, placebo-controlled, sequential ascending, single dose escalating (SAD) study to assess the safety and PK profile of IMG-007 in healthy participants. The study is comprised of 3 phases: screening phase, treatment phase, and safety follow-up phase.
- Conditions
- Healthy Participants
- Being tested
- IMG-007 or placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMG-007 or placeboDrug
intravenously administered
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Single dose of IMG or placebo solution, intravenously administered Receives: Drug: IMG-007 or placebo |
| Cohort 2 | Experimental | Single dose of IMG or placebo solution, intravenously administered Receives: Drug: IMG-007 or placebo |
| Cohort 3 | Experimental | Single dose of IMG or placebo solution, intravenously administered Receives: Drug: IMG-007 or placebo |
| Cohort 4 | Experimental | Single dose of IMG or placebo solution, intravenously administered Receives: Drug: IMG-007 or placebo |
| Cohort 5 | Experimental | Single dose of IMG or placebo solution, intravenously administered Receives: Drug: IMG-007 or placebo |
| Cohort 6 | Experimental | Single dose of IMG or placebo solution, intravenously administered Receives: Drug: IMG-007 or placebo |
| Cohort 7 | Experimental | Single dose of IMG or placebo solution, intravenously administered Receives: Drug: IMG-007 or 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)
Incidence and severity of treatment-emergent adverse events (TEAEs)
Measured: Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;
Secondary outcomes (6)
Maximum observed concentration (Cmax) after infusion
Maximum observed concentration (Cmax) after infusion
Measured: Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;
Time at which Cmax is observed after infusion (tmax)
Time at which Cmax is observed after infusion (tmax)
Measured: Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;
Area under the concentration time curve from time 0 to last observation (AUC 0-t)
Area under the concentration time curve from time 0 to last observation (AUC 0-t)
Measured: Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;
Area under the concentration time curve from time 0 to infinity (AUC0-inf)
Area under the concentration time curve from time 0 to infinity (AUC0-inf)
Measured: Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;
Half-life t½
Half-life t½
Measured: Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;
Incidence of anti-drug antibody (ADA) after infusion
Incidence of anti-drug antibody (ADA) after infusion
Measured: Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start5 Jul 2022
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inmagene LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Schrader, Principal investigator, Linear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353972
- Sponsor's protocol ID
- IMG-007-101
- Status last verified
- Jun 2023
- First submitted
- 18 Apr 2022
- Last updated
- 28 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of IMG-007 in Healthy Participants
- ClinicalTrials.gov ID
- NCT05353972
- Acronym / sponsor ID
- IMG-007-101
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Inmagene LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 29 Apr 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 first in human (FIH) study will evaluate the safety, tolerability, pharmacokinetics (PK)), and immunogenicity of a single ascending dose of IMG-007 in healthy participants.
Detailed description
This study is a double-blind, randomized, placebo-controlled, sequential ascending, single dose escalating (SAD) study to assess the safety and PK profile of IMG-007 in healthy participants. The study is comprised of 3 phases: screening phase, treatment phase, and safety follow-up phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: IMG-007 or placeboSingle dose of IMG or placebo solution, intravenously administered |
| Cohort 2 | Experimental | Drug: IMG-007 or placeboSingle dose of IMG or placebo solution, intravenously administered |
| Cohort 3 | Experimental | Drug: IMG-007 or placeboSingle dose of IMG or placebo solution, intravenously administered |
| Cohort 4 | Experimental | Drug: IMG-007 or placeboSingle dose of IMG or placebo solution, intravenously administered |
| Cohort 5 | Experimental | Drug: IMG-007 or placeboSingle dose of IMG or placebo solution, intravenously administered |
| Cohort 6 | Experimental | Drug: IMG-007 or placeboSingle dose of IMG or placebo solution, intravenously administered |
| Cohort 7 | Experimental | Drug: IMG-007 or placeboSingle dose of IMG or placebo solution, intravenously administered |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants aged between 18 to 50 years (inclusive)
- Body mass index (BMI) greater than or equal to 18.0 kg/m2 and less than 32 kg/m2 and a minimum body weight of 50 kg for males and 45 kg for females at both the Screening and Baseline visits.
- Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study.
Key exclusion criteria (24 listed)
- History of disease of the central nervous system, cardiovascular system, kidney, liver, digestive system, respiratory system, or metabolic/endocrine system
- History of immunological abnormality
- History of severe immediate hypersensitivity reaction to OX40 antagonists or other monoclonal antibodies
- History of anaphylaxis or significant reactions to foods, medications, or other allergens
- Major surgery ≤4 weeks before Baseline visit.
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 |
|---|---|---|
| IMG-007 or placebointravenously administered | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7 |
Primary outcome
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame: Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;
Incidence and severity of treatment-emergent adverse events (TEAEs)
6 secondary outcomes
Maximum observed concentration (Cmax) after infusion
Time frame: Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;
Time at which Cmax is observed after infusion (tmax)
Time frame: Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;
Area under the concentration time curve from time 0 to last observation (AUC 0-t)
Time frame: Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;
Area under the concentration time curve from time 0 to infinity (AUC0-inf)
Time frame: Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;
Half-life t½
Time frame: Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;
Incidence of anti-drug antibody (ADA) after infusion
Time frame: Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
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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.
Peter Schrader principal investigator
Linear
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 of Healthy Participants, run by Inmagene LLC at 1 site in Australia.
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 3 inclusion and 24 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: finished, as of the sponsor's last update on 28 Jun 2023. 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 Australia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 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 28 Jun 2023.