Evaluate IMG-007 in Healthy Participants

June 27, 2023 updated by: Inmagene LLC

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Linear Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Participants aged between 18 to 50 years (inclusive)
  2. 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.
  3. Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study.

Exclusion Criteria:

  1. History of disease of the central nervous system, cardiovascular system, kidney, liver, digestive system, respiratory system, or metabolic/endocrine system
  2. History of immunological abnormality
  3. History of severe immediate hypersensitivity reaction to OX40 antagonists or other monoclonal antibodies
  4. History of anaphylaxis or significant reactions to foods, medications, or other allergens
  5. Major surgery ≤4 weeks before Baseline visit.
  6. History of malignancy or known current malignancy,
  7. Participant has an active infection or history of infections
  8. 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.
  9. History of asthma
  10. Having evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
  11. Participants with positive testing for COVID-19 at the Baseline visit.
  12. Participants with clinically significantly abnormal laboratory values, as determined by the Investigator or medically qualified designee, i
  13. Clinically significant abnormal findings at Screening or Baseline visits
  14. Systolic blood pressure below 100 mmHg, at any time points prior to IMP administration
  15. Use of any prescription medication
  16. Use of over-the-counter medication
  17. History of, or current substance abuse considered significant
  18. Use of more than 5 tobacco/nicotine-containing products
  19. Average alcohol consumption of more than 14 units/week for females and 21 units/week for males
  20. Receipt of an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) prior to Day 1 dosing.
  21. Live (attenuated) vaccination within 8 weeks before Screening or plan to be vaccinated by live (attenuated) vaccine during the trial
  22. 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.
  23. 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.
  24. Pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1
Single dose of IMG or placebo solution, intravenously administered
Drug: IMG-007 or placebo
intravenously administered
Experimental: Cohort 2
Single dose of IMG or placebo solution, intravenously administered
Drug: IMG-007 or placebo
intravenously administered
Experimental: Cohort 3
Single dose of IMG or placebo solution, intravenously administered
Drug: IMG-007 or placebo
intravenously administered
Experimental: Cohort 4
Single dose of IMG or placebo solution, intravenously administered
Drug: IMG-007 or placebo
intravenously administered
Experimental: Cohort 5
Single dose of IMG or placebo solution, intravenously administered
Drug: IMG-007 or placebo
intravenously administered
Experimental: Cohort 6
Single dose of IMG or placebo solution, intravenously administered
Drug: IMG-007 or placebo
intravenously administered
Experimental: Cohort 7
Single dose of IMG or placebo solution, intravenously administered
Drug: IMG-007 or placebo
intravenously administered

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum observed concentration (Cmax) after infusion
Time Frame: Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;
Maximum observed concentration (Cmax) after infusion
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;
Time at which Cmax is observed after infusion (tmax)
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 last observation (AUC 0-t)
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;
Area under the concentration time curve from time 0 to infinity (AUC0-inf)
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;
Half-life t½
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;
Incidence of anti-drug antibody (ADA) after infusion
Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inmagene LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter Schrader, Linear

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 5, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IMG-007-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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