Evaluate IMG-007 in Healthy Participants

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: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: IMG-007 or placebo

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: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Nicki Tieken; Phone Number: 817-863-5065; Email: Tiekenn@inmagenebio.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Incidence and severity of treatment-emergent adverse events (TEAEs)	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

Outcome Measure	Measure Description	Time Frame
Maximum observed concentration (Cmax) after infusion	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 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)	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)	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	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	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

• Sponsor: Inmagene LLC
• Investigators: Principal Investigator: Peter Schrader, Linear

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2022
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: April 25, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID 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