Evaluate IMG-007 in Healthy Participants

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of IMG-007 in Healthy Participants

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: IMG-007 or placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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, 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Single dose of IMG or placebo solution, intravenously administered | Drug: IMG-007 or placebo<br>* intravenously administered<br>|
| Experimental: Cohort 2<br>Single dose of IMG or placebo solution, intravenously administered | Drug: IMG-007 or placebo<br>* intravenously administered<br>|
| Experimental: Cohort 3<br>Single dose of IMG or placebo solution, intravenously administered | Drug: IMG-007 or placebo<br>* intravenously administered<br>|
| Experimental: Cohort 4<br>Single dose of IMG or placebo solution, intravenously administered | Drug: IMG-007 or placebo<br>* intravenously administered<br>|
| Experimental: Cohort 5<br>Single dose of IMG or placebo solution, intravenously administered | Drug: IMG-007 or placebo<br>* intravenously administered<br>|
| Experimental: Cohort 6<br>Single dose of IMG or placebo solution, intravenously administered | Drug: IMG-007 or placebo<br>* intravenously administered<br>|
| Experimental: Cohort 7<br>Single dose of IMG or placebo solution, intravenously administered | Drug: IMG-007 or placebo<br>* intravenously administered<br>|

What is the study measuring?
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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; |