A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of IMG-007 in Healthy Participants
Overview
- Phase
- Phase 1
- Intervention
- IMG-007 or placebo
- Conditions
- Healthy Participants
- Sponsor
- Inmagene LLC
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Incidence and severity of treatment-emergent adverse events (TEAEs)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
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.
Investigators
Eligibility Criteria
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)
Arms & Interventions
Cohort 5
Single dose of IMG or placebo solution, intravenously administered
Intervention: IMG-007 or placebo
Cohort 1
Single dose of IMG or placebo solution, intravenously administered
Intervention: IMG-007 or placebo
Cohort 2
Single dose of IMG or placebo solution, intravenously administered
Intervention: IMG-007 or placebo
Cohort 3
Single dose of IMG or placebo solution, intravenously administered
Intervention: IMG-007 or placebo
Cohort 4
Single dose of IMG or placebo solution, intravenously administered
Intervention: IMG-007 or placebo
Cohort 6
Single dose of IMG or placebo solution, intravenously administered
Intervention: IMG-007 or placebo
Cohort 7
Single dose of IMG or placebo solution, intravenously administered
Intervention: IMG-007 or placebo
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Incidence of anti-drug antibody (ADA) after infusion(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(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)(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;)