Evaluate IMG-007 in Healthy Participants

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.

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.