Evaluate IMG-007 in Healthy Participants
Phase 1
Completed
- Conditions
- Healthy Participants
- Interventions
- Drug: IMG-007 or placebo
- Registration Number
- NCT05353972
- Lead Sponsor
- Inmagene LLC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 IMG-007 or placebo Single dose of IMG or placebo solution, intravenously administered Cohort 2 IMG-007 or placebo Single dose of IMG or placebo solution, intravenously administered Cohort 3 IMG-007 or placebo Single dose of IMG or placebo solution, intravenously administered Cohort 4 IMG-007 or placebo Single dose of IMG or placebo solution, intravenously administered Cohort 5 IMG-007 or placebo Single dose of IMG or placebo solution, intravenously administered Cohort 6 IMG-007 or placebo Single dose of IMG or placebo solution, intravenously administered Cohort 7 IMG-007 or placebo Single dose of IMG or placebo solution, intravenously administered
- Primary Outcome Measures
Name Time Method 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; Incidence and severity of treatment-emergent adverse events (TEAEs)
- Secondary Outcome Measures
Name Time Method Incidence of anti-drug antibody (ADA) after infusion Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days; Incidence of anti-drug antibody (ADA) after infusion
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; Area under the concentration time curve from time 0 to infinity (AUC0-inf)
Half-life t½ Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days; Half-life t½
Maximum observed concentration (Cmax) after infusion Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days; Maximum observed concentration (Cmax) after infusion
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; Time at which Cmax is observed after infusion (tmax)
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 last observation (AUC 0-t)
Trial Locations
- Locations (1)
Linear Clinical Research
🇦🇺Nedlands, Western Australia, Australia