Evaluate IMG-007 in Healthy Participants

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05353972
• Other study ID #: IMG-007-101
• Status: Completed
• Phase: Phase 1
• Start date: July 5, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: June 2023
• Source: Inmagene LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• IMG-007 or placebo
intravenously administered

Locations

Country	Name	City	State
Australia	Linear Clinical Research	Nedlands	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
Inmagene LLC

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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;
Secondary	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;
Secondary	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;
Secondary	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;
Secondary	Half-life t½	Half-life t½	Cohort 1 to 5: up to 85 days; Cohort 6 to 7: up to 127 days;
Secondary	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;