Evaluate IMG-007 in Healthy Participants

NCT05353972 | Completed Phase 1

• 1 other identifier: IMG-007-101
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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;

• 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;

Study Arms (7)

Cohort 1

EXPERIMENTAL

Single dose of IMG or placebo solution, intravenously administered

Drug: IMG-007 or placebo

Cohort 2

EXPERIMENTAL

Single dose of IMG or placebo solution, intravenously administered

Drug: IMG-007 or placebo

Cohort 3

EXPERIMENTAL

Single dose of IMG or placebo solution, intravenously administered

Drug: IMG-007 or placebo

Cohort 4

EXPERIMENTAL

Single dose of IMG or placebo solution, intravenously administered

Drug: IMG-007 or placebo

Cohort 5

EXPERIMENTAL

Single dose of IMG or placebo solution, intravenously administered

Drug: IMG-007 or placebo

Cohort 6

EXPERIMENTAL

Single dose of IMG or placebo solution, intravenously administered

Drug: IMG-007 or placebo

Cohort 7

EXPERIMENTAL

Single dose of IMG or placebo solution, intravenously administered

Drug: IMG-007 or placebo

Interventions

IMG-007 or placebo DRUG

intravenously administered

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Inmagene LLC: lead

Study Sites (1)

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

Location

Study Officials

• Peter Schrader

  Linear

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 29, 2022
• Study Start: July 5, 2022
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: June 28, 2023

Record last verified: 2023-06

Locations

AU (1)