Safety and Pharmacokinetics of Subcutaneous Dose of IMG-007 in Healthy Participants

A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of a Single Subcutaneous Dose of IMG-007 in Healthy Participants

This is a double-blind, randomized, placebo-controlled study to assess the safety and PK profile of a single subcutaneous dose of IMG-007 in healthy participants. The study will comprise of a 5-week screening period, a 3-day In-patient Period in a clinical research unit (CRU) and an Out-patient Follow-up Period up to 127 days. The study will include 3 dose cohorts which will be enrolled sequentially. Participants will receive a single subcutaneous dose of IMG-007 or placebo at Baseline according to their assigned dose.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: IMG-007; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Carina Freedman; Phone Number: 18583456927; Email: freedmanc@inmagenebio.com

Study Locations

• Australia
  • Perth, Australia
    • Recruiting
    • Linear Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

• Body mass index (BMI) greater than or equal to 18.0 kg/m2 and less than or equal to 32 kg/m2, and a minimum body weight of 50 kg for males and 45 kg for females
• Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study.
• Female participants who are not pregnant or breastfeeding and meet at least one of the following conditions: not of childbearing potential or of childbearing potential and agrees to use a highly effective method of contraception.
• Male participants who agree to practice true abstinence or agree to use highly effective methods of contraception with female partners of childbearing potentials or are surgically sterilized.

Exclusion Criteria:

• Conditions or laboratory abnormality that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study.
• Major surgery ≤ 4 weeks before the Baseline Visit or planned major surgical procedure during the study.
• Use of any prescription medication (except for hormonal contraceptives for female participants within the 14 days prior to the first dose.
• Drug or alcohol abuse.
• Use of more than 5 tobacco/nicotine-containing products per month within 3 months of the first dose.
• Hepatitis B, hepatitis C, or human immunodeficiency virus infection.
• Evidence of latent tuberculosis (TB) or a history of untreated or inadequately treated TB infection.
• Receipt of a live/live attenuated vaccine within 2 months prior to Baseline Visit.
• Hypersensitivity to study treatment or other biologics
• Participation in prior IMG-007 study or another research study involving an investigational product within 30 days (small molecule) or 3 months (biological product), or 5 half-lives (whichever is longer) prior to the Baseline (Day 1) Visit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IMG-007 Cohort 1 (Healthy Participant); Cohort 1 will receive a single subcutaneous dose of IMG-007 Dose 1 or matching placebo.	Drug: IMG-007; Subcutaneous injection of IMG-007; Drug: Placebo; Subcutaneous Injection of Placebo
Experimental: IMG-007 Cohort 2 (Healthy Participant); Cohort 2 will receive a single subcutaneous dose of IMG-007 Dose 2 or matching placebo.	Drug: IMG-007; Subcutaneous injection of IMG-007; Drug: Placebo; Subcutaneous Injection of Placebo
Experimental: IMG-007 Cohort 3 (Healthy Participant); Cohort 3 will receive a single subcutaneous dose of IMG-007 Dose 3 or matching placebo.	Drug: IMG-007; Subcutaneous injection of IMG-007; Drug: Placebo; Subcutaneous Injection of Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event Evaluation	Incidence of adverse events emergent from a single subcutaneous dose of IMG-007 in healthy participants.	Up to 18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic Parameters, Cmax	Peak serum concentration following the administration of a single subcutaneous dose of IMG-007	Up to 18 weeks
Pharmacokinetic Parameters, Tmax	Time to peak serum concentration following the administration of a single subcutaneous dose of IMG-007	Up to 18 weeks
Pharmacokinetic Parameters, AUC0-t	Area under the concentration-time curve from time 0 until the last observed concentration following the administration of a single subcutaneous dose of IMG-007	Up to 18 weeks

Collaborators and Investigators

• Sponsor: Inmagene LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: March 3, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IMG-007-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No