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

NCT ID: NCT06304740

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-06

Study Completion Date

2024-08-28

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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IMG-007 Cohort 1 (Healthy Participant)

Cohort 1 will receive a single subcutaneous dose of IMG-007 Dose 1 or matching placebo.

Group Type EXPERIMENTAL

IMG-007

Intervention Type DRUG

Subcutaneous injection of IMG-007

Placebo

Intervention Type DRUG

Subcutaneous Injection of Placebo

IMG-007 Cohort 2 (Healthy Participant)

Cohort 2 will receive a single subcutaneous dose of IMG-007 Dose 2 or matching placebo.

Group Type EXPERIMENTAL

IMG-007

Intervention Type DRUG

Subcutaneous injection of IMG-007

Placebo

Intervention Type DRUG

Subcutaneous Injection of Placebo

IMG-007 Cohort 3 (Healthy Participant)

Cohort 3 will receive a single subcutaneous dose of IMG-007 Dose 3 or matching placebo.

Group Type EXPERIMENTAL

IMG-007

Intervention Type DRUG

Subcutaneous injection of IMG-007

Placebo

Intervention Type DRUG

Subcutaneous Injection of Placebo

Interventions

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IMG-007

Subcutaneous injection of IMG-007

Intervention Type DRUG

Placebo

Subcutaneous Injection of Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Inmagene LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Linear Clinical Research

Perth, , Australia

Site Status

Countries

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Australia

Other Identifiers

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IMG-007-102

Identifier Type: -

Identifier Source: org_study_id