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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06304740
• Other study ID #: IMG-007-102
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 6, 2024
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: Inmagene LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• IMG-007
Subcutaneous injection of IMG-007
• Placebo
Subcutaneous Injection of Placebo

Locations

Country	Name	City	State
Australia	Linear Clinical Research	Perth

Sponsors (1)

Lead Sponsor	Collaborator
Inmagene LLC

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Event Evaluation	Incidence of adverse events emergent from a single subcutaneous dose of IMG-007 in healthy participants.	Up to 18 weeks
Secondary	Pharmacokinetic Parameters, Cmax	Peak serum concentration following the administration of a single subcutaneous dose of IMG-007	Up to 18 weeks
Secondary	Pharmacokinetic Parameters, Tmax	Time to peak serum concentration following the administration of a single subcutaneous dose of IMG-007	Up to 18 weeks
Secondary	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