NCT06304740

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Inmagene LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	IMG-007	Subcutaneous injection of IMG-007
DRUG	Placebo	Subcutaneous Injection of Placebo

Timeline

• Start date: 2024-03-06
• Primary completion: 2024-08-28
• Completion: 2024-08-28
• First posted: 2024-03-12
• Last updated: 2024-12-12

Locations

1 site across 1 country: Australia