NCT05353972

Evaluate IMG-007 in Healthy Participants

A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of IMG-007 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Inmagene LLC · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is a double-blind, randomized, placebo-controlled, sequential ascending, single dose escalating (SAD) study to assess the safety and PK profile of IMG-007 in healthy participants. The study is comprised of 3 phases: screening phase, treatment phase, and safety follow-up phase.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	IMG-007 or placebo	intravenously administered

Timeline

• Start date: 2022-07-05
• Primary completion: 2023-05-31
• Completion: 2023-05-31
• First posted: 2022-04-29
• Last updated: 2023-06-28

Locations

1 site across 1 country: Australia