NCT05349097

Study to Evaluate IMG-004 in Healthy Participants

A Phase 1, Randomized, Double-blind, Placebo-controlled Study of Orally Administered IMG-004 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Dose(s) and an Open-Label Study of Single Oral Dose of IMG-004 to Evaluate the Food Effect in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Inmagene LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

A Phase 1, Randomized, Double-blind, Placebo-controlled Study of Orally Administered IMG-004 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Dose(s) and an Open-Label Study of Single Oral Dose of IMG-004 to Evaluate the Food Effect in Healthy Participants

Detailed description

The study is a Phase 1, randomized, double-blind, placebo-controlled study of orally administered IMG-004 to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses in healthy participants, in which 8 dosing cohort levels are planned to be evaluated. Food Effect of IMG-004 will also be evaluated in single oral dose of IMG-004 in healthy participants

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	SAD IMG-004 30mg	Each participant will be randomized to receive a single oral dose of 30mg IMG-004
DRUG	SAD IMG-004 100mg	Each participant will be randomized to receive a single oral dose of 100mg IMG-004
DRUG	SAD IMG-004 200mg	Each participant will be randomized to receive a single oral dose of 200mg IMG-004
DRUG	SAD IMG-004 400mg	Each participant will be randomized to receive a single oral dose of 400mg IMG-004
DRUG	SAD IMG-004 600mg	Each participant will be randomized to receive a single oral dose of 600mg IMG-004
DRUG	SAD Placebo 30mg	Each participant will be randomized to receive a single oral dose of 30mg matching placebo
DRUG	SAD Placebo 100mg	Each participant will be randomized to receive a single oral dose of 100mg matching placebo
DRUG	SAD Placebo 200mg	Each participant will be randomized to receive a single oral dose of 200mg matching placebo
DRUG	SAD Placebo 400mg	Each participant will be randomized to receive a single oral dose of 400mg matching placebo
DRUG	SAD Placebo 600mg	Each participant will be randomized to receive a single oral dose of 600mg matching placebo
DRUG	MAD IMG-004 50mg	Each participant will be randomized to receive daily oral dose of 50mg IMG-004 for 10 days
DRUG	MAD Placebo 50mg	Each participant will be randomized to receive daily oral dose of 50mg matching placebo for 10 days
DRUG	MAD IMG-004 150mg	Each participant will be randomized to receive daily oral dose of 150mg IMG-004 for 10 days
DRUG	MAD Placebo 150mg	Each participant will be randomized to receive daily oral dose of 150mg matching placebo for 10 days
DRUG	MAD IMG-004 300mg	Each participant will be randomized to receive daily oral dose of 300mg IMG-004 for 10 days
DRUG	MAD Placebo 300mg	Each participant will be randomized to receive daily oral dose of 300mg matching placebo for 10 days
DRUG	FE IMG-004 150mg	A single dose of IMG-004 at 150 mg dose level will be administered to the participants in fed and fasted states

Timeline

• Start date: 2022-08-08
• Primary completion: 2024-05-02
• Completion: 2024-05-02
• First posted: 2022-04-27
• Last updated: 2024-05-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study