Study to Evaluate IMG-004 in Healthy Participants

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

Conditions

• Healthy Participants

Interventions

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

Sponsors & Collaborators

• Inmagene LLC

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-08-08

Primary Completion

2024-05-02

Completion

2024-05-02

FDA Drug

Yes

Countries

• United States

Study Locations