Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAD IMG-004 · 1 trial · 1 indication
Incidence and severity of AEs, including clinically relevant findings from vital signs, physical examination, laboratory tests, and 12-lead ECG
| Arm | Type | Description |
|---|---|---|
| SAD cohort 1 active treatment | EXPERIMENTAL | 30mg |
| SAD cohort 2 active treatment | EXPERIMENTAL | 100mg. |
| SAD cohort 3 active treatment | EXPERIMENTAL | 200mg |
| SAD cohort 4 active treatment | EXPERIMENTAL | 400mg. |
| SAD cohort 5 active treatment | EXPERIMENTAL | 600mg. |
| SAD cohort 1 placebo | PLACEBO_COMPARATOR | 30mg |
| SAD cohort 2 placebo | PLACEBO_COMPARATOR | 100mg. |
| SAD cohort 3 placebo | PLACEBO_COMPARATOR | 200mg. |
| SAD cohort 4 placebo | PLACEBO_COMPARATOR | 400mg. |
| SAD cohort 5 placebo | PLACEBO_COMPARATOR | 600mg. |
| MAD cohort 1 active treatment | EXPERIMENTAL | 50mg |
| MAD cohort 1 placebo | PLACEBO_COMPARATOR | 50mg |
| MAD cohort 2 active treatment | EXPERIMENTAL | 150mg |
| MAD cohort 2 placebo | PLACEBO_COMPARATOR | 150mg |
| MAD cohort 3 active treatment | EXPERIMENTAL | 300mg |
| MAD cohort 3 placebo | PLACEBO_COMPARATOR | 300mg |
| Food Effect cohort | EXPERIMENTAL | 150mg |
| Name | Type | Description |
|---|---|---|
| SAD IMG-004 30mg | DRUG | Each participant will be randomized to receive a single oral dose of 30mg IMG-004 |
| SAD IMG-004 100mg | DRUG | Each participant will be randomized to receive a single oral dose of 100mg IMG-004 |
| SAD IMG-004 200mg | DRUG | Each participant will be randomized to receive a single oral dose of 200mg IMG-004 |
| SAD IMG-004 400mg | DRUG | Each participant will be randomized to receive a single oral dose of 400mg IMG-004 |
| SAD IMG-004 600mg | DRUG | Each participant will be randomized to receive a single oral dose of 600mg IMG-004 |
| SAD Placebo 30mg | DRUG | Each participant will be randomized to receive a single oral dose of 30mg matching placebo |
| SAD Placebo 100mg | DRUG | Each participant will be randomized to receive a single oral dose of 100mg matching placebo |
| SAD Placebo 200mg | DRUG | Each participant will be randomized to receive a single oral dose of 200mg matching placebo |
| SAD Placebo 400mg | DRUG | Each participant will be randomized to receive a single oral dose of 400mg matching placebo |
| SAD Placebo 600mg | DRUG | Each participant will be randomized to receive a single oral dose of 600mg matching placebo |
| MAD IMG-004 50mg | DRUG | Each participant will be randomized to receive daily oral dose of 50mg IMG-004 for 10 days |
| MAD Placebo 50mg | DRUG | Each participant will be randomized to receive daily oral dose of 50mg matching placebo for 10 days |
| MAD IMG-004 150mg | DRUG | Each participant will be randomized to receive daily oral dose of 150mg IMG-004 for 10 days |
| MAD Placebo 150mg | DRUG | Each participant will be randomized to receive daily oral dose of 150mg matching placebo for 10 days |
| MAD IMG-004 300mg | DRUG | Each participant will be randomized to receive daily oral dose of 300mg IMG-004 for 10 days |
| MAD Placebo 300mg | DRUG | Each participant will be randomized to receive daily oral dose of 300mg matching placebo for 10 days |
| FE IMG-004 150mg | DRUG | A single dose of IMG-004 at 150 mg dose level will be administered to the participants in fed and fasted states |
Inclusion Criteria: 1. Healthy adult males and/or females, 18 to 60 years of age (inclusive) at the date of signed consent form. 2. Body mass index (BMI) greater than or equal to 18.5 and less than 32 (kg/m2) and a minimum body weight of 45 kg. 3. Able to participate and comply with all study proce...
SAD IMG-004 is an investigational small molecule developed by ImageneBio, Inc. (ticker IMA). It has been studied in a single Phase 1 clinical trial in healthy adult participants in the United States. The specific disease indications for SAD IMG-004 have not been disclosed.
SAD IMG-004 is being developed by ImageneBio, Inc., which trades under the ticker IMA. The company sponsored the Phase 1 trial of the drug in healthy participants.
SAD IMG-004 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA.
SAD IMG-004 has been evaluated in one completed Phase 1 trial, NCT05349097, titled "Study to Evaluate IMG-004 in Healthy Participants." The trial enrolled 72 healthy adult volunteers in the United States and used a randomized, double-blind, placebo-controlled design.