Approval Probability
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IW-3300 · 2 trials · 1 indication
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is lifethreatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; or other situations such as important medical events that may not be immediately life threatening or result in death or hospitalization but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. An SAE was considered a treatment-emergent SAE (serious TEAE) if the SAE started after initial study drug administration and within 1 day of the last dose of study drug.
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: 100 μg IW-3300 | EXPERIMENTAL | 100 μg dose of active drug (IW-3300) once daily for 7 days |
| Cohort 1: Placebo | PLACEBO_COMPARATOR | matching placebo once daily for 7 days |
| Cohort 2: 300 μg IW-3300 | EXPERIMENTAL | 300 μg dose of active drug (IW-3300) once daily for 7 days |
| Cohort 2: Placebo | PLACEBO_COMPARATOR | matching placebo once daily for 7 days |
| Cohort 3 (optional): Dose 3 | EXPERIMENTAL | Active drug (IW-3300) once daily for 7 days |
| Cohort 3 (optional): Placebo | PLACEBO_COMPARATOR | Matching placebo once daily for 7 days |
| Cohort 3: 900 μg IW-3300 | EXPERIMENTAL | Dose 3: within the cohort, 6 participants receive active drug (IW-3300) |
| Cohort 3: Placebo | PLACEBO_COMPARATOR | Within the cohort, 2 participants will receive the matching placebo dose |
| Cohort 4: 2500 μg IW-3300 | EXPERIMENTAL | Dose 4: within the cohort, 6 participants receive active drug (IW-3300) |
| Cohort 4: Placebo | PLACEBO_COMPARATOR | Within the cohort, 2 participants will receive the matching placebo dose |
| Name | Type | Description |
|---|---|---|
| IW-3300 | DRUG | A dose of IW-3300 administered rectally (as a low-volume \[20 mL\] enema). |
| Placebo | DRUG | A dose of placebo administered rectally (as a low-volume \[20 mL\] enema). |
Inclusion Criteria: * Males and female subjects of non-childbearing potential * Ages 18 to 60 years * Medically healthy with no clinically significant findings during medical evaluation including physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory tests. * Body mass index...
IW-3300 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with trials evaluating single and multiple ascending doses to assess its safety and tolerability. It is not approved for any indication.
IW-3300 is being developed by Ironwood Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol IRWD. The company is conducting Phase 1 clinical trials of IW-3300 in the United States.
IW-3300 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.
IW-3300 has two completed Phase 1 trials. NCT05188261 studied single ascending doses in 32 healthy volunteers, and NCT05362695 studied multiple ascending doses in 18 healthy subjects. Both trials were conducted in the United States and were randomized, double-blind, and placebo-controlled.
No alternative names for IW-3300 have been disclosed. It is identified solely by its investigational code name IW-3300 in clinical trial records.