Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SDI-118 · 1 trial · 1 indication
Adverse events (AEs) will be coded using medical dictionary for regulatory activities (MedDRA). An AE is any untoward medical occurrence in a participant administered a study drug and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical product whether or not considered related to the medical product. An AE is considered "serious" if, in the view of either the investigator or sponsor, the event: results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires hospitalization or prolongation to hospitalization, or other medically important event.
Number of participants with potentially clinically significant laboratory values (hematology/chemistry/urinalysis)
Number of participants with potentially clinically significant vital sign values
Number of participants with potentially clinically significant temperature values
Number of participants with potentially clinically significant ECG values.
Number of participants with potentially clinically significant changes in physical examination.
Number of participants with potentially clinically significant changes in neurological examination.
Number of participants with potentially clinically significant changes in Profile of Mood States (Brief) values.
Number of participants with potentially clinically significant changes in Bond-Lader VAS values.
| Arm | Type | Description |
|---|---|---|
| SDI-118 Dose 1 | EXPERIMENTAL | - |
| SDI-118 Dose 2 | EXPERIMENTAL | - |
| SDI-118 Dose 3 | EXPERIMENTAL | - |
| SDI-118 Dose 4 | EXPERIMENTAL | - |
| SDI-118 Dose 5 | EXPERIMENTAL | - |
| SDI-118 Dose 6 | EXPERIMENTAL | - |
| SDI-118 Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| SDI-118 | DRUG | SDI-118 Powder in Capsule |
| Placebo | DRUG | Matching Placebo |
Inclusion Criteria: * Healthy male subjects, 18 to 50 years of age, inclusive. * Non-smokers or abstinence from tobacco for at least 3 months prior to screening. * Body mass index (BMI) between 18 and 30 kg/m2, inclusive, with a minimum weight of 50 kg and maximum of 100 kg. * Venous access suffici...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Alto Neuroscience, Inc. | ANRO | 1 | PHASE2 | ALTO-101 |
| Eli Lilly and Company | LLY | 2 | - | Undisclosed |
| Rhythm Pharmaceuticals, Inc. | RYTM | 1 | - | Undisclosed |
SDI-118 is an investigational small molecule being developed for cognitive disorders. It is currently in Phase 1 clinical development and has been studied in a completed trial involving healthy male subjects. The drug is not approved and remains under investigation for its potential effects on cognition.
SDI-118 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting early-stage clinical research on this investigational small molecule for cognitive disorders.
SDI-118 is in Phase 1 clinical development. It has completed one Phase 1 trial, which was a single ascending oral dose study in healthy male subjects. The drug is investigational and has not been approved for any use.
SDI-118 has been studied in one completed Phase 1 trial, identified as NCT05486195. This was a single ascending oral dose study in healthy male subjects, including an assessment of receptor occupancy and food effect. The trial enrolled 32 participants and was conducted in Belgium.
No alternative names for SDI-118 have been reported. The drug is identified solely by its code name SDI-118 in clinical trial records and development documentation.