Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07618247 | Single Ascending Doses (SAD) and Multiple Ascending Doses(MAD) Study of IG001119 in Healthy Adult Participants | PHASE1 | NOT YET_RECRUITING | 64 | — | — | Jun 4, 2026 | May 30, 2027 | Jun 3, 2026 | 1 | Australia |
* Safety: Incidence and severity of adverse events (AEs), vital signs (pulse rate, respiratory rate, blood pressure, body temperature), physical examination, laboratory tests, electrocardiogram (ECG), etc. * AEs will be described in terms of result, frequency, intensity, medical decision, relation with study drug, as well as treatment received and subject retirement, duration, and time elapsed. AEs will also be listed and coded using the Medical Dictionary for Regulatory Activities (MedDRA) Dictionary for the term's codification.
* Safety: Incidence and severity of adverse events (AEs), vital signs (pulse rate, respiratory rate, blood pressure, body temperature), physical examination, laboratory tests, electrocardiogram (ECG), etc. * AEs will be described in terms of result, frequency, intensity, medical decision, relation with study drug, as well as treatment received and subject retirement, duration, and time elapsed. AEs will also be listed and coded using the MedDRA Dictionary for the term's codification.
| Arm | Type | Description |
|---|---|---|
| IG001119 Single Ascending Doses (SAD) | EXPERIMENTAL | - |
| Placebo Single Ascending Doses (SAD) | PLACEBO_COMPARATOR | - |
| IG001119 Multiple Ascending Doses(MAD) | EXPERIMENTAL | - |
| Placebo Multiple Ascending Doses(MAD) | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Tablets for oral administration. |
| IG001119 | DRUG | Tablets for oral administration. |
Key Inclusion Criteria: 1. Participants who have signed the informed consent form (ICF) prior to the study, fully understand the content, procedures and possible adverse reactions of the study, and are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle...