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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06920693 | Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GB-7624 in Healthy Adult Participants | PHASE1 | ACTIVE NOT_RECRUITING | 40 | — | — | Mar 27, 2025 | Dec 30, 2026 | Dec 5, 2025 | 1 | Australia |
Participant incidence and severity of treatment-emergent adverse events (TEAEs), serious AEs (SAEs),and TEAEs leading to discontinuation of study treatment. Clinically significant (CS) changes from baseline in: * Clinical laboratory results (haematology, clinical chemistry, coagulation and urinalysis) * Vital signs * Twelve-lead electrocardiograms (ECGs)
Participant incidence and severity of treatment-emergent AEs (TEAEs), serious AEs (SAEs), and TEAEs leading to discontinuation of study treatment. Clinically significant (CS) changes from baseline in: * Clinical laboratory results (haematology, clinical chemistry, coagulation and urinalysis) * Vital signs * Twelve-lead electrocardiograms (ECGs)
| Arm | Type | Description |
|---|---|---|
| Study intervention: GB-7624 | EXPERIMENTAL | - |
| Study Intervention: Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| GB-7624 | DRUG | Study Drug GB-7624 |
| Placebo | DRUG | Placebo |
Inclusion Criteria: 1. Participants must have given written informed consent before any trial-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects. 2. Adults, 18 to 65 years of age (inclusive) at the...