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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07050511 | Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GB-0669 in Healthy Adult Participants | PHASE1 | COMPLETED | 51 | — | — | Jul 18, 2023 | Nov 22, 2024 | Jul 3, 2025 | 1 | United States |
Participant incidence and severity of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to discontinuation of study treatment. Clinically significant (CS) changes from baseline in: Clinical laboratory results (hematology, clinical chemistry, coagulation and urinalysis, vital signs, twelve-lead electrocardiograms (ECGs).
| Arm | Type | Description |
|---|---|---|
| Study Intervention GB-0669 | EXPERIMENTAL | Study intervention |
| Placebo | PLACEBO_COMPARATOR | sterile 0.9% (w/v) sodium chloride solution |
| Name | Type | Description |
|---|---|---|
| GB-0669 | DRUG | Single IV infusion of GB-0669. |
| Placebo | DRUG | Single IV infusion of placebo. Sterile 0.9% (w/v) sodium chloride solution. |
Inclusion Criteria: 1. Must have given written informed consent before any study-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 55 years of age (inclusive) at screening 3. Body...