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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05723692 | A First-In-Human SAD and MAD Study to Evaluate the Safety, Tolerability, PK and PD of SC Administered ALTB-268 in Healthy Volunteers | PHASE1 | COMPLETED | 56 | — | — | Jan 17, 2023 | Oct 27, 2023 | Feb 6, 2024 | 1 | United States |
Adverse events (AEs) - severity of the AEs will be graded using the most current version of the Common Terminology Criteria for AE (CTCAE) (V5.0) 5-point scale. The relationship between AEs and the study drug will be indicated as related or not related.
| Arm | Type | Description |
|---|---|---|
| ALTB-268 | EXPERIMENTAL | Subcutaneous dose in healthy volunteers |
| Placebo | PLACEBO_COMPARATOR | Subcutaneous dose in healthy volunteers |
| Name | Type | Description |
|---|---|---|
| ALTB-268 | BIOLOGICAL | monoclonal antibody |
| Placebo | OTHER | formulation buffer |
Inclusion Criteria: 1. Written Informed Consent and willingness to comply with the study restrictions. 2. Sex: male or female volunteers. 3. Age: 18 to 55 years, inclusive, at screening. 4. Body mass index (BMI): 18.0 to 32.0 kg/m2, inclusive, at screening. 5. Weight: 50 kg to 110 kg, inclusive, at...