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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06650761 | A Phase I Study of CDX-622 | PHASE1 | COMPLETED | 85 | — | — | Nov 1, 2024 | Apr 24, 2026 | May 4, 2026 | 1 | United States |
To evaluate the safety profile as determined by the incidence of adverse events in single or multiple ascending doses of CDX-622 or placebo comparator in healthy participants.
| Arm | Type | Description |
|---|---|---|
| CDX-622 | EXPERIMENTAL | Eligible participants will receive doses of CDX-622 by IV or SC |
| Normal Saline | PLACEBO_COMPARATOR | Eligible participants will receive doses of Normal Saline by IV or SC |
| Name | Type | Description |
|---|---|---|
| CDX-622 | DRUG | Up to 4 infusions of one of seven dosages of CDX-622 or up to 1 dose by subcutaneous injection of one of three dosages of CDX-622 |
| Normal Saline | DRUG | Up to 4 infusions or 6 SC injections of normal saline |
Key Inclusion Criteria: * An informed consent signed and dated by the participant. * Healthy volunteer aged 18-55. * In generally good health and without significant medical conditions based on physical exam, ECG, and laboratory test results. * Body mass index (BMI) ≥ 18 kg/m2 to ≤ 32 kg/m2. * No c...