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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06698939 | ORKA-001 in Healthy Volunteers | PHASE1 | COMPLETED | 24 | — | — | Dec 19, 2024 | Mar 13, 2026 | Apr 1, 2026 | 1 | New Zealand |
Incidence of treatment-emergent adverse events (TEAEs) and clinically significant changes from baseline in vital signs, electrocardiograms (ECGs), clinical laboratory parameters, and physical examinations.
| Arm | Type | Description |
|---|---|---|
| ORKA-001 | EXPERIMENTAL | Participants will receive subcutaneous injection of ORKA-001 at either 300 mg, 600 mg or 1200 mg. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a subcutaneous injection of placebo comparator. |
| Name | Type | Description |
|---|---|---|
| ORKA-001 | DRUG | ORKA-001 is supplied as sterile solution to be administered by SC injection |
| Placebo | OTHER | Placebo solution to be administered at a matching volume by SC injection |
Key Inclusion Criteria: 1. Healthy male or female participants 2. 18 to 65 years (inclusive) with a body mass index (BMI) 18 to 32 kg/m2 3. Willing and able to remain at the study site unit for the duration of the confinement period and return for the outpatient visit/s defined in the protocol 4. U...