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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05154968 | A Study of Two Formulations (Both Refrigerated and Room Temperature) Using an Autoinjector Device in Healthy Participants | PHASE1 | COMPLETED | 44 | — | — | Nov 24, 2021 | Dec 14, 2021 | Jan 13, 2022 | 1 | Canada |
The Infusion site pain VAS score is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (worst possible pain).
| Arm | Type | Description |
|---|---|---|
| Sequence 1 (ABCD) | EXPERIMENTAL | Participants will receive 1 millilitre (ml) subcutaneous (SC) injection of treatment A (higher pain refrigerated solution is a formulation matrix solution of an acidic solution citrate buffer and sodium chloride at the potential of hydrogen (pH) 5.7) followed by treatments B (higher pain Room Temperature \[RT\] solution is a formulation matrix solution of an acidic solution containing citrate buffer and sodium chloride at pH 5.7), C (lower pain refrigerated solution contains mannitol), and D (lower pain RT solution contains mannitol) in the right upper quadrant, left upper quadrant, right lower quadrant, and left lower quadrant respectively using a prefilled autoinjector device. |
| Sequence 2 (BDAC) | EXPERIMENTAL | Participants will receive 1 ml SC injection of treatment B (higher pain RT solution is a formulation matrix solution of an acidic solution containing citrate buffer and sodium chloride at pH 5.7) followed by treatments D (lower pain RT solution contains mannitol), A (higher pain refrigerated solution is a formulation matrix solution of an acidic solution citrate buffer and sodium chloride at pH 5.7), and C (lower pain refrigerated solution contains mannitol) in the right upper quadrant, left upper quadrant, right lower quadrant, and left lower quadrant respectively using a prefilled autoinjector device. |
| Sequence 3 (CADB) | EXPERIMENTAL | Participants will receive 1 ml SC injection of treatment C (lower pain refrigerated solution contains mannitol) followed by treatments A (higher pain refrigerated solution is a formulation matrix solution of an acidic solution citrate buffer and sodium chloride at pH 5.7), D (lower pain RT solution contains mannitol), and B (higher pain RT solution is a formulation matrix solution of an acidic solution containing citrate buffer and sodium chloride at pH 5.7) in the right upper quadrant, left upper quadrant, right lower quadrant, and left lower quadrant respectively using a prefilled autoinjector device. |
| Sequence 4 (DCBA) | EXPERIMENTAL | Participants will receive 1 ml SC injection of treatment D (lower pain RT solution contains mannitol) followed by treatments C (lower pain refrigerated solution contains mannitol), B (higher pain RT solution is a formulation matrix solution of an acidic solution containing citrate buffer and sodium chloride at pH 5.7), and A (higher pain refrigerated solution is a formulation matrix solution of an acidic solution citrate buffer and sodium chloride at pH 5.7), in the right upper quadrant, left upper quadrant, right lower quadrant, and left lower quadrant respectively using a prefilled autoinjector device. |
| Name | Type | Description |
|---|---|---|
| Sodium chloride | DRUG | Administered SC infusion. |
| Citrate buffer | DRUG | Administered SC infusion. |
| Mannitol | DRUG | Administered SC infusion. |
| Prefilled Autoinjector | DEVICE | Used to administer the drug through SC infusion. |
Inclusion Criteria: * Non-smoker * BMI greater than (\>)18.5 and less than (\<) 30.0 kilograms per square meter (kg/m2) * Body weight greater than or equal to (≥) 50.0 kg for males and ≥45.0 kg for females * Are in good health, as determined by the investigator (or designee) to have no clinically s...