Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
chloride · 1 trial · 1 indication
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...
Chloride is an investigational small molecule being developed by Eli Lilly and Company (LLY). It is currently in Phase 1 clinical development for use in healthy participants. The drug is not approved and remains under investigation.
Chloride is being studied for use in healthy participants. The Phase 1 trial is designed to evaluate the drug in this population, though no specific therapeutic indication has been established for the compound at this stage of development.
Chloride is being developed by Eli Lilly and Company, a biopharmaceutical company traded on the NYSE under the ticker symbol LLY. The company is conducting clinical research on this investigational small molecule.
Chloride is in Phase 1 clinical development. One Phase 1 trial has been completed, and there are no active trials currently enrolling. The drug remains investigational and has not been approved by regulatory authorities.
Chloride has one completed Phase 1 clinical trial, NCT05154968, which studied two formulations using an autoinjector device in healthy participants. The trial enrolled 44 participants in Canada and was a controlled, randomized study.
No alternative names for chloride have been reported. The compound is referred to only as chloride in the available clinical trial information from Eli Lilly and Company.