Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SHP643 · 1 trial · 1 indication
AUC(0-last) of SHP643 in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
AUC(0-infinity) of SHP643 in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
Cmax is the maximum observed plasma concentration of SHP643 in Plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
Tmax of of SHP643 in plasma was reported.
t1/2 of of SHP643 in plasma was reported.
CL/F of of SHP643 in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
Vdz/F of SHP643 in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
Lambda z of SHP643 in Plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
| Arm | Type | Description |
|---|---|---|
| SHP643 Prefilled Syringe (PFS) | EXPERIMENTAL | Participants will receive 300 milligram (mg) of SHP643 PFS Subcutaneous (SC) injection into the abdomen on Day 1 during the in-house period (Day 1 to Day 5). |
| SHP643 Autoinjector (AI) | EXPERIMENTAL | Participants will receive 300 mg of SHP643 AI SC injection into the abdomen on Day 1 during the in-house period (Day 1 to Day 5). |
| Name | Type | Description |
|---|---|---|
| SHP643 | DRUG | Participants will receive injection of SHP643. |
Inclusion Criteria: * An understanding, ability, and willingness to fully comply with study procedures and restrictions. * Ability to voluntarily provide written, signed, and dated informed consent to participate in the study. * Age 18-55, inclusive, at the time of consent. The date of signature of...
SHP643 is an investigational small molecule being studied in healthy volunteers. It is being evaluated in a Phase 1 clinical trial to determine the bioavailability of the drug when administered subcutaneously with a prefilled syringe and an autoinjector. The study is completed and enrolled 190 participants in the United States.
SHP643 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical research on this investigational drug in healthy adult volunteers.
SHP643 is in Phase 1 clinical development. The single trial for this drug has been completed, with 190 participants enrolled. The study was controlled and randomized, though it was not double-blind. SHP643 remains investigational and has not been approved by regulatory authorities.
SHP643 has one completed clinical trial, identified as NCT03918239. The study, titled "A Study to Determine the Bioavailability of Lanadelumab (SHP643) Administered Subcutaneously With the Prefilled Syringe and the Autoinjector in Healthy Adult Volunteer Participants," enrolled 190 healthy adults aged 18 years and older in the United States.
Yes, SHP643 is also known as Lanadelumab. The clinical trial NCT03918239 refers to the drug as Lanadelumab (SHP643), indicating that both names are used for the same investigational compound. The study evaluates its bioavailability when given subcutaneously via different delivery devices.