Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SHP681 · 1 trial · 1 indication
Adverse event (AE) was any unfavorable and unintended sign, symptom, or disease temporally associated with study or use of investigational drug product (IP), whether or not the AE was considered related to IP. TEAEs: AEs occurring or worsening at or after first dose of IP or ongoing at time of enrollment. SAE :untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. Severity: Mild: event that does not generally interfere with usual activities of daily living; Moderate: event that interferes with usual activities of daily living, causing discomfort, permanent risk of harm; Severe: AE that interrupts usual activities of daily living, significantly affects clinical status, or may require intensive therapeutic intervention.
AE was any unfavorable and unintended sign, symptom, or disease temporally associated with study or use of investigational drug product (IP), whether or not the AE was considered related to IP. TEAEs: AEs occurring or worsening at or after first dose of IP or ongoing at time of enrollment. SAE :untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. Severity: Mild: event that does not generally interfere with usual activities of daily living; Moderate: event that interferes with usual activities of daily living, causing discomfort, permanent risk of harm; Severe: AE that interrupts usual activities of daily living, significantly affects clinical status, or may require intensive therapeutic intervention.
Antibody testing was conducted using an electro chemiluminescent signal method. Number of participants with ADA to SHP681 in SAD at Day 29 were reported.
Antibody testing was conducted using an electro chemiluminescent signal method. Number of participants with ADA to SHP681 in MAD at Day 36 were reported.
Antibody testing was conducted using an electro chemiluminescent signal method. Number of participants with ADA to SHP681 in MAD at Day 57 were reported.
| Arm | Type | Description |
|---|---|---|
| Single Ascending Dose (SAD): 0.2 mg/kg | EXPERIMENTAL | Participants will receive single subcutaneous (SC) injection of 0.2 mg/kg SHP681 in the abdomen. |
| Single Ascending Dose (SAD): 0.5 mg/kg | EXPERIMENTAL | Participants will receive single SC injection of 0.5 mg/kg SHP681 in the abdomen. |
| Single Ascending Dose (SAD): 1 mg/kg | EXPERIMENTAL | Participants will receive single SC injection of 1 mg/kg SHP681 in the abdomen. |
| Single Ascending Dose (SAD): 2 mg/kg | EXPERIMENTAL | Participants will receive single SC injection of 2 mg/kg SHP681 in the abdomen. |
| Single Ascending Dose (SAD): 4 mg/kg | EXPERIMENTAL | Participants will receive single SC injection of 4 mg/kg SHP681 in the abdomen. |
| Single Ascending Dose (SAD): Placebo | PLACEBO_COMPARATOR | Participants will receive single SC injection of placebo matched to SHP681 in the abdomen. |
| Multiple Ascending Dose (MAD): 0.2 mg/kg | EXPERIMENTAL | Participants will receive SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen. |
| Multiple Ascending Dose (MAD): 0.5 mg/kg | EXPERIMENTAL | Participants will receive SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen. |
| Multiple Ascending Dose (MAD): 1 mg/kg | EXPERIMENTAL | Participants will receive SC injection of 1 mg/kg SHP681 once weekly for 5 weeks in the abdomen. |
| Multiple Ascending Dose (MAD): 2 mg/kg | EXPERIMENTAL | Participants will receive SC injection of 2 mg/kg SHP681 once weekly for 5 weeks in the abdomen. |
| Multiple Ascending Dose (MAD): 4 mg/kg | EXPERIMENTAL | Participants will receive SC injection of 4 mg/kg SHP681 once weekly for 5 weeks in the abdomen. |
| Multiple Ascending Dose (MAD): Placebo | PLACEBO_COMPARATOR | Participants will receive SC injection of placebo matched to SHP681 once weekly for 5 weeks in the abdomen. |
| Name | Type | Description |
|---|---|---|
| SHP681 | DRUG | Participants will receive SC injection of SHP681 in the abdomen. |
| Placebo | OTHER | Participants will receive SC injection of placebo matched to SHP681 in the abdomen. |
Inclusion Criteria: * Ability to voluntarily provide written, signed, and dated informed consent to participate in the study. * An understanding, ability, and willingness to fully comply with study procedures and restrictions. * Age 18-50 inclusive at the time of consent. The date of signature of t...
SHP681 is an investigational small molecule developed by Takeda Pharmaceutical Company Limited. It has been studied in a Phase 1 clinical trial in healthy adult volunteers. The specific disease or condition it is intended to treat has not been publicly disclosed, and it is not approved for any use.
SHP681 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda sponsored the Phase 1 study of SHP681 conducted in the United States. No partnership or licensing arrangement for this asset has been disclosed.
SHP681 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The completed study was a randomized, double-blind, placebo-controlled trial of ascending subcutaneous single and multiple doses in healthy adult participants.
SHP681 has been evaluated in one completed Phase 1 trial, NCT03859323, titled a study to assess the safety, tolerability, and pharmacokinetics of ascending subcutaneous single and multiple doses of SHP681 in healthy adult participants. The trial enrolled 104 participants in the United States and has completed.
SHP681 is not approved. It is an investigational drug that has completed a single Phase 1 clinical trial in healthy adult volunteers. Phase 1 studies assess safety, tolerability, and pharmacokinetics rather than confirmatory efficacy, and further clinical development would be required before any regulatory review.
The Phase 1 trial NCT03859323 assessed the safety, tolerability, and pharmacokinetics of ascending subcutaneous single and multiple doses of SHP681 in healthy adult participants. It was randomized, double-blind, and placebo-controlled, enrolling 104 participants aged 18 years and older in the United States.