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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03859323 | A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ascending, Subcutaneous, Single and Multiple Doses of SHP681 (Glucagon-like Peptide-2 [GLP-2] Analog-Fc Fusion) in Healthy Adult Participants | PHASE1 | COMPLETED | 104 | — | — | Mar 26, 2019 | Jan 6, 2020 | Feb 25, 2021 | 1 | United States |
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...