Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| J1L-AM-JZGE | Other Identifier | Eli Lilly and Company | |
| AM0010-801 | Other Identifier | ARMO BioSciences |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ARMO BioSciences | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
To evaluate the pharmacokinetics of single and multiple doses of pegilodecakin in healthy participants.
This is an open-label, single-center, phase 1 study designed to evaluate the pharmacokinetics in healthy adult participants after single and multiple subcutaneous injections of pegilodecakin.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Pegilodecakin (5 μg/kg) dosed on Day 1, and Days 4-9 SQ |
|
| 2 | Active Comparator | Pegilodecakin (10 μg/kg) dosed on Day 1, and Days 4-9 SQ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegilodecakin | Biological | Pegilodecakin Alone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters, Cmax | maximal plasma concentration (Cmax) | 43 days |
| Pharmacokinetic parameters, Tmax | maximal concentration (Tmax) | 43 days |
| Pharmacokinetic parameters, AUC | area under the plasma concentration curve (AUC) | 43 days |
| Pharmacokinetic parameters, CL/F | clearance (CL/F). | 43 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | Evaluate the safety of single/multiple SQ doses of Pegilodecakin - Incidence of adverse events, injection site reactions, clinically relevant changes in laboratory values, EKGs, and vital signs | 43 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Development | Austin | Texas | 78744 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 10, 2026 | |
| Reset | Jul 6, 2026 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 10, 2026 | Jul 6, 2026 |
| ID | Term |
|---|---|
| C000632591 | pegilodecakin |
| C000622455 | AM0010 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided