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This study is being conducted to evaluate the pharmacokinetics, safety, and tolerability of INCA033989 following subcutaneous (SC) or intravenous administration (IV) n healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | INCA033989 will be administered at protocol defined dose administered as a SC injection. |
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| Cohort 2 | Experimental | INCA033989 will be administered at protocol defined dose administered as a SC injection. |
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| Cohort 3 | Experimental | INCA033989 will be administered at protocol defined dose administered as an IV infusion. |
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| Cohort 4 | Experimental | INCA033989 will be administered at protocol defined dose administered as a SC injection. |
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| Cohort 5 | Experimental | INCA033989 in combination with a bioavailability enhancer will be administered at protocol defined dose administered as a SC injection. |
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| Cohort 6 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCA033989 | Drug | INCA033989 will be administered at protocol defined dose. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics Parameter: Cmax of INCA33989 following a single SC administration compared with a single IV infusion | Defined as maximum observed plasma concentration of INCA033989. | Up to 12 weeks |
| Pharmacokinetics Parameter: AUClast of INCA33989 following a single SC administration compared with a single IV infusion | Defined as area under the concentration-time curve from time zero to time of the last quantifiable concentration (Clast) of INCA033989. | Up to 12 weeks |
| Pharmacokinetics Parameter: AUC0∞ of INCA33989 following a single SC administration compared with a single IV infusion | Defined as area under the single-dose concentration-time curve extrapolated to time of infinity of INCA033989. | Up to 12 weeks |
| Number of participants with Treatment-emergent Adverse Events (TEAEs) | Defined as adverse events reported for the first time or the worsening of a pre-existing event, occurring after study drug administration. | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics Parameter: tmax of INCA33989 following a single SC administration | Defined as time to maximum concentration of INCA33989. | Up to 12 weeks |
| Pharmacokinetics Parameter: t1/2 of INCA33989 following a single SC administration |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion Criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Incyte Corporation Call Center (US) | Contact | 1.855.463.3463 | medinfo@incyte.com | |
| Incyte Corporation Call Center (ex-US) | Contact | +800 00027423 | eumedinfo@incyte.com |
| Name | Affiliation | Role |
|---|---|---|
| Incyte Medical Monitor | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion Clinical Research Unit | Recruiting | Tempe | Arizona | 85283 | United States |
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| Label | URL |
|---|---|
| A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INCA033989 Following Subcutaneous or Intravenous Administration in Healthy Adult Participants | View source |
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INCA033989 in combination with a bioavailability enhancer will be administered at protocol defined dose administered as a SC injection. |
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| Cohort 7 | Experimental | INCA033989 in combination with a bioavailability enhancer will be administered at protocol defined dose administered as a SC injection. |
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| Bioavailability enhancer | Drug | A bioavailability enhancer will be administered with INCA033989 at protocol defined dose. |
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Defined as the apparent terminal phase disposition half-life of INCA33989.
| Up to 12 weeks |
| Pharmacokinetics Parameter: CL/F of INCA33989 following a single SC administration | Defined as the apparent dose clearance of INCA33989. | Up to 12 weeks |
| Pharmacokinetics Parameter: Vz/F of INCA33989 following a single SC administration | Defined as the apparent volume of distribution of INCA033989. | Up to 12 weeks |
| Pharmacokinetics Parameter: tmax of INCA33989 following a single IV infusion | Defined as time to maximum concentration of INCA33989. | Up to 12 weeks |
| Pharmacokinetics Parameter: t1/2 of INCA33989 following a single IV infusion | Defined as the apparent terminal phase disposition half-life of INCA33989. | Up to 12 weeks |
| Pharmacokinetics Parameter: CL of INCA33989 following a single IV infusion | Defined as the total systemic clearance of INCA033989. | Up to 12 weeks |
| Pharmacokinetics Parameter: Vss of INCA33989 following a single IV infusion | Defined as the volume of distribution at steady state of INCA033989. | Up to 12 weeks |
| ID | Term |
|---|---|
| D000097082 | Bioenhancers |
| ID | Term |
|---|---|
| D000277 | Adjuvants, Pharmaceutic |
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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