A Phase 1, Single Dose, Open-Label, Parallel Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INCA033989 Following Subcutaneous or Intravenous Administration in Healthy Adult Participants
Incyte Corporation
Summary
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.
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Ability to comprehend the study procedures, provide a signed ICF, and comply with all Protocol requirements. * Healthy, age 18 to 55 years, inclusive, at the time of signing the ICF, with no significant past or current medical history. * Body mass index between 18.0 and 30.0 kg/m2, inclusive, at screening. Note: Up to 25% of the participants in each cohort may be enrolled with a BMI \> 30 to ≤ 32.0 kg/m2. * No clinically significant findings during screening and check-in (Day -1) for evaluations (eg, clinical, laboratory, vital signs, ECG). Tests with results that fail e…
Interventions
- DrugINCA033989
INCA033989 will be administered at protocol defined dose.
- DrugBioavailability enhancer
A bioavailability enhancer will be administered with INCA033989 at protocol defined dose.
Location
- Celerion Clinical Research UnitTempe, Arizona