About this trial
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 criteria
Qualifiers
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 eligibility requirements may be repeated once during screening.
Disqualifiers
History of rheumatologic/autoimmune disorders, except for minor eczema and rosacea.
Participants with laboratory values outside the normal reference range at screening or check-in (see Appendix B for required analytes), including hemoglobin, WBC count, platelet count, or absolute neutrophil count, will be evaluated for clinical significance and eligibility by the investigator or qualified designee.
History of malignancy within 5 years of screening, with the exception of cured basal cell or squamous cell carcinoma of the skin, ductal carcinoma in situ, or Gleason 6 prostate cancer.
Any major surgery within 4 weeks of screening.
Trial design
Treatments tested in this trial
- INCA033989
- Bioavailability enhancer
Treatment groups
7
Treatment groupsSee each treatment group below.