A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INCA033989 Following Subcutaneous or Intravenous Administration in Healthy Adult Participants
Purpose
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.
Condition
- Healthy Participants
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Sex
- All
- Accepts 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 eligibility requirements may be repeated once during screening. - Ability to receive study drug via IV or SC administration as per Protocol requirements. - Willingness to avoid pregnancy or fathering children. - Ability to understand and willingness to comply with study procedures and restrictions (including confinement to clinical site and restrictions of physical activity, use of recreational drugs, alcohol, and medications).
Exclusion Criteria
- 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. - Donation of blood to a blood bank or participation in a clinical study (except a screening visit) within 4 weeks of screening (within 2 weeks for donation of plasma only). - Blood transfusion within 4 months of check-in (Day -1). - Chronic or current active infectious disease requiring systemic antibiotics or antifungal or antiviral therapy, including previously treated latent tuberculosis. - Positive test for HBV, HCV, or HIV at screening. Participants with serologic findings consistent with prior HBV immunization or resolved HBV infection (eg, isolated anti HBs or anti-HBc positivity with negative HBsAg) may be included at the investigator's discretion. - History of chronic or recurrent edema or clinically significant allergic conditions, including urticaria, allergic rhinoconjunctivitis, seasonal atopy, food allergy, or latex allergy. - History of alcoholism or significant alcohol use (medical or self-reported) within 3 months of screening, defined as regular alcohol consumption > 21 units per week for males and > 14 units for females (1 unit = one-half pint of beer or a 25-mL shot of 40% spirit, 1.5-2 units = 125-mL glass of wine). - Consumption of alcohol within 72 hours prior to check-in (Day -1). - Receipt of any COVID-19 vaccines or any live (including attenuated) vaccines within 3 months prior to screening or anticipated need for such vaccines during the study. - Positive urine test for ethanol or positive urine drug screen for substances of abuse not attributed to permitted concomitant medications or dietary sources. - Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug with another investigational medication or current enrollment/participation in another investigational drug or investigational product study. - History of anaphylaxis or severe hypersensitivity reaction to any biologic therapy or injectable drug. - History of clinically significant drug allergies (eg, anaphylaxis, hepatotoxicity), as determined by the investigator. - Known hypersensitivity or severe allergic reaction to any of the INCA033989 components or excipients (eg, polysorbate 80, citrate buffer), as documented in the IB. - Known hypersensitivity, allergy, or history of significant skin reactions to medical adhesives or adhesive-backed medical devices. This includes but is not limited to reactions to adhesive tapes, bandages, band-aids, and skin patches including acrylic based products. - History of tobacco use or use of nicotine-containing products within 2 weeks of screening. - Use of prescription medications (including hormonal contraceptives) within 14 days prior to study drug administration, or use of nonprescription medication/products (including minerals, herbal, phytotherapeutic, or plant-derived preparations) within 7 days prior to study drug administration. Occasional use of standard-dose acetaminophen, ibuprofen, and standard-dose vitamins is permitted. Megadose vitamins or supplements are not permissible. - Women who are pregnant or breastfeeding. - Any condition that, in the opinion of the investigator, may interfere with the participant's ability to fully comply with the study Protocol (including administration of the study drug and attendance at required visits), pose a significant safety risk to the participant, or compromise the integrity of study data or its interpretation. - History of keloid formation or hypertrophic scarring, which may increase the risk of ISRs following SC dose administration, as determined by the investigator. - Abdominal tattoos or scarring at the injection site. Other protocol-defined Inclusion/Exclusion Criteria may apply.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cohort 1 |
INCA033989 will be administered at protocol defined dose administered as a SC injection. |
|
|
Experimental Cohort 2 |
INCA033989 will be administered at protocol defined dose administered as a SC injection. |
|
|
Experimental Cohort 3 |
INCA033989 will be administered at protocol defined dose administered as an IV infusion. |
|
|
Experimental Cohort 4 |
INCA033989 will be administered at protocol defined dose administered as a SC injection. |
|
Recruiting Locations
Celerion Clinical Research Unit
Tempe, Arizona 85283
Tempe, Arizona 85283
More Details
- Status
- Recruiting
- Sponsor
- Incyte Corporation