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 Corporation1 个研究点分布在 1 个国家目标入组 126 人开始时间: 2026年3月19日最近更新: 2026年7月8日

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方: Incyte Corporation
入组人数: 126
试验地点: 1
主要终点: Pharmacokinetics Parameter: Cmax of INCA33989 following a single SC administration compared with a single IV infusion

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•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/m
•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 treatment 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).

排除标准

•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 ethanol test (urine or breath) 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 treatment 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 treatment administration, or use of nonprescription medication/products (including minerals, herbal, phytotherapeutic, or plant-derived preparations) within 7 days prior to study treatment 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 treatment 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.
•Previous treatment with INCA
•Other protocol-defined Inclusion/Exclusion Criteria may apply.

研究组 & 干预措施

Cohort 4

Experimental

INCA033989 will be administered at protocol defined dose administered as a SC injection.

干预措施: INCA033989 (Drug)

Cohort 2

Experimental

INCA033989 will be administered at protocol defined dose administered as a SC injection.

干预措施: INCA033989 (Drug)

Cohort 1

Experimental

INCA033989 will be administered at protocol defined dose administered as a SC injection.

干预措施: INCA033989 (Drug)

Cohort 3

Experimental

INCA033989 will be administered at protocol defined dose administered as an IV infusion.

干预措施: INCA033989 (Drug)