Study of INCA033989 in Healthy Adults
This study is looking for healthy adults aged 18 to 55 to help us understand a new drug called INCA033989. We want to see how the body handles INCA033989 when given in two different ways: under the skin (subcutaneous) or directly into a vein (intravenous). We'll also be checking for any side effects to make sure it's safe. The study will measure how much of the drug is in your body and for how long after a single dose. We plan to enroll 126 participants. The current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 126 healthy adult participants. It will compare how the body handles INCA033989 when given under the skin versus into a vein.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 12 weeks after receiving the drug to measure drug levels in their body.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07448155
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INCA033989 Following Subcutaneous or Intravenous Administration in Healthy Adult Participants
Recruiting
PHASE1Ages 18–55InterventionalTreatmentIncyte Corporation
~126 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:INCA033989Bioavailability enhancer
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pharmacokinetics Parameter: Cmax of INCA33989 following a single SC administration compared with a single IV infusion
Measured over Up to 12 weeks
+3 more outcomes measured
Conditions
NCT07448155
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Celerion Clinical Research Unit
Tempe, Arizonano site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Incyte Medical Monitor · STUDY_DIRECTOR · Incyte Corporation
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Eligibility criteria
Inclusion
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 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).
Exclusion
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 INCA033989.
What this trial measures
- Pharmacokinetics Parameter: Cmax of INCA33989 following a single SC administration compared with a single IV infusionUp to 12 weeks
Defined as maximum observed plasma concentration of INCA033989.
- Pharmacokinetics Parameter: AUClast of INCA33989 following a single SC administration compared with a single IV infusionUp to 12 weeks
Defined as area under the concentration-time curve from time zero to time of the last quantifiable concentration (Clast) of INCA033989.
- Pharmacokinetics Parameter: AUC0∞ of INCA33989 following a single SC administration compared with a single IV infusionUp to 12 weeks
Defined as area under the single-dose concentration-time curve extrapolated to time of infinity of INCA033989.
- Number of participants with Treatment-emergent Adverse Events (TEAEs)Up to 12 weeks
Defined as adverse events reported for the first time or the worsening of a pre-existing event, occurring after study drug administration.