A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INCA033989 Following Subcutaneous or Intravenous Administration in Healthy Adult Participants

NCT07448155 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: INCA033989-103
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants

Keywords

INCA033989

Outcome Measures

Primary Outcomes (4)

• Pharmacokinetics Parameter: Cmax of INCA33989 following a single SC administration compared with a single IV infusion

  Defined as maximum observed plasma concentration of INCA033989.

  Up to 12 weeks

• Pharmacokinetics Parameter: AUClast of INCA33989 following a single SC administration compared with a single IV infusion

  Defined as area under the concentration-time curve from time zero to time of the last quantifiable concentration (Clast) of INCA033989.

  Up to 12 weeks

• Pharmacokinetics Parameter: AUC0∞ of INCA33989 following a single SC administration compared with a single IV infusion

  Defined as area under the single-dose concentration-time curve extrapolated to time of infinity of INCA033989.

  Up to 12 weeks

• Number of participants with Treatment-emergent Adverse Events (TEAEs)

  Defined as adverse events reported for the first time or the worsening of a pre-existing event, occurring after study drug administration.

  Up to 12 weeks

Secondary Outcomes (8)

• Pharmacokinetics Parameter: tmax of INCA33989 following a single SC administration

  Up to 12 weeks

• Pharmacokinetics Parameter: t1/2 of INCA33989 following a single SC administration

  Up to 12 weeks

• Pharmacokinetics Parameter: CL/F of INCA33989 following a single SC administration

  Up to 12 weeks

• Pharmacokinetics Parameter: Vz/F of INCA33989 following a single SC administration

  Up to 12 weeks

• Pharmacokinetics Parameter: tmax of INCA33989 following a single IV infusion

  Up to 12 weeks

Study Arms (4)

Cohort 1

EXPERIMENTAL

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

Drug: INCA033989

Cohort 2

EXPERIMENTAL

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

Drug: INCA033989

Cohort 3

EXPERIMENTAL

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

Drug: INCA033989

Cohort 4

EXPERIMENTAL

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

Drug: INCA033989

Interventions

INCA033989 DRUG

INCA033989 will be administered at protocol defined dose.

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (1)

Celerion Clinical Research Unit

Tempe, Arizona, 85283, United States

Location

Related Links

• A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INCA033989 Following Subcutaneous or Intravenous Administration in Healthy Adult Participants

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 4, 2026
• Study Start: March 19, 2026
• Primary Completion (Estimated): October 19, 2026
• Study Completion (Estimated): October 19, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)