Healthy ParticipantsPhase 1NCT07448155
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INCA033989 Following Subcutaneous or Intravenous Administration in Healthy Adult Participants
A Phase 1 study testing INCA033989 and Bioavailability enhancer in people with Healthy Participants, run by Incyte Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- INCA033989 and Bioavailability enhancer
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2026to 14 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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).
Show all 26Show fewer
- 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.
- Other protocol-defined Inclusion/Exclusion Criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Celerion Clinical Research Unit
Tempe, Arizona, 85283
About this study
Official title: 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
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
- Being tested
- INCA033989, Bioavailability enhancer
- Keywords
- INCA033989
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCA033989Drug
INCA033989 will be administered at protocol defined dose.
Bioavailability enhancerDrug
A bioavailability enhancer will be administered with INCA033989 at protocol defined dose.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | INCA033989 will be administered at protocol defined dose administered as a SC injection. Receives: Drug: INCA033989 |
| Cohort 2 | Experimental | INCA033989 will be administered at protocol defined dose administered as a SC injection. Receives: Drug: INCA033989 |
| Cohort 3 | Experimental | INCA033989 will be administered at protocol defined dose administered as an IV infusion. Receives: Drug: INCA033989 |
| Cohort 4 | Experimental | INCA033989 will be administered at protocol defined dose administered as a SC injection. Receives: Drug: INCA033989 |
| Cohort 5 | Experimental | INCA033989 in combination with a bioavailability enhancer will be administered at protocol defined dose administered as a SC injection. Receives: Drug: INCA033989; Drug: Bioavailability enhancer |
| Cohort 6 | Experimental | INCA033989 in combination with a bioavailability enhancer will be administered at protocol defined dose administered as a SC injection. Receives: Drug: INCA033989; Drug: Bioavailability enhancer |
| Cohort 7 | Experimental | INCA033989 in combination with a bioavailability enhancer will be administered at protocol defined dose administered as a SC injection. Receives: Drug: INCA033989; Drug: Bioavailability enhancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics Parameter: Cmax of INCA33989 following a single SC administration compared with a single IV infusion
Defined as maximum observed plasma concentration of INCA033989.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 weeks
Secondary outcomes (8)
Pharmacokinetics Parameter: tmax of INCA33989 following a single SC administration
Defined as time to maximum concentration of INCA33989.
Measured: Up to 12 weeks
Pharmacokinetics Parameter: t1/2 of INCA33989 following a single SC administration
Defined as the apparent terminal phase disposition half-life of INCA33989.
Measured: Up to 12 weeks
Pharmacokinetics Parameter: CL/F of INCA33989 following a single SC administration
Defined as the apparent dose clearance of INCA33989.
Measured: Up to 12 weeks
Pharmacokinetics Parameter: Vz/F of INCA33989 following a single SC administration
Defined as the apparent volume of distribution of INCA033989.
Measured: Up to 12 weeks
Pharmacokinetics Parameter: tmax of INCA33989 following a single IV infusion
Defined as time to maximum concentration of INCA33989.
Measured: Up to 12 weeks
Pharmacokinetics Parameter: t1/2 of INCA33989 following a single IV infusion
Defined as the apparent terminal phase disposition half-life of INCA33989.
Measured: Up to 12 weeks
Pharmacokinetics Parameter: CL of INCA33989 following a single IV infusion
Defined as the total systemic clearance of INCA033989.
Measured: Up to 12 weeks
Pharmacokinetics Parameter: Vss of INCA33989 following a single IV infusion
Defined as the volume of distribution at steady state of INCA033989.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start19 Mar 2026
- Primary completion14 Nov 2026 (estimated)
- Study completion14 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448155
- Sponsor's protocol ID
- INCA033989-103
- Status last verified
- Oct 2026
- First submitted
- 26 Feb 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07448155
- Acronym / sponsor ID
- INCA033989-103
- Conditions
- Healthy Participants
- Keywords
- INCA033989
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 14 Nov 2026 (estimated)
- Study completion
- 14 Nov 2026 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: INCA033989INCA033989 will be administered at protocol defined dose administered as a SC injection. |
| Cohort 2 | Experimental | Drug: INCA033989INCA033989 will be administered at protocol defined dose administered as a SC injection. |
| Cohort 3 | Experimental | Drug: INCA033989INCA033989 will be administered at protocol defined dose administered as an IV infusion. |
| Cohort 4 | Experimental | Drug: INCA033989INCA033989 will be administered at protocol defined dose administered as a SC injection. |
| Cohort 5 | Experimental | Drug: INCA033989, Drug: Bioavailability enhancerINCA033989 in combination with a bioavailability enhancer will be administered at protocol defined dose administered as a SC injection. |
| Cohort 6 | Experimental | Drug: INCA033989, Drug: Bioavailability enhancerINCA033989 in combination with a bioavailability enhancer will be administered at protocol defined dose administered as a SC injection. |
| Cohort 7 | Experimental | Drug: INCA033989, Drug: Bioavailability enhancerINCA033989 in combination with a bioavailability enhancer will be administered at protocol defined dose administered as a SC injection. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (26 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCA033989INCA033989 will be administered at protocol defined dose. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7 |
| Bioavailability enhancerA bioavailability enhancer will be administered with INCA033989 at protocol defined dose. | Drug | Cohort 5, Cohort 6, Cohort 7 |
Primary outcome
Pharmacokinetics Parameter: Cmax of INCA33989 following a single SC administration compared with a single IV infusion
Time frame: Up 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 infusion
Time frame: Up 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 infusion
Time frame: Up 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)
Time frame: 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.
8 secondary outcomes
Pharmacokinetics Parameter: tmax of INCA33989 following a single SC administration
Time frame: Up to 12 weeks
Pharmacokinetics Parameter: t1/2 of INCA33989 following a single SC administration
Time frame: Up to 12 weeks
Pharmacokinetics Parameter: CL/F of INCA33989 following a single SC administration
Time frame: Up to 12 weeks
Pharmacokinetics Parameter: Vz/F of INCA33989 following a single SC administration
Time frame: Up to 12 weeks
Pharmacokinetics Parameter: tmax of INCA33989 following a single IV infusion
Time frame: Up to 12 weeks
Pharmacokinetics Parameter: t1/2 of INCA33989 following a single IV infusion
Time frame: Up to 12 weeks
Pharmacokinetics Parameter: CL of INCA33989 following a single IV infusion
Time frame: Up to 12 weeks
Pharmacokinetics Parameter: Vss of INCA33989 following a single IV infusion
Time frame: Up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INCA033989 Following Subcutaneous or Intravenous Administration in Healthy Adult ParticipantsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Healthy Participants
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Incyte Medical Monitor study director
Incyte Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INCA033989 and Bioavailability enhancer in people with Healthy Participants, run by Incyte Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics Parameter: Cmax of INCA33989 following a single SC administration compared with a single IV infusion (time frame: Up to 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.