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Healthy ParticipantsPhase 1NCT06713590

A Study to Evaluate a Single-Dose Subcutaneous Axatilimab Compared With Intravenous Axatilimab in Healthy Participants

A Phase 1 study testing Axatilimab in people with Healthy Participants, run by Incyte Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will be conducted to evaluate a Single-Dose Subcutaneous (SC) Axatilimab Compared With Intravenous Axatilimab in Healthy 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?
Axatilimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteUnited States
Study dates
14 Jan 2025to 10 Jun 2025
Phase
Phase 1
Are there results?
None posted in the registry

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 and willingness to sign a written ICF for the study.
  • Aged 18 to 55 years, inclusive, at the time of signing the ICF.
  • Body mass index within the range of 18.0 to 30.0 kg/m2 (inclusive) at screening.
  • Note: Participants with a BMI up to 32.0 kg/m2 may be enrolled with the sponsor's approval.
  • Body weight of ≥ 40 kg (inclusive). Note: For each cohort, approximately 6 participants from 1 of each weight band (40-65 kg, > 65-90 kg, > 90 kg) will be enrolled, to total approximately 24 participants in each weight band.
  • No clinically significant findings on screening evaluations (clinical, ECG, and comprehensive physical examination, including the eyes). No laboratory values out of normal reference ranges.
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  • Ability to be administered IV or SC study drug.
  • Willingness to avoid pregnancy or fathering children based on the protocol defined criteria below.
  • Male participants with reproductive potential must agree to take appropriate precautions to avoid fathering children, including refraining from donating sperm, from screening through 90 days (a spermatogenesis cycle) after the dose of study drug on Day 1 and must refrain from donating sperm during this period. Permitted methods in preventing pregnancy should be communicated to the participants and their understanding confirmed.
  • Female participants who are WOCBP must have a negative pregnancy test at screening and a negative pregnancy test at check-in (Day -1) and must agree to take appropriate precautions to avoid pregnancy from screening through 60 days (2 menstrual cycles) after the dose of study drug on Day 1 and must refrain from donating oocytes during this period. Permitted methods in preventing pregnancy should be communicated to the participants and their understanding confirmed.
  • Female participants not considered to be of childbearing potential as defined in the protocol are eligible and must have a negative pregnancy test at screening and check-in.

Who cannot join

  • History of uncontrolled or unstable respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.
  • History of cardiovascular, cerebrovascular, peripheral vascular, or thrombotic disease or uncontrolled hypertension.
  • High blood pressure (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg at screening, confirmed by repeat testing).
  • Resting pulse rate < 40 bpm or > 100 bpm at screening. May repeat up to 3 total measurements, separated by 5 minutes, to confirm.
  • History of rheumatologic/autoimmune disorders, except for minor eczema and rosacea.
  • History or presence of an abnormal ECG before initial dose administration that, in the investigator's opinion, is clinically significant. Participants with a QTcF interval > 470 milliseconds, regardless of sex. QRS interval > 120 milliseconds, or PR interval > 220 milliseconds will be excluded. In the event a value is exclusionary, a single ECG will be repeated twice, and an average taken of the 3 readings will be used to determine if a participant should be excluded.
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  • 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, antifungal, or antiviral treatment (includes latent treated tuberculosis).
  • Positive test for HBV, HCV, or HIV. Participants whose results are compatible with prior immunization for or immunity due to infection with HBV may be included at the discretion of the investigator.
  • Any chronic or recurrent edema. History of urticaria, allergic rhinoconjunctivitis, seasonal atopic, food, and/or latex allergy.
  • Medical or self-reported history of alcoholism within 3 months of screening.
  • History of significant alcohol use 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 to 2 units = 125 mL glass of wine).
  • Has received a live vaccine (including attenuated) or anticipation of need for such a vaccine during the study.
  • Note: No vaccines may be administered within 3 months prior to the first dose of study drug.
  • Positive urine or breath test for ethanol or positive urine or serum screen for drugs of abuse that are not otherwise explained by permitted concomitant medications or diet.
  • Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug with another investigational medication or current enrollment in another investigational drug or investigational product study.
  • History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator.
  • Previous receipt of axatilimab.
  • Known hypersensitivity or severe reaction to axatilimab or excipients of axatilimab.
  • Inadequate veins for multiple venous puncture or IV catheter insertion as determined by the investigator or designee.
  • Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator.
  • History of tobacco or nicotine-containing product use within 1 month of screening.
  • Use of prescription drugs (including hormonal contraceptives) within 14 days of study drug administration or nonprescription medications/products (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days of study drug administration. However, occasional and standard-dose acetaminophen, ibuprofen, and standard-dose vitamins are permitted. Megadose vitamins or supplements are not permissible.
  • Women who are pregnant or breastfeeding.
  • Any condition that would, in the investigator's judgment: interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
  • eGFR < 90 mL/min/1.73 m2 based on the site's standard formula at screening. NOTE: assessment of eGFR may be repeated once if outside of the reference range.
  • Excessive exercise beyond the activities of daily living (eg, Ironman®, triathlon, etc) within 7 days before check-in (Day -1).
  • History of keloid or hypertrophic scarring.
  • History of recurrent pneumonia, skin infection, or viral infections within 6 months of screening.
  • History of acute or chronic pancreatitis.
  • History of retinal eye disorders. Presbyopia, myopia, and astigmatism are permitted.
  • Abdominal tattoos, scarring at injection site.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Celerion, Inc

    Tempe, Arizona, 85283

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Randomized Study of Single-Dose Subcutaneous Axatilimab Compared With Intravenous Axatilimab in Healthy Participants

This study will be conducted to evaluate a Single-Dose Subcutaneous (SC) Axatilimab Compared With Intravenous Axatilimab in Healthy Participants.

Being tested
Axatilimab
Keywords
INCA34176, Axatilimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AxatilimabDrug

    Axatilimab will be administered at protocol defined dose.

Study groups in NCT06713590
Study groupRoleWhat they receive
Cohort AExperimentalAxatilimab will be administered at a protocol defined starting dose administered as an IV infusion.
Receives: Drug: Axatilimab
Cohort BExperimentalAxatilimab will be administered at a protocol defined starting dose administered as an SC injection.
Receives: Drug: Axatilimab
Cohort CExperimentalAxatilimab will be administered at a protocol defined starting dose administered as an SC injection.
Receives: Drug: Axatilimab
Cohort DExperimentalAxatilimab will be administered at a protocol defined starting dose administered as an SC injection.
Receives: Drug: Axatilimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetics Parameter: Cmax of axatilimab

    Maximum Observed Plasma Concentration of axatilimab.

    Measured: Pre dose and Post dose on Day 1, Post dose Days 2, 3, 4, 6, 8, 15, 22, 28 and 60

  2. Pharmacokinetics Parameter: AUC(0-t) of axatilimab

    Area Under the concentration- time curve up to the last measurable concentration of axatilimab.

    Measured: Pre dose and Post dose on Day 1, Post dose Days 2, 3, 4, 6, 8, 15, 22, 28 and 60

  3. Pharmacokinetics Parameter: AUC 0-∞ of axatilimab

    Area Under the Concentration-time Curve From 0 to Infinity of axatilimab.

    Measured: Pre dose and Post dose on Day 1, Post dose Days 2, 3, 4, 6, 8, 15, 22, 28 and 60

  4. Number of participants with Treatment Emergent Advers Events (TEAE's)

    Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.

    Measured: Up to 3 months

Secondary outcomes (5)

  1. ADA

    Percent of patients with anti-drug antibody (ADA).

    Measured: Pre dose on Day 1, Post dose Days 8, 15, 22, 28 and 60

  2. Pharmacokinetics Parameter: Tmax of axatilimab

    Time to reach maximum plasma concentration of axatilimab.

    Measured: Pre dose and Post dose on Day 1, Post dose Days 2, 3, 4, 6, 8, 15, 22, 28 and 60

  3. Pharmacokinetics Parameter: t1/2 of axatilima

    Apparent terminal phase disposition half-life of axatilimab.

    Measured: Pre dose and Post dose on Day 1, Post dose Days 2, 3, 4, 6, 8, 15, 22, 28 and 60

  4. Pharmacokinetics Parameter: CL (or CL/F) of axatilimab

    Dose clearance of axatilimab.

    Measured: Pre dose and Post dose on Day 1, Post dose Days 2, 3, 4, 6, 8, 15, 22, 28 and 60

  5. Pharmacokinetics Parameter: Vz (or Vz/F) of axatilimab

    Volume of distribution of axatilimab.

    Measured: Pre dose and Post dose on Day 1, Post dose Days 2, 3, 4, 6, 8, 15, 22, 28 and 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2024
  2. Study start14 Jan 2025
  3. Primary completion6 Jun 2025
  4. Study completion10 Jun 2025

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06713590
Sponsor's protocol ID
INCA034176-102
Status last verified
Jun 2025
First submitted
27 Nov 2024
Last updated
25 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Axatilimab 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 11 inclusion and 35 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: finished, as of the sponsor's last update on 25 Jun 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 axatilimab (time frame: Pre dose and Post dose on Day 1, Post dose Days 2, 3, 4, 6, 8, 15, 22, 28 and 60). 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?

On the ClinicalTrials.gov record for NCT06713590.

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 25 Jun 2025; AzTrials last refreshed its copy on 3 Nov 2026.

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