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

NCT06713590 | Completed Phase 1 FDA Drug

• 1 other identifier: INCA034176-102
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants

Keywords

INCA34176; Axatilimab

Outcome Measures

Primary Outcomes (4)

• Pharmacokinetics Parameter: Cmax of axatilimab

  Maximum Observed Plasma Concentration of axatilimab.

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

• Pharmacokinetics Parameter: AUC(0-t) of axatilimab

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

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

• Pharmacokinetics Parameter: AUC 0-∞ of axatilimab

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

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

• 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.

  Up to 3 months

Secondary Outcomes (5)

• ADA

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

• Pharmacokinetics Parameter: Tmax of axatilimab

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

• Pharmacokinetics Parameter: t1/2 of axatilima

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

• Pharmacokinetics Parameter: CL (or CL/F) of axatilimab

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

• Pharmacokinetics Parameter: Vz (or Vz/F) of axatilimab

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

Study Arms (4)

Cohort A

EXPERIMENTAL

Axatilimab will be administered at a protocol defined starting dose administered as an IV infusion.

Drug: Axatilimab

Cohort B

EXPERIMENTAL

Axatilimab will be administered at a protocol defined starting dose administered as an SC injection.

Drug: Axatilimab

Cohort C

EXPERIMENTAL

Axatilimab will be administered at a protocol defined starting dose administered as an SC injection.

Drug: Axatilimab

Cohort D

EXPERIMENTAL

Axatilimab will be administered at a protocol defined starting dose administered as an SC injection.

Drug: Axatilimab

Interventions

Axatilimab DRUG

Axatilimab will be administered at protocol defined dose.

Cohort A; Cohort B; Cohort C; Cohort D

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (1)

Celerion, Inc

Tempe, Arizona, 85283, United States

Location

Related Links

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

MeSH Terms

Interventions

axatilimab

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 3, 2024
• Study Start: January 14, 2025
• Primary Completion: June 6, 2025
• Study Completion: June 10, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)