A Study to Evaluate a Single-Dose Subcutaneous Axatilimab Compared With Intravenous Axatilimab in Healthy Participants
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
72actual
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-01-14 | actual | When the study began enrolling |
| Primary completion | 2025-06-06 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-06-10 | actual | The whole study's end, after follow-up |
| First posted | 2024-12-03 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-06-25 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Healthy Participants
Intervention
- Drug: Axatilimab
Primary outcomes
what the primary-completion date above is the date OFPharmacokinetics Parameter: Cmax of axatilimab
measured 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
measured 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
measured 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)
measured Up to 3 months
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