Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will be conducted to evaluate a Single-Dose Subcutaneous (SC) Axatilimab Compared With Intravenous Axatilimab in Healthy Participants.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | Axatilimab will be administered at a protocol defined starting dose administered as an IV infusion. |
|
| Cohort B | Experimental | Axatilimab will be administered at a protocol defined starting dose administered as an SC injection. |
|
| Cohort C | Experimental | Axatilimab will be administered at a protocol defined starting dose administered as an SC injection. |
|
| Cohort D | Experimental | Axatilimab will be administered at a protocol defined starting dose administered as an SC injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Axatilimab | Drug | Axatilimab will be administered at protocol defined dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ADA | Percent of patients with anti-drug antibody (ADA). | Pre dose on Day 1, Post dose Days 8, 15, 22, 28 and 60 |
| Pharmacokinetics Parameter: Tmax of axatilimab | Time to reach maximum plasma concentration of axatilimab. |
Not provided
Inclusion Criteria:
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.
Exclusion Criteria:
Note: No vaccines may be administered within 3 months prior to the first dose of study drug.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Incyte Medical Monitor | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion, Inc | Tempe | Arizona | 85283 | United States |
Not provided
| Label | URL |
|---|---|
| A Study to Evaluate a Single-Dose Subcutaneous Axatilimab Compared With Intravenous Axatilimab in Healthy Participants | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000711669 | axatilimab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | Apparent terminal phase disposition half-life 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: CL (or CL/F) of axatilimab | Dose clearance 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 | Volume of distribution of axatilimab. | Pre dose and Post dose on Day 1, Post dose Days 2, 3, 4, 6, 8, 15, 22, 28 and 60 |