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
To estimate the bioavailability of PTG-300 following subcutaneous and intramuscular administration in healthy volunteers.
This is a single center, open-label study in healthy males. Subjects will be screened for eligibility within 28 days of dosing.
Twelve subjects will receive single doses of the following treatments in a fixed sequence:
Treatment A: Intravenous injection of 1.5 mg PTG-300. Treatment B: 40 mg (40 mg/mL) PTG-300 administered subcutaneously. Treatment C: 40 mg (200 mg/mL) PTG-300 administered subcutaneously. Treatment D: 40 mg (40 mg/mL) PTG-300 administered intramuscularly.
There will be a washout period of at least 7 days between Treatment A and Treatment B and at least 12 days between Treatments B, C, and D.
Subjects' safety will be monitored, and blood samples will be collected for pharmacokinetics and pharmacodynamics (serum iron, serum ferritin, serum transferrin, and transferrin saturation [TSAT]).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous | Experimental | PTG-300 Intravenous |
|
| Subcutaneous Low Concentration | Experimental | PTG-300 Subcutaneous Low Concentration |
|
| Subcutaneous High Concentration | Experimental | PTG-300 Subcutaneous High Concentration |
|
| Intramuscular | Experimental | PTG-300 Intramuscular |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTG-300 | Drug | Active drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bioavailability of PTG-300 | Bioavailability (area under the plasma-concentration time) of PTG-300 following subcutaneous and intramuscular administration in healthy volunteers | Week 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Iron Pharmacodynamics of PTG-300 | Change from baseline in serum iron following subcutaneous and intramuscular administration in healthy volunteers | Week 1 |
| TSAT Pharmacodynamics of PTG-300 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
male
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Protagonist Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Protagonist Clinical Center | Melbourne | Australia |
Not provided
Single group of subjects will sequentially receive PTG-300 as IV, subcutaneous, and intramuscular administration
Not provided
Not provided
Not provided
Not provided
Change from baseline in transferrin saturation (TSAT) following subcutaneous and intramuscular administration in healthy volunteers
| Week 1 |