Pharmacokinetics and Pharmacodynamics of Different PTG-300 Regimens in Healthy Volunteers
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Healthy Volunteers
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Single group of subjects will sequentially receive PTG-300 as IV, subcutaneous, and intramuscular administrationMasking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Only males
Description
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/m...
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]).
Tracking Information
- NCT #
- NCT04516382
- Collaborators
- Not Provided
- Investigators
- Study Director: Study Director Protagonist Therapeutics, Inc.
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