NCT04516382

Pharmacokinetics and Pharmacodynamics of Different PTG-300 Regimens in Healthy Volunteers

An Open-label Crossover Study Evaluating the Pharmacokinetics and Pharmacodynamics of Different PTG-300 Regimens in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Protagonist Therapeutics, Inc. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

To estimate the bioavailability of PTG-300 following subcutaneous and intramuscular administration in healthy volunteers.

Detailed 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/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 \[TSAT\]).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	PTG-300	Active drug

Timeline

• Start date: 2020-09-14
• Primary completion: 2021-01-12
• Completion: 2021-06-30
• First posted: 2020-08-18
• Last updated: 2021-09-16

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study