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

NCT04516382 | Completed Phase 1 FDA Drug

• 1 other identifier: PTG-300-07
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Bioavailability of PTG-300

  Bioavailability (area under the plasma-concentration time) of PTG-300 following subcutaneous and intramuscular administration in healthy volunteers

  Week 1

Secondary Outcomes (2)

• Serum Iron Pharmacodynamics of PTG-300

  Week 1

• TSAT Pharmacodynamics of PTG-300

  Week 1

Study Arms (4)

Intravenous

EXPERIMENTAL

PTG-300 Intravenous

Drug: PTG-300

Subcutaneous Low Concentration

EXPERIMENTAL

PTG-300 Subcutaneous Low Concentration

Drug: PTG-300

Subcutaneous High Concentration

EXPERIMENTAL

PTG-300 Subcutaneous High Concentration

Drug: PTG-300

Intramuscular

EXPERIMENTAL

PTG-300 Intramuscular

Drug: PTG-300

Interventions

PTG-300 DRUG

Active drug

Intramuscular; Intravenous; Subcutaneous High Concentration; Subcutaneous Low Concentration

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male volunteers, age 18 to 65 years, inclusive.
• Subjects must have a Body Mass Index (BMI) between 18 and 32 kg/m2 inclusive.
• Subjects must have clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the Investigator.
• Agree to use a barrier method of contraception from Day -2 to 90 days after the last dose of study drug.
• Subjects must have the ability and willingness to attend the necessary visits to the study center.

You may not qualify if:

• History of clinically significant endocrine, neurological, gastrointestinal, cardiovascular, haematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases.
• History of malignancy, with the exception of adequately treated non-melanomatous skin carcinoma.
• Mentally or legally incapacitated, has significant emotional problems at the time of Screening Visit or expected during the conduct of the study, or has a history of a clinically significant psychiatric disorder that would impact the subjects ability to participate in the trial according to the Investigator.
• Fever (body temperature \>38°C) or symptomatic viral or bacterial infection within 2 weeks prior to screening; evidence of intestinal infection within 30 days prior to screening.
• History of severe allergic or anaphylactic reactions.
• A supine blood pressure outside the range of 90 to 139 mm Hg systolic and 50 to 89 mm Hg diastolic, OR heart rate (HR) \>100 beats per minute at Screening and at Day -1.
• Laboratory values that are outside the normal range and considered clinically significant by the Investigator.
• Positive test for hepatitis C antibody, hepatitis B surface antigen or human immunodeficiency virus (HIV) antibody at Screening.
• Subjects considered at high risk of iron deficiency according to the Investigator.
• Subjects with iron deficiency as defined by a ferritin or transferrin saturation below the normal range
• Clinically significant abnormality on ECG performed at the Screening Visit or prior to administration of the initial dose of study drug.
• Corrected QT (QTcF) greater than 450 msec at Screening.
• Subjects with a positive toxicology screening panel.
• Subjects with a history of substance abuse or dependency or history of recreational IV drug use (by self-declaration).
• Consumption of \>14 alcohol units per week (where 1 unit = 284 mL of beer, 25 mL of 40% spirit, or a 125 mL glass of wine).

Sponsors & Collaborators

• Protagonist Therapeutics, Inc.: lead

Study Sites (1)

Protagonist Clinical Center

Melbourne, Australia

Location

Study Officials

• Study Director

  Protagonist Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single group of subjects will sequentially receive PTG-300 as IV, subcutaneous, and intramuscular administration

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 18, 2020
• Study Start: September 14, 2020
• Primary Completion: January 12, 2021
• Study Completion: June 30, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

AU (1)