Status:
COMPLETED
Pharmacokinetics and Pharmacodynamics of Different PTG-300 Regimens in Healthy Volunteers
Lead Sponsor:
Protagonist Therapeutics, Inc.
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-65 years
Phase:
PHASE1
Brief 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 i...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
- Unable to refrain from or anticipates the use of any medications, including prescription and non-prescription drugs and herbal remedies (such as St. John's Wort \[Hypericum perforatum\]), beginning 14 days (or 5 half lives, whichever is longer) before administration of the initial dose of study drug and continuing throughout the study until the final study visit.
Key Trial Info
Start Date :
September 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04516382
Start Date
September 14 2020
End Date
June 30 2021
Last Update
September 16 2021
Active Locations (1)
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1
Protagonist Clinical Center
Melbourne, Australia