Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04516382




Registration number
NCT04516382
Ethics application status
Date submitted
10/08/2020
Date registered
18/08/2020
Date last updated
16/09/2021

Titles & IDs
Public title
Pharmacokinetics and Pharmacodynamics of Different PTG-300 Regimens in Healthy Volunteers
Scientific title
An Open-label Crossover Study Evaluating the Pharmacokinetics and Pharmacodynamics of Different PTG-300 Regimens in Healthy Volunteers
Secondary ID [1] 0 0
PTG-300-07
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PTG-300

Experimental: Intravenous - PTG-300 Intravenous

Experimental: Subcutaneous Low Concentration - PTG-300 Subcutaneous Low Concentration

Experimental: Subcutaneous High Concentration - PTG-300 Subcutaneous High Concentration

Experimental: Intramuscular - PTG-300 Intramuscular


Treatment: Drugs: PTG-300
Active drug
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Bioavailability of PTG-300
Timepoint [1] 0 0
Week 1
Secondary outcome [1] 0 0
Serum Iron Pharmacodynamics of PTG-300
Timepoint [1] 0 0
Week 1
Secondary outcome [2] 0 0
TSAT Pharmacodynamics of PTG-300
Timepoint [2] 0 0
Week 1

Eligibility
Key inclusion criteria
1. Healthy male volunteers, age 18 to 65 years, inclusive.

2. Subjects must have a Body Mass Index (BMI) between 18 and 32 kg/m2 inclusive.

3. Subjects must have clinical laboratory values within normal range as specified by the
testing laboratory, unless deemed not clinically significant by the Investigator.

4. Agree to use a barrier method of contraception from Day -2 to 90 days after the last
dose of study drug.

5. Subjects must have the ability and willingness to attend the necessary visits to the
study center.
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of clinically significant endocrine, neurological, gastrointestinal,
cardiovascular, haematological, hepatic, immunological, renal, respiratory, or
genitourinary abnormalities or diseases.

2. History of malignancy, with the exception of adequately treated non-melanomatous skin
carcinoma.

3. 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.

4. 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.

5. History of severe allergic or anaphylactic reactions.

6. 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.

7. Laboratory values that are outside the normal range and considered clinically
significant by the Investigator.

8. Positive test for hepatitis C antibody, hepatitis B surface antigen or human
immunodeficiency virus (HIV) antibody at Screening.

9. Subjects considered at high risk of iron deficiency according to the Investigator.

10. Subjects with iron deficiency as defined by a ferritin or transferrin saturation below
the normal range

11. Clinically significant abnormality on ECG performed at the Screening Visit or prior to
administration of the initial dose of study drug.

12. Corrected QT (QTcF) greater than 450 msec at Screening.

13. Subjects with a positive toxicology screening panel.

14. Subjects with a history of substance abuse or dependency or history of recreational IV
drug use (by self-declaration).

15. 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).

16. 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.

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2021
Sample size
Target
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Protagonist Clinical Center - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Protagonist Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To estimate the bioavailability of PTG-300 following subcutaneous and intramuscular
administration in healthy volunteers.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04516382
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Protagonist Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04516382