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/NCT04819620




Registration number
NCT04819620
Ethics application status
Date submitted
24/03/2021
Date registered
29/03/2021
Date last updated
3/10/2022

Titles & IDs
Public title
Pharmacokinetics of PN-232 in Healthy Volunteers
Scientific title
A Randomised, Double-Blind, Placebo-controlled Study of Single and Multiple Ascending Doses of PN-232 in Healthy Volunteers
Secondary ID [1] 0 0
PN-232-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PN-232
Treatment: Drugs - Placebo

Experimental: Single Dose - Single dose administration

Experimental: Multiple Dose - Multiple dose administration

Experimental: Solid Dose Comparison - Solid dose administration


Treatment: Drugs: PN-232
Active Drug

Treatment: Drugs: Placebo
Matching Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety of PN-232
Timepoint [1] 0 0
10 days
Secondary outcome [1] 0 0
Peak concentration of PN-232 in plasma
Timepoint [1] 0 0
10 days
Secondary outcome [2] 0 0
Area under the Concentration (AUC) of PN-232
Timepoint [2] 0 0
10 days

Eligibility
Key inclusion criteria
Key

- Subjects must have BMI between 18 and 32 kg/m2

- Subjects must be non-smokers or social smokers

- Subjects must comply with contraception requirements

- Subjects must be willing to consume meals provided by the clinical center

- Subjects must be willing to attend required clinic visits

- Subjects must be suitable candidates for study procedures

Key
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Subject with a history of clinically significant endocrine, neurological,
cardiovascular, hematological, hepatic, immunological, renal, respiratory,
gastrointestinal or genitourinary abnormalities or diseases within previous 10 years

- Subjects with a history of surgical resection of the stomach, small or large intestine

- Subjects with a fever or symptomatic viral or bacterial infection within 2 weeks of
screening or intestinal infection within 30 days prior to screening

- Subjects with clinically significant laboratory abnormalities

- Subjects with corrected QT greater than 450 msec in males and 470 msec in females

- Subjects who test positive for Hepatitis C or B, or HIV at Screening

- Subjects who cannot refrain from use of prescription and non-prescription drugs and
herbal remedies prior to initial dose of study drug and throughout the study

- Subjects who test positive for drugs of abuse or alcohol at Screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
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
13/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/06/2022
Sample size
Target
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
Protagonist Clinical Site - Adelaide
Recruitment hospital [2] 0 0
Protagonist Study Site - Nedlands
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
6009 - Nedlands

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

Ethics approval
Ethics application status

Summary
Brief summary
This Phase 1 study is designed to determine the safety, tolerability and pharmacokinetics of
PN-232 in healthy volunteers. It is a first-in-human (FIH) study for PN-232 that will be
conducted in three parts. Part 1 is a single ascending dose study, Part 2 is multiple
ascending dose study, and Part 3 is crossover solid dose comparison and effect of food study.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04819620
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/NCT04819620