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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04621630




Registration number
NCT04621630
Ethics application status
Date submitted
29/10/2020
Date registered
9/11/2020
Date last updated
18/02/2022

Titles & IDs
Public title
Pharmacokinetics of PN-235 in Healthy Volunteers
Scientific title
A Randomised, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of PN-235 in Healthy Volunteers
Secondary ID [1] 0 0
PN-235-01
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 - PN-235
Treatment: Drugs - Placebo

Experimental: Single Dose - Single dose administration

Experimental: Multiple Dose - Multiple dose administration

Experimental: Solid Dose Comparison - Solid dose administartion


Treatment: Drugs: PN-235
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-235
Timepoint [1] 0 0
10 days
Secondary outcome [1] 0 0
Pharmacokinetics (PK) of PN-235 in plasma
Timepoint [1] 0 0
10 days
Secondary outcome [2] 0 0
Area Under the Concentration (AUC) of PN-235
Timepoint [2] 0 0
10 days

Eligibility
Key inclusion criteria
Key

- Subjects must have BMI between 18 and 32

- 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

Key
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Subject must not have history of clinically significant endocrine, neurological,
cardiovascular, hematological, hepatic, immunological, renal, respiratory,
gastrointestinal or genitourinary abnormalities or diseases within previous 10 years

- Subjects must not have history of surgical resection of the stomach, small or large
intestine

- Subjects must not have fever or symptomatic viral or bacterial infection within 2
weeks of screening

- Subjects must not have corrected QT greater than 450 msec in males and 470 msec in
females

- Subjects must not test positive for Hepatitis C or B at Screening

- Subjects must refrain from use of prescription and non-prescription drugs and herbal
remedies prior to initial dose of study drug and throughout the study

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
12/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/10/2021
Sample size
Target
Accrual to date
Final
107
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Nucleus Network Melbourne Clinic - 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
This Phase 1 study is designed to determine the safety, tolerability and pharmacokinetics of
PN-235 in healthy volunteers. The study 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 a randomized,
crossover solid dose comparison and effect of food study.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04621630
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/NCT04621630