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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07153146




Registration number
NCT07153146
Ethics application status
Date submitted
22/08/2025
Date registered
3/09/2025
Date last updated
3/09/2025

Titles & IDs
Public title
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PN-881 in Healthy Subjects.
Scientific title
A Randomized, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of PN-881 in Healthy Subjects
Secondary ID [1] 0 0
PN-881-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PN-881 Oral Solution
Treatment: Drugs - PN-881 Oral Tablet
Treatment: Drugs - Placebo

Experimental: PN-881 Oral Solution Single Ascending Dose - PN-881 Oral Solution Single Ascending Dose

Placebo comparator: Placebo Oral Solution Single Ascending Dose - Placebo single ascending doses

Experimental: PN-881 Oral Solution Multiple Ascending Dose - PN-881 Multiple Ascending Doses

Placebo comparator: Placebo Oral Solution Multiple Ascending Dose - Placebo, multiple ascending doses

Experimental: PN-881 Oral Tablet Single Dose - PN-881 oral tablet single dose

Experimental: PN-881 Oral Tablet Multiple Dose - PN-881 oral tablet multiple dose


Treatment: Drugs: PN-881 Oral Solution
PN-881 Oral Solution

Treatment: Drugs: PN-881 Oral Tablet
PN-881 oral tablet

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

Outcomes
Primary outcome [1] 0 0
Incidence and severity of treatment-emergent adverse events (TEAEs)
Timepoint [1] 0 0
Predose to 7 days after last dose
Secondary outcome [1] 0 0
Maximum observed plasma concentration (Cmax) of PN-881
Timepoint [1] 0 0
48 hours following the first dose and the last dose
Secondary outcome [2] 0 0
Area under the plasma concentration-time curve (AUC) of PN-881
Timepoint [2] 0 0
Predose to 48 hrs after the first and last dose.
Secondary outcome [3] 0 0
Levels of biomarker in serum
Timepoint [3] 0 0
Day 1 Predose up to 48 hrs post (last) dose

Eligibility
Key inclusion criteria
1. Healthy male and female participants of non-childbearing potential, aged 18-65 years inclusive
2. Body mass index (BMI) between 18 and 32 kg/m² (inclusive) at screening
3. Willing and able to comply with all study requirements and provide written informed consent
4. Male participants with female partners of childbearing potential must agree to use highly effective contraception during the study and for 90 days after the last dose
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Clinically significant history or presence of cardiovascular, gastrointestinal, hepatic, renal, neurological, psychiatric, or allergic diseases
2. History of neoplastic disease (except adequately treated non-melanoma skin cancer)
3. Positive test for hepatitis B, hepatitis C, or HIV at screening
4. History of substance abuse or recreational IV drug use within the past 2 years
5. Clinically significant infection or fever (>38°C) within 2 weeks prior to screening
6. Use of any prescription/non-prescription drugs or herbal supplements within 7 days or 5 half-lives before dosing (unless approved by investigator)
7. Supine blood pressure or ECG abnormalities outside protocol-defined ranges
8. Use of tobacco/nicotine products exceeding 5 cigarettes/day or 2 chews/day
9. Consumption of >21 alcohol units/week (males) or >14 units/week (females)

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 analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
8/09/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/06/2026
Actual
Sample size
Target
142
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Clinical Study Director
Address 0 0
Country 0 0
Phone 0 0
+61 1800 243 733
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Phase I study


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07153146