Recent Updates
Recently added Catalysts

PN-881

Phase 1

Undisclosed | Small molecule | Other |Protagonist Therapeutics, Inc.|Trials Updated: Aug 5, 2026

PN-881 target and mechanism

Molecular targetIL-17
Target classCytokine
ModalitySmall molecule

Also known as PN-881 Oral Solution

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment146

FDA Designations

No designations recorded

PN-881 clinical trials

PN-881 · 1 trial · 1 indication

Phase 1 1
NCT07153146Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PN-881 in Healthy Subjects.Healthy Volunteer
COMPLETED146 Analytics
PHASE1COMPLETED
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PN-881 in Healthy Subjects.
Healthy VolunteerUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence and severity of treatment-emergent adverse events (TEAEs)
Predose to 7 days after last dose

Evaluate the safety and tolerability of PN-881 in comparison to placebo after single and multiple doses in healthy subjects assessed for severity, seriousness, and relation to the investigational product.

Secondary Endpoints

Maximum observed plasma concentration (Cmax) of PN-881
48 hours following the first dose and the last dose
Area under the plasma concentration-time curve (AUC) of PN-881
Predose to 48 hours after the first and last dose.
Levels of biomarker in serum
Day 1 Predose up to 48 hours post (last) dose
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PN-881 Oral Solution Single Ascending DoseEXPERIMENTALPN-881 Oral Solution Single Ascending Dose
Placebo Oral Solution Single Ascending DosePLACEBO_COMPARATORPlacebo single ascending doses
PN-881 Oral Solution Multiple Ascending DoseEXPERIMENTALPN-881 Multiple Ascending Doses
Placebo Oral Solution Multiple Ascending DosePLACEBO_COMPARATORPlacebo, multiple ascending doses
PN-881 Oral Tablet Single DoseEXPERIMENTALPN-881 oral tablet single dose
PN-881 Oral Tablet Multiple DoseEXPERIMENTALPN-881 oral tablet multiple dose

Interventions

NameTypeDescription
PN-881 Oral SolutionDRUGPN-881 Oral Solution
PN-881 Oral TabletDRUGPN-881 oral tablet
PlaceboDRUGPlacebo
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 part...

Countries:Australia
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

MEDIUMSep 5, 2026NCT07153146TRIAL_REMOVED: changed
MEDIUMSep 5, 2026NCT07153146TRIAL_REMOVED: changed
MEDIUMSep 5, 2026NCT07153146TRIAL_REMOVED: changed
MEDIUMSep 5, 2026NCT07153146TRIAL_REMOVED: changed
HIGHAug 5, 2026NCT07153146Status: RECRUITING → COMPLETED

Frequently asked questions about PN-881

What is PN-881?

PN-881 is an investigational small molecule drug developed by Protagonist Therapeutics, Inc. It is an orally administered compound, also referred to as PN-881 Oral Solution, and has been studied in a Phase 1 clinical trial in healthy volunteers. Its therapeutic indications have not been disclosed.

What does PN-881 target?

PN-881 targets IL-17, a cytokine. As a small molecule directed at this cytokine target, it is being developed as an oral therapy. The IL-17 pathway is the molecular target named for this investigational compound.

Who makes PN-881?

PN-881 is developed by Protagonist Therapeutics, Inc., which trades under the ticker PTGX. The company is the sponsor of the clinical program for this oral small molecule.

What phase is PN-881 in?

PN-881 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed for this drug.

What clinical trials is PN-881 in?

PN-881 has been evaluated in a single Phase 1 trial, NCT07153146, titled Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PN-881 in Healthy Subjects. The trial was completed, enrolled 146 participants, was randomized, double-blind, and placebo-controlled, and was conducted in Australia.

Is PN-881 the same as PN-881 Oral Solution?

Yes, PN-881 Oral Solution is another name for PN-881. Both refer to the same investigational small molecule developed by Protagonist Therapeutics, Inc.