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Study to Evaluate Safety, Pharmacokinetic and Pharmacodynamic Dose Escalation and Expansion Study of PXS-5505 in Patients With Primary, Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis

NCT04676529 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2025-08-24

No results posted yet for this study

Summary

This study will be an open-label phase 1/2a study to evaluate the safety and tolerability of PXS-5505 in patients with primary, postpolycythemia vera (PV) or post-essential thrombocythemia (ET) myelofibrosis.

Conditions

Interventions

DRUG

PXS-5505

PXS-5505 is a hard capsule (size 0) with the additional excipients mannitol and magnesium stearate.

Sponsors & Collaborators

  • Syntara

    lead INDUSTRY

Principal Investigators

  • Jana Baskar, MBBS MMedSc MBA · Syntara

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-18
Primary Completion
2025-07-09
Completion
2025-07-09
FDA Drug
Yes

Countries

  • United States
  • Australia
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04676529 on ClinicalTrials.gov