A Safety and Tolerability Study of Jaktinib

Z

Zelgen Biopharmaceuticals

Status and phase

Enrolling
Phase 1

Conditions

Myelofibrosis

Treatments

Drug: Jaktinib Hydrochloride Tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT05279001
ZGJAKUS001

Details and patient eligibility

About

This research study is studying a drug called Jaktinib as a possible treatment for Myelofibrosis.

Full description

This study is a Phase 1, single-arm, open-label, dose escalation trial, to evaluate the safety and tolerability of Jaktinib in patients with PMF or Post-PV/ET MF and who are relapsed/refractory to a marketed JAK inhibitor

Enrollment

26 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of myelofibrosis (primary, post-polycythemia vera, or post-essential thrombocythemia).
  • Relapsed/refractory to a marketed (FDA approved) JAK inhibitor.
  • At least 18 years of age.
  • ECOG PS 0, 1, or 2.
  • Expected life expectancy is greater than 24 weeks.

Exclusion criteria

  • Any chemotherapy, immunomodulatory therapy, immunosuppressive therapy, corticosteroids, or growth factor treatment within 14 days prior to initiation of study drug.
  • Major surgery or radiation therapy within 28 days prior to initiation of study drug.
  • With suspected allergies to jaktinib or its excipient.
  • Another clinical trial of a new drug or medical instrument within 3 months before screening.
  • Females who are pregnant, currently breastfeeding, planning to become pregnant.
  • Unable to adopt effective contraceptive methods during the study.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

26 participants in 1 patient group

Jaktinib
Experimental group
Treatment:
Drug: Jaktinib Hydrochloride Tablet

Trial contacts and locations

1

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Central trial contact

Jason Wu, M.D

Data sourced from clinicaltrials.gov

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