A Safety and Tolerability Study of Jaktinib

A Phase 1 Dose Escalation, Safety and Tolerability Study of Jaktinib in Patients With Primary Myelofibrosis (PMF) or Post-polycythemia Vera/Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF) and Who Are Relapsed/ Refractory to a Marketed JAK Inhibitor

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05279001

Enrollment

Registered

2022-03-15

Start date

2024-07-01

Completion date

2025-11-30

Last updated

2024-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelofibrosis

Brief summary

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

Detailed 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

Interventions

DRUGJaktinib Hydrochloride Tablet

Orally administered, twice a day

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Safety of jaktinib hydrochloride tablets	At least 24 weeks, up to approximately 1 year for follow-up	Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Dose-limiting toxicities (DLTs) of jaktinib hydrochloride tablets	28 days	Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

Secondary

Measure	Time frame	Description
Efficacy of jaktinib hydrochloride tablets	at least 24 weeks, up to approximately 1 year	reduction of spleen volume of ≥35%
Pharmacokinetic characteristics of jaktinib hydrochloride tablets	7 days	Peak Plasma Concentration (Cmax)

Countries

United States

Contacts

Primary ContactJason Wu, M.D

wujs@zelgen.com+86-21-58942758

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026