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A Safety and Tolerability Study of Jaktinib

Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05279001
Collaborator
(none)
26
Enrollment
1
Location
1
Arm
17
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Jaktinib Hydrochloride Tablet
 Phase 1

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
26 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
May 31, 2023
Anticipated Study Completion Date :
Nov 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Jaktinib

Drug: Jaktinib Hydrochloride Tablet
Orally administered, twice a day

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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 Outcome Measures

  1. Efficacy of jaktinib hydrochloride tablets [at least 24 weeks, up to approximately 1 year]

    reduction of spleen volume of ≥35%

  2. Efficacy of jaktinib hydrochloride tablets [at least 24 weeks, up to approximately 1 year]

    reduction of total symptoms score (TSS) of ≥50%

  3. Pharmacokinetic characteristics of jaktinib hydrochloride tablets [7 days]

    Peak Plasma Concentration (Cmax)

  4. Pharmacokinetic characteristics of jaktinib hydrochloride tablets [7 days]

    Time to maximum concentration (Tmax)

  5. Pharmacokinetic characteristics of jaktinib hydrochloride tablets [7 days]

    Half-life (T1/2)

  6. Pharmacokinetic characteristics of jaktinib hydrochloride tablets [7 days]

    Clearance (CL/F)

  7. Pharmacokinetic characteristics of jaktinib hydrochloride tablets [7 days]

    Area under Curve (AUCinf)

  8. Pharmacokinetic characteristics of jaktinib hydrochloride tablets [7 days]

    Volume of distribution

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Site 01 Canton Ohio United States 44718

Sponsors and Collaborators

  • Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier:
NCT05279001
Other Study ID Numbers:
  • ZGJAKUS001
First Posted:
Mar 15, 2022
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Primary Myelofibrosis

Study Results

No Results Posted as of Aug 22, 2022