TQ05105
DrugTQ05105 is a JAK2 inhibitor.
NCT Number: NCT04339400
TQ05105 is a JAK2 inhibitors and can be used to treat JAK2 target-related diseases. The activation of the JAK/STAT pathway is related to abnormal proliferation, obstruction of apoptosis, and differentiation disorder of leukemia cells which is caused by genetic abnormalities and viral infection.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 1
West China Hospital ,Sichuan University, Chengdu, Sichuan, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
10.No pregnant or breastfeeding women, and a negative pregnancy test. 11.Understood and signed an informed consent form.
Exclusion criteria
TQ05105 is a JAK2 inhibitor.
Time frame: Baseline up to 28 days
DLT defined as any of the events occurring during the study related to drugs.
Time frame: Baseline up to 28 days
MTD defined as the highest dose level at which less than or equal to 2 of 6 subjects experience dose limiting toxicity (DLT).
Time frame: Hour 0, 5, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 11, 24 hours post-dose on single dose; Hour 0 of day 1,day 3,day5, day 6 on multiple dose and hour0, 5, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 11 hours post-dose on multiple dose of day 28.
Cmax is the maximum plasma concentration of TQ05105 or metabolite(s).
Time frame: Hour 0, 5, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 11, 24 hours post-dose on single dose; Hour 0 of day 1,day 3,day5, day 6 on multiple dose and hour0, 5, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 11 hours post-dose on multiple dose of day 28.
To characterize the pharmacokinetics of TQ05105 by assessment of time to reach maximum plasma concentration.
Time frame: Hour 0, 5, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 11, 24 hours post-dose on single dose; Hour 0 of day 1,day 3,day5, day 6 on multiple dose and hour0, 5, 15, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 11 hours post-dose on multiple dose of day 28.
To characterize the pharmacokinetics of TQ05105 by assessment of area under the plasma concentration time curve from zero to infinity.
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Industry
A Single-group, Open-label, Multicenter, Phase I Study of TQ05105 Tablets in Subjects With Myeloproliferative Neoplasms
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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