This study is designed to evaluate the tolerability and safety of HG146 capsule in patients with multiple myeloma.
This study is mainly designed to evaluate the tolerability and safety of HG146 capsule in patients with multiple myeloma. Secondly, to get pharmacokinetic data and preliminary efficacy of HG146 capsule in human. This study adopts the traditional design of "3 + 3" dose escalation. The starting dose is 5 mg and subsequent dose group is respectively for 10, 15 and 20 mg. For each dosing group, subjects are administered orally HG146 every other day for two weeks, followed by one week of rest with 21-day as one treatment cycle. Patients will be treated for 4 cycles or disease progression or unacceptable toxicities, whichever comes first.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
HG146 will be administered every other day for 14 days, followed by 1 week off the drug with each treatment cycle of 21-days.
HitGen Inc
Chengdu, Sichuan, China
Maximum tolerated dose of HG146
To determine the maximum tolerated dose of HG146 in relapsed and refractory multiple myeloma patients.
Time frame: Up to 3 months
Peak Plasma Concentration (Cmax)
To determine the Peak Plasma Concentration of HG146.
Time frame: In cycle 1 (each cycle is 21 days)
Area under the plasma concentration versus time curve (AUC)
To determine the Area under the plasma concentration versus time curve of HG146.
Time frame: In the middle of cycle 1 (each cycle is 21 days)
Time of Peak Concentration (Tmax)
To determine the time of peak concentration of HG146.
Time frame: In the middle of cycle 1 (each cycle is 21 days)
Half life (T1/2)
To determine the half-life of HG146.
Time frame: In the middle of cycle 1 (each cycle is 21 days)
Incidence of adverse events related to treatments
To evaluate the incidence of adverse events that are related to treatments in relapsed and refractory myeloma patients.
Time frame: Up to 21 days after last dose
Incidence of laboratory abnormalities related to treatments
To evaluate the incidence of laboratory abnormalities that are related to treatments in relapsed and refractory myeloma patients.
Time frame: Up to 1 month after last dose
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