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Short-term Clinical Study of CN128 in Thalassemia Patients

Primary Purpose

Thalassemia

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CN128 Tablets
Sponsored by
Hangzhou Zede Pharma-Tech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thalassemia

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Subject inclusion criteria:

  • Thalassemia patients with serum ferritin ≥ 500 µg/L
  • Patients aged 16 and above
  • HB≥80 g/L before administration
  • Voluntarily participate in the experiment, and the process of obtaining informed consent met the requirements of GCP.

Subject exclusion criteria:

  • Hepatitis B surface antigen positive, hepatitis B core antibody positive and HBV-DNA positive, hepatitis C anti-HCV positive, HIV positive, Treponema pallidum positive
  • History of active digestive tract diseases (including gastric ulcer, duodenal ulcer, gastroesophageal varices, ulcerative colitis, Crohn's disease, digestive tract tumors, familial genetic polyps), history of digestive tract perforation, history of digestive tract surgery and influence on drug absorption, and other investigators believe that patients with potential intestinal complications
  • Liver dysfunction (ALT or AST > 2.5×ULN); or renal dysfunction (serum creatinine > 1.5×ULN)
  • Uncontrolled active infections
  • Patients currently taking CYP3A strong inducer or inhibitor drugs or drugs that may prolong the QT interval without temporary suspension of use or temporary substitution of the said drugs
  • Allergic constitution: allergic to or with contraindication of main ingredients or excipients of CN128 tablets (microcrystalline cellulose, cross-linked sodium carboxymethyl cellulose, silica, sodium stearate fumarate, Opadry)
  • Patients who have abnormal ECG with clinical significance: congenital long QT syndrome or known family history of long QT syndrome; QTc > 450ms (male) or QTc > 470ms (female); patients who have ventricular or atrial tachyarrhythmia with clinical significance, etc
  • Family planning participants (including male subjects) during or within three months after the trial
  • Patients with a history of blood donation within 3 months before the trial
  • Patients with a history of smoking (more than 5 cigarettes or products with equivalent nicotine per day), alcoholism (more than 14 units of alcohol per week: 1 alcohol unit equals 10 mL or 8 g pure alcohol; 25 mL 40% liquor, 330 mL 5% beer, 175 mL 12% red wine equals 1.0, 1.5, 2.0 alcohol units respectively), drug abuse and addiction history
  • Patients who smoke, drink or eat any food containing alcohol, xanthine or grapefruit (including chocolate, tea, coffee or cola drinks) within 48 h before using of test drug
  • The subjects should not join in other clinical drug or instrument study or some other clinical studies within 3 months before taking the study drug, except for non interventional studies;
  • Patients with positive results of nicotine and urine drug screening
  • Patients with difficulty in venous blood collection
  • Patients with positive blood pregnancy test results
  • Any patient with conditions which the investigators resume inappropriate to participate in this study, such as: poor health status, poor compliance, unwillingness or inability to comply with treatment regimens, including delayed visits

Sites / Locations

  • The first affiliated hospital, Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

First Dosage

Second Dosage

Arm Description

The dose of CN128 is 20 mg/kg bw, bid.

The dose of CN128 is 15 mg/kg bw, bid.

Outcomes

Primary Outcome Measures

Height (Unit: m)
The patient's height will be determined, and it's one kind of Physical examination.
Weight (Unit: kg)
The patient's weight will be determined, and it's one kind of Physical examination.
Generally Phisical examination
The patient's skin, neck, eyes, ears, nose, throat, chest, back, lymph nodes, arms, legs, nervous system, etc. will be observed, and it's one kind of Physical examination.
Pulse (Unit: bpm)
The patient's pulse will be determined, and it's one kind of vital signs checks.
Respiration (Unit: bpm)
The patient's respiration will be determined, and it's one kind of vital signs checks.
Blood pressure (Unit: mmHg)
Both patient's systolic and diastolic blood pressure will be measured, and it's one kind of vital signs checks.
Temperature (Unit: ℃)
The patient's temperature will be determined, and it's one kind of vital signs checks.
Electrocardiogram: P-R (Unit: ms), QRS (Unit: ms), QTc (Unit: ms), etc
The patient's electrocardiogram will be measured, and it's one kind of laboratory test.
WBC (Unit: 10E9/L), RBC (Unit: 10E9/L), NEUT (Unit: 10E9/L), BASO (Unit: 10E9/L)
The patient's blood examination(WBC (Unit: 10E9/L), RBC (Unit: 10E9/L), NEUT (Unit: 10E9/L), BASO (Unit: 10E9/L), etc.)will be determined at Day 3, Day 7, Day 11 respectively, and it's one kind of laboratory test.
ALT (Unit: U/L), AST (Unit: U/L)
The patient's blood biochemical examination(ALT (Unit: U/L), AST (Unit: U/L), etc.)will be determined at Day 3, Day 7, Day 11 respectively,and it's one kind of laboratory test.
Fibrinogen (Unit: g/L), Prothrombin time (Unit: s), APTT (Unit: s)
The patient's blood coagulation function ( fibrinogen (Unit: g/L), prothrombin time (Unit: s), APTT (Unit: s) , etc.) will be determined at Day 11, and it's one kind of laboratory test.
Serum iron (Unit: umol/L)
The patient's serum iron will be determined at Day 11, and it's one kind of laboratory test.
Urine colour
The colour of urine will be observed at Day 3, Day 7, Day 11 respectively,and it's one kind of laboratory test.
Urine appearance
The appearance of urine will be observed at Day 3, Day 7, Day 11 respectively,and it's one kind of laboratory test.
Urine glucose (Unit: mmol/L)
The glucose of urine will be determined at Day 3, Day 7, Day 11 respectively,and it's one kind of laboratory test.
Urine protein (Unit: g/L)
The protein of urine will be determined at Day 3, Day 7, Day 11 respectively,and it's one kind of laboratory test.
Number of subjects with adverse events
It's the number of subjects with adverse events after administration.
AUC0-t of CN128
Pharmacokinetics parameters
AUC0-∞ of CN128
Pharmacokinetics parameters
Cmax of CN128
Pharmacokinetics parameters
Tmax of CN128
Pharmacokinetics parameters
t1/2 of CN128
Pharmacokinetics parameters
CL/F of CN128
Pharmacokinetics parameters
Vd/F of CN128
Pharmacokinetics parameters
MRT of CN128
Pharmacokinetics parameters
Css-av of CN128
Pharmacokinetics parameters
Css-min of CN128
Pharmacokinetics parameters
Css-max of CN128
Pharmacokinetics parameters
Accumulation rate of CN128
Pharmacokinetics parameters
Fluctuation index of CN128
Pharmacokinetics parameters
λz of CN128
Pharmacokinetics parameters

Secondary Outcome Measures

Full Information

First Posted
April 18, 2019
Last Updated
June 8, 2023
Sponsor
Hangzhou Zede Pharma-Tech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03935633
Brief Title
Short-term Clinical Study of CN128 in Thalassemia Patients
Official Title
Phase Ib Clinical Study to Assess the Safety, Tolerability and Pharmacokinetic Parameters of CN128 Tablets to Administration in Thalassemia Patients Aged 16 and Above
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
May 6, 2019 (Actual)
Study Completion Date
December 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hangzhou Zede Pharma-Tech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Primary objectives: To study the tolerance and safety of multiple oral administration of CN128 in patients with thalassemia aged 16 years and above. To study the pharmacokinetics of CN128 in thalassemia patients aged 16 and above by multiple oral administrations of CN128 Design: The study is designed as a safety, tolerability and pharmacokinetic parameters study, phase Ib trial. The study is consisted of: multiple dose tolerance and safety study; multiple administration pharmacokinetics. Subject inclusion criteria: Thalassemia patients with serum ferritin ≥ 500 µg/L Patients aged 16 and above HB≥80 g/L before administration Voluntarily participate in the experiment, and the process of obtaining informed consent met the requirements of GCP. Subject exclusion criteria: Hepatitis B surface antigen positive, hepatitis B core antibody positive and HBV-DNA positive, hepatitis C anti-HCV positive, HIV positive, Treponema pallidum positive History of active digestive tract diseases (including gastric ulcer, duodenal ulcer, gastroesophageal varices, ulcerative colitis, Crohn's disease, digestive tract tumors, familial genetic polyps), history of digestive tract perforation, history of digestive tract surgery and influence on drug absorption, and other investigators believe that patients with potential intestinal complications Liver dysfunction (ALT or AST > 2.5×ULN); or renal dysfunction (serum creatinine > 1.5×ULN) Uncontrolled active infections Patients currently taking CYP3A strong inducer or inhibitor drugs or drugs that may prolong the QT interval without temporary suspension of use or temporary substitution of the said drugs ect. Usage: All subjects fasted prior to administration of study drug using 240 ml warm water. The people can not drink water within 1h before administration. Pharmacokinetic assessment of CN128 administration: PK parameters of CN128 include AUC 0-t, AUC 0-∞, Cmax, Tmax, t1/2, CL/F, Vd/ F, MRT, λz, Css-av, Css-min, Css-max, Accumulation rate, Fluctuation index, etc. Safety and tolerability assessments: Evaluation was based on the incidence rate of adverse events (AE) after the administration, study termination information, vital signs, physical examination, laboratory tests and ECG. Statistics
Detailed Description
Primary objectives: To study the tolerance and safety of multiple oral administration of CN128 in patients with thalassemia aged 16 years and above. To study the pharmacokinetics of CN128 in thalassemia patients aged 16 and above by multiple oral administrations of CN128 Design: The study is designed as a safety, tolerability and pharmacokinetic parameters study, phase Ib trial. The study is consisted of: • Multiple dose tolerance and safety study: The trial will start with the lower dose of CN128 given to 8 subjects (20 mg/kg body weight [bw], bid).The dose of second group is 15 mg/kg bw, bid (n=8). • Multiple administration pharmacokinetics: AUC 0-t, AUC 0-∞, Cmax, Tmax, t1/2, CL/F, Vd/ F, MRT, λz, Css-av, Css-min, Css-max, Accumulation rate, Fluctuation index, etc. Subject inclusion criteria: Thalassemia patients with serum ferritin ≥ 500 µg/L Patients aged 16 and above HB≥80 g/L before administration Voluntarily participate in the experiment, and the process of obtaining informed consent met the requirements of GCP. Subject exclusion criteria: Hepatitis B surface antigen positive, hepatitis B core antibody positive and HBV-DNA positive, hepatitis C anti-HCV positive, HIV positive, Treponema pallidum positive History of active digestive tract diseases (including gastric ulcer, duodenal ulcer, gastroesophageal varices, ulcerative colitis, Crohn's disease, digestive tract tumors, familial genetic polyps), history of digestive tract perforation, history of digestive tract surgery and influence on drug absorption, and other investigators believe that patients with potential intestinal complications Liver dysfunction (ALT or AST > 2.5×ULN); or renal dysfunction (serum creatinine > 1.5×ULN) Uncontrolled active infections Patients currently taking CYP3A strong inducer or inhibitor drugs or drugs that may prolong the QT interval without temporary suspension of use or temporary substitution of the said drugs Allergic constitution: allergic to or with contraindication of main ingredients or excipients of CN128 tablets (microcrystalline cellulose, cross-linked sodium carboxymethyl cellulose, silica, sodium stearate fumarate, Opadry) Patients who have abnormal ECG with clinical significance: congenital long QT syndrome or known family history of long QT syndrome; QTc > 450ms (male) or QTc > 470ms (female); patients who have ventricular or atrial tachyarrhythmia with clinical significance, etc Family planning participants (including male subjects) during or within three months after the trial Patients with a history of blood donation within 3 months before the trial Patients with a history of smoking (more than 5 cigarettes or products with equivalent nicotine per day), alcoholism (more than 14 units of alcohol per week: 1 alcohol unit equals 10 mL or 8 g pure alcohol; 25 mL 40% liquor, 330 mL 5% beer, 175 mL 12% red wine equals 1.0, 1.5, 2.0 alcohol units respectively), drug abuse and addiction history Patients who smoke, drink or eat any food containing alcohol, xanthine or grapefruit (including chocolate, tea, coffee or cola drinks) within 48 h before using of test drug The subjects should not join in other clinical drug or instrument study or some other clinical studies within 3 months before taking the study drug, except for non interventional studies; Patients with positive results of nicotine and urine drug screening Patients with difficulty in venous blood collection Patients with positive blood pregnancy test results Any patient with conditions which the investigators resume inappropriate to participate in this study, such as: poor health status, poor compliance, unwillingness or inability to comply with treatment regimens, including delayed visits Usage: Subjects started fasting for solid from 21:00 on the day before the study and for liquid within 1 h before and after the administration. Subjects in each dose group received a single administration on the first day of the study on an empty stomach. Blood samples were collected at different time points before and within 48 hours after the administration (before the administration on day 3). No administration was conducted on day 2. continuous administration was conducted from day 3 to day 8, twice a day, once in the morning on an empty stomach, once in 12 hours (±15min). The valley concentration blood samples were collected in the morning on day 6, 7 and 8. In the morning of day 9, a single administration was conducted on an empty stomach. Blood samples were taken at the different time points before and within 48 hours after the administration on day 9. Each dose was taken with 240 mL warm water.Except for the water taken together with the tablets, it should be ensured that the water was banned for 1 hour before and after the valley concentration blood sample collection from day 6 to day 8 and 1 hour before and after the administration in the morning on day 1 and day 9. Pharmacokinetic assessment of CN128 administration: PK parameters of CN128 include AUC 0-t, AUC 0-∞, Cmax, Tmax, t1/2, CL/F, Vd/ F, MRT, λz, Css-av, Css-min, Css-max, Accumulation rate, Fluctuation index, etc. Safety and tolerability assessments: Evaluation was based on the incidence rate of adverse events (AE) after the administration, study termination information, vital signs (including body temperature, pulse, breathing, sitting blood pressure) and physical examination (including height, weight, general condition, skin, neck (including thyroid), eyes, ears, nose, throat, chest, abdomen, back, lymph nodes, limbs and nervous system examinations, and laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function, serum iron, thyroid gland and parathyroid gland function), ECG to evaluate the status. Statistics: Pharmacokinetic analysis: Phoenix WinNonlin software (Pharsight Corporation, version 7.0) was used to estimate and analyze the parameters of PK in non-atrioventricular model according to dosage. The pharmacokinetic parameters were calculated in real time to fully reflect the characteristics of drug absorption, distribution, metabolism and excretion in human body. The PK parameters of each participant were calculated according to the following methods. PK parameters include: AUC0-t, AUC0-∞, Cmax, Tmax, t1/2, CL/F, Vd/F, MRT, λz, Css_av, Css_min, Css_max, Accumulation rate and Fluctuation index. Descriptive statistics were summarized on untransformed datas of drug concentration in plasma at each time point: AUC0 t, AUC0-∞, Cmax, Tmax, t1/2, CL/F, Vd/F, MRTλz, Css_av, Css_min, Css_max, R and DF. Descriptive statistics was used in the analysis of Number (N), arithmetic mean, geometric mean, standard deviation (SD), CV, minimum, median and maximum. Average and individual time-concentration curves were drawn according to the study group. • Safety analysis All AE, treatment emergent adverse events (TEAE), drug-related TEAE, grade 3 or above TEAE, serious adverse events (SAE), drug-related SAE, TEAE leading to death, TEAE leading to termination of trial, drug-relation TEAE leading to termination of trial and drug-related TEAE leading to discontinuation of use of test drug were summarized for case number, subject number and incidence rate. P value for the incidence of these AEs with different classifications was calculated by Fisher's exact test. TEAE, SAE, drug-related TEAE, drug-related SAE, TEAE leading to the termination of the trial, and TEAE leading to the discontinuation of drug use were summarized and described according to the system organ classification (SOC), preferred terminology (PT) and study group. The severity of TEAE and drug-related TEAE was also summarized according to SOC, PT and study groups. The measured value of parameters and changes from baseline of vital signs, 12-lead ECG, physical examination, clinical laboratory examination, etc. were summarized according to the planned time point and the study group. Determine dose-limited toxicity of multiple dose in human (DLT); Determine the maximum tolerable dose of multiple dose in human (MTD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thalassemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
First Dosage
Arm Type
Experimental
Arm Description
The dose of CN128 is 20 mg/kg bw, bid.
Arm Title
Second Dosage
Arm Type
Experimental
Arm Description
The dose of CN128 is 15 mg/kg bw, bid.
Intervention Type
Drug
Intervention Name(s)
CN128 Tablets
Intervention Description
Iron chelator, oral tablets
Primary Outcome Measure Information:
Title
Height (Unit: m)
Description
The patient's height will be determined, and it's one kind of Physical examination.
Time Frame
Day 11
Title
Weight (Unit: kg)
Description
The patient's weight will be determined, and it's one kind of Physical examination.
Time Frame
Day 11
Title
Generally Phisical examination
Description
The patient's skin, neck, eyes, ears, nose, throat, chest, back, lymph nodes, arms, legs, nervous system, etc. will be observed, and it's one kind of Physical examination.
Time Frame
Day 11
Title
Pulse (Unit: bpm)
Description
The patient's pulse will be determined, and it's one kind of vital signs checks.
Time Frame
Day 1 to Day 11
Title
Respiration (Unit: bpm)
Description
The patient's respiration will be determined, and it's one kind of vital signs checks.
Time Frame
Day 1 to Day 11
Title
Blood pressure (Unit: mmHg)
Description
Both patient's systolic and diastolic blood pressure will be measured, and it's one kind of vital signs checks.
Time Frame
Day 1 to Day 11
Title
Temperature (Unit: ℃)
Description
The patient's temperature will be determined, and it's one kind of vital signs checks.
Time Frame
Day 1 to Day 11
Title
Electrocardiogram: P-R (Unit: ms), QRS (Unit: ms), QTc (Unit: ms), etc
Description
The patient's electrocardiogram will be measured, and it's one kind of laboratory test.
Time Frame
Day 1 to Day 11
Title
WBC (Unit: 10E9/L), RBC (Unit: 10E9/L), NEUT (Unit: 10E9/L), BASO (Unit: 10E9/L)
Description
The patient's blood examination(WBC (Unit: 10E9/L), RBC (Unit: 10E9/L), NEUT (Unit: 10E9/L), BASO (Unit: 10E9/L), etc.)will be determined at Day 3, Day 7, Day 11 respectively, and it's one kind of laboratory test.
Time Frame
Day 3, Day 7, Day 11
Title
ALT (Unit: U/L), AST (Unit: U/L)
Description
The patient's blood biochemical examination(ALT (Unit: U/L), AST (Unit: U/L), etc.)will be determined at Day 3, Day 7, Day 11 respectively,and it's one kind of laboratory test.
Time Frame
Day 3, Day 7, Day 11
Title
Fibrinogen (Unit: g/L), Prothrombin time (Unit: s), APTT (Unit: s)
Description
The patient's blood coagulation function ( fibrinogen (Unit: g/L), prothrombin time (Unit: s), APTT (Unit: s) , etc.) will be determined at Day 11, and it's one kind of laboratory test.
Time Frame
Day 11
Title
Serum iron (Unit: umol/L)
Description
The patient's serum iron will be determined at Day 11, and it's one kind of laboratory test.
Time Frame
Day 11
Title
Urine colour
Description
The colour of urine will be observed at Day 3, Day 7, Day 11 respectively,and it's one kind of laboratory test.
Time Frame
Day 3, Day 7, Day 11
Title
Urine appearance
Description
The appearance of urine will be observed at Day 3, Day 7, Day 11 respectively,and it's one kind of laboratory test.
Time Frame
Day 3, Day 7, Day 11
Title
Urine glucose (Unit: mmol/L)
Description
The glucose of urine will be determined at Day 3, Day 7, Day 11 respectively,and it's one kind of laboratory test.
Time Frame
Day 3, Day 7, Day 11
Title
Urine protein (Unit: g/L)
Description
The protein of urine will be determined at Day 3, Day 7, Day 11 respectively,and it's one kind of laboratory test.
Time Frame
Day 3, Day 7, Day 11
Title
Number of subjects with adverse events
Description
It's the number of subjects with adverse events after administration.
Time Frame
Day 1 to Day 11
Title
AUC0-t of CN128
Description
Pharmacokinetics parameters
Time Frame
Day 1, Day 2, Day 3, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11
Title
AUC0-∞ of CN128
Description
Pharmacokinetics parameters
Time Frame
Day 1, Day 2, Day 3, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11
Title
Cmax of CN128
Description
Pharmacokinetics parameters
Time Frame
Day 1, Day 2, Day 3, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11
Title
Tmax of CN128
Description
Pharmacokinetics parameters
Time Frame
Day 1, Day 2, Day 3, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11
Title
t1/2 of CN128
Description
Pharmacokinetics parameters
Time Frame
Day 1, Day 2, Day 3, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11
Title
CL/F of CN128
Description
Pharmacokinetics parameters
Time Frame
Day 1, Day 2, Day 3, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11
Title
Vd/F of CN128
Description
Pharmacokinetics parameters
Time Frame
Day 1, Day 2, Day 3, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11
Title
MRT of CN128
Description
Pharmacokinetics parameters
Time Frame
Day 1, Day 2, Day 3, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11
Title
Css-av of CN128
Description
Pharmacokinetics parameters
Time Frame
Day 1, Day 2, Day 3, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11
Title
Css-min of CN128
Description
Pharmacokinetics parameters
Time Frame
Day 1, Day 2, Day 3, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11
Title
Css-max of CN128
Description
Pharmacokinetics parameters
Time Frame
Day 1, Day 2, Day 3, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11
Title
Accumulation rate of CN128
Description
Pharmacokinetics parameters
Time Frame
Day 1, Day 2, Day 3, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11
Title
Fluctuation index of CN128
Description
Pharmacokinetics parameters
Time Frame
Day 1, Day 2, Day 3, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11
Title
λz of CN128
Description
Pharmacokinetics parameters
Time Frame
Day 1, Day 2, Day 3, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Subject inclusion criteria: Thalassemia patients with serum ferritin ≥ 500 µg/L Patients aged 16 and above HB≥80 g/L before administration Voluntarily participate in the experiment, and the process of obtaining informed consent met the requirements of GCP. Subject exclusion criteria: Hepatitis B surface antigen positive, hepatitis B core antibody positive and HBV-DNA positive, hepatitis C anti-HCV positive, HIV positive, Treponema pallidum positive History of active digestive tract diseases (including gastric ulcer, duodenal ulcer, gastroesophageal varices, ulcerative colitis, Crohn's disease, digestive tract tumors, familial genetic polyps), history of digestive tract perforation, history of digestive tract surgery and influence on drug absorption, and other investigators believe that patients with potential intestinal complications Liver dysfunction (ALT or AST > 2.5×ULN); or renal dysfunction (serum creatinine > 1.5×ULN) Uncontrolled active infections Patients currently taking CYP3A strong inducer or inhibitor drugs or drugs that may prolong the QT interval without temporary suspension of use or temporary substitution of the said drugs Allergic constitution: allergic to or with contraindication of main ingredients or excipients of CN128 tablets (microcrystalline cellulose, cross-linked sodium carboxymethyl cellulose, silica, sodium stearate fumarate, Opadry) Patients who have abnormal ECG with clinical significance: congenital long QT syndrome or known family history of long QT syndrome; QTc > 450ms (male) or QTc > 470ms (female); patients who have ventricular or atrial tachyarrhythmia with clinical significance, etc Family planning participants (including male subjects) during or within three months after the trial Patients with a history of blood donation within 3 months before the trial Patients with a history of smoking (more than 5 cigarettes or products with equivalent nicotine per day), alcoholism (more than 14 units of alcohol per week: 1 alcohol unit equals 10 mL or 8 g pure alcohol; 25 mL 40% liquor, 330 mL 5% beer, 175 mL 12% red wine equals 1.0, 1.5, 2.0 alcohol units respectively), drug abuse and addiction history Patients who smoke, drink or eat any food containing alcohol, xanthine or grapefruit (including chocolate, tea, coffee or cola drinks) within 48 h before using of test drug The subjects should not join in other clinical drug or instrument study or some other clinical studies within 3 months before taking the study drug, except for non interventional studies; Patients with positive results of nicotine and urine drug screening Patients with difficulty in venous blood collection Patients with positive blood pregnancy test results Any patient with conditions which the investigators resume inappropriate to participate in this study, such as: poor health status, poor compliance, unwillingness or inability to comply with treatment regimens, including delayed visits
Facility Information:
Facility Name
The first affiliated hospital, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China

12. IPD Sharing Statement

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Short-term Clinical Study of CN128 in Thalassemia Patients

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