Thalassemia

CN128 Tablets

The first affiliated hospital, Zhejiang University

Short-term Clinical Study of CN128 in Thalassemia Patients

Phase Ib Clinical Study to Assess the Safety, Tolerability and Pharmacokinetic Parameters of CN128 Tablets to Administration in Thalassemia Patients Aged 16 and Above

The patient's height will be determined, and it's one kind of Physical examination.

The patient's weight will be determined, and it's one kind of Physical 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.

The patient's pulse will be determined, and it's one kind of vital signs checks.

The patient's respiration will be determined, and it's one kind of vital signs checks.

Both patient's systolic and diastolic blood pressure will be measured, and it's one kind of vital signs checks.

The patient's temperature will be determined, and it's one kind of vital signs checks.

The patient's electrocardiogram will be measured, and it's one kind of laboratory test.

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.

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.

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.

The patient's serum iron will be determined at Day 11, and it's one kind of laboratory test.

The colour of urine will be observed at Day 3, Day 7, Day 11 respectively，and it's one kind of laboratory test.

The appearance of urine will be observed at Day 3, Day 7, Day 11 respectively，and it's one kind of laboratory test.

The glucose of urine will be determined at Day 3, Day 7, Day 11 respectively，and it's one kind of laboratory test.

The protein of urine will be determined at Day 3, Day 7, Day 11 respectively，and it's one kind of laboratory test.

It's the number of subjects with adverse events after administration.

Hangzhou Zede Pharma-Tech Co., Ltd.

CN128

placebo

Clinical Study of CN128 in Thalassemia Patients

A First in Human, Randomized, Double-blind, Single Ascending Dose, Phase Ia Clinical Study to Assess the Safety, Tolerability and Pharmacokinetic Parameters of CN128 Tablets in Thalassemia Patients Aged 16 and Above

Vital signs checks; determine the patient's pulse which is one kind of physiological parameter

Vital signs checks; determine the patient's respiration which is one kind of physiological parameter

Vital signs checks; both systolic and diastolic will be measured

Laboratory test: WBC, RBC, NEUT, BASO, etc.

Laboratory test: colour, appearance, glucose, protein, ketone, bilirubin, leukocyte, blood, and microscopic

Laboratory test: ALT, AST, ALP, LDH, AMS, BUN, ALB, etc.

Laboratory test: fibrinogen, prothrombin time and corresponding INR, APTT

Pharmacokinetics parameters: mean residence time

Attention Deficit Hyperactivity Disorder (ADHD)

Binge-Eating Disorder Disorder

dasotraline

Clinical Pharmacology of Miami, Inc.

Orlando Clinical Research Center

Atlanta Center for Medical Research

DaVita Clinical Research

American Research Cororation (ARC), Texas Liver Instituete (TLI)

Study of the What the Body Does to the Drug in Subjects With Mild, Moderate, and Severe Liver Dysfunction

Pharmacokinetics of Orally Administered Dasotraline in Subjects With Mild, Moderate, and Severe Hepatic Dysfunction

Plasma PK parameters: Area under the plasma/serum concentration-time curve from time zero to infinity (AUC0 inf)

Plasma PK parameters: time of occurrence of Cmax

Urine PK parameters: amount excreted in urine from time zero to time t (AEx0 t)

Urine PK parameters: renal clearance (CLR)

Urine PK parameters: percent of dose excreted in urine (%fe)

Unbound fraction of dasotraline in plasma at 10, 12, and 24 hours postdose .

Incidence of adverse events (AEs), SAEs, and AEs resulting in study discontinuation.

Absolute values and changes from baseline in clinical laboratory tests (hematology, serum chemistry, urinalysis, prothrombin time), vital signs (respiratory rate, body temperature, supine blood pressure, and supine pulse rate), and 12 lead ECGs.

Frequency of subjects with suicidal ideation or suicidal behavior using the Columbia Suicide Severity Rating Scale (C SSRS).

Plasma PK parameters: AUC0-last, area under the blood concentration time curve from time zero to 24 hours postdose (AUC0-24)

Plasma PK parameters: time of occurrence of Cmax (tmax)

Plasma PK parameters: apparent clearance (CL/F)

Plasma PK parameters: apparent volume of distribution (Vz/F)

varicose veins/nikotin

Short-term Clinical Study of CN128 in Thalassemia Patients

Clinical Study of CN128 in Thalassemia Patients

Study of the What the Body Does to the Drug in Subjects With Mild, Moderate, and Severe Liver Dysfunction

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