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Short-term Clinical Study of CN128 in Thalassemia Patients

NCT03935633 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-06-09

No results posted yet for this study

Summary

1. 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
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. Statistics

Conditions

Interventions

DRUG

CN128 Tablets

Iron chelator， oral tablets

Sponsors & Collaborators

  • Hangzhou Zede Pharma-Tech Co., Ltd.

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
16 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-03
Primary Completion
2019-05-06
Completion
2019-12-17

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03935633 on ClinicalTrials.gov