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Clinical Study of CN128 in Thalassemia Patients

NCT03673085 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-12-19

No results posted yet for this study

Summary

1. Primary objectives:

* To determine the maximum tolerated dose (MTD) of CN128 for single oral administration in thalassemia patients aged 16 and above
* To study the pharmacokinetics of CN128 in thalassemia patients aged 16 and above
2. Design:

The study is designed as a randomized, double-blind, single ascending dose, phase Ia (first in human) trial.

The study is consisted of: single dose ascending; dose escalation pharmacokinetics; metabolite structure identification in plasma, urine and feces.
3. Subject inclusion criteria:

* Thalassemia patients with serum ferritin ≥500 μg/L
* Patients aged 16 and above
* Without blood transfusion within 1 week before admission, with hemoglobin ≥ 80 g/L
* Voluntarily participate in the experiment, and the process of obtaining informed consent form meeting 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
* Patients with history of active digestive tract diseases (including gastric ulcer, duodenal ulcer, gastroesophageal varices, ulcerative colitis, Crohn's disease, digestive tract tumors, familial genetic multiple intestinal polyps), history of digestive tract perforation, history of digestive tract surgery and influence on drug absorption, and other patients whom investigators believe to have 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:

After fasting for at least 10 hours, the whole tablet was swallowed with 240 mL warm water on an empty stomach. Water was forbidden within 1 hour before and after the administration. Water was allowed 1 hour after 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 etc.
7. Safety and tolerability assessments:

Evaluation was based on the incidence of adverse events (AE) after administration, termination information, laboratory test results, 12-lead electrocardiogram and vital signs.
8. Statistics

Conditions

Interventions

DRUG

CN128

CN128

OTHER

placebo

The tablets without CN128

Sponsors & Collaborators

  • Hangzhou Zede Pharma-Tech Co., Ltd.

    lead OTHER

Principal Investigators

  • Jianzhong Shentu · Single center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-05
Primary Completion
2018-10-16
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 NCT03673085 on ClinicalTrials.gov