Iron Overload Iron Overload Iron Chelating Agents
Conditions
Interventions
The trial will start with the lowest dose of CN128 given to 4 subjects (1 mg/kg body weight [bw],
single dose).
A second group of 4 subjects will receive the next higher dose (5 mg/kg bw,
single dose).
A third group of 8 subjects will receive the following higher dose of CN128 of 10 mg/kg bw,
single dose.
A fourth group of 8 subjects will receive the following higher dose of CN128 of 20 mg/kg bw,
single dose.
A fifth group of 8 subjects will receive the following higher dose of CN128 of 30 mg/kg bw,
single dose.
A sixth group of 8 subjects will receive the following higher dose of CN128 of 45 mg/kg bw,
single dose.
A final group of 4 subjects will receive the following higher dose of CN128 of 60 mg/kg bw,
single dose.
Each dose group will consist of 50% male and 50% female subjects and in each dose group the study drug administration will be performed in the male subjects first.
Experimental Drug
Sponsors
Professor Yongping Yu
Professor Robert C Hider
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Male or female 2.Age between 18 and 65 years (inclusive) 3.Women of childbearing potential must have a negative pregnancy test (ß-HCG test) and be willing to use an effective method of birth control (contraceptive pill and condom for the male partner) from screening to one month after administration of CN128 4.No known significant illness, i.e. diseases whose physical and social symptoms can have an impact on sufferers’ abilities to lead normal everyday lives 5.Organ functions, such as heart, liver and kidney, in the normal range 6.Body mass index (BMI) between 18.5 and 30 (normal to overweight) 7.Informed consent (see section 10.5) to trial participation in writing encompassing consent to data recording and verification procedures, to be given before the first administration of trial medication.
Exclusion criteria
Exclusion criteria: 1.Signs and symptoms of any acute or chronic illness preventing the subject’s ability to lead normal everyday live 2.Any evidence/suspicion of cancer of any type 3.Systemic disease infectious or other 4.History of cardiac disease defined as myocardial infarction, congestive heart failure, angina, electrocardiographic evidence of acute ischemia, or clinically significant cardiac arrhythmias (i.e. the subject should have no symptoms and need no specific treatment) 5.History of stroke 6.ALT or AST values exceeding 3x upper limit normal (ULN) 7.ALP, PT (or its international normalized ratio [INR]) or bilirubin out of normal range values 8.eGFR equal or below 60 ml/min (CKD-Epi-formula) 9.Fasting glucose value > 100 mg/dL 10.Any bleeding disorder or acute blood coagulation defect 11.Any kind of surgery in the last 2 weeks before inclusion 12.Hypertension defined as repeated measurements of blood pressure more than 140 mmHg systolic and more than 90 mmHg diastolic 13.Pregnancy or lactation period 14.Undiagnosed vaginal bleeding 15Use of other investigational drugs/treatments in the 6 months previous to enrolment 16.History of or current alcohol or drug abuse which, in opinion of the investigator, makes the subject unfit for participation in the study 17.Any other condition that, in the opinion of the investigator, may jeopardize the study conduct according to the protocol (condition should be described by the investigator). Ethical/Other: 18.Subjects committed to an institution by virtue of an order issued either by the judicial or the administrative authorities 19.Subjects dependent on the sponsor, investigators, personnel of the trial site or any other individual whose willingness to volunteer may be unduly influenced by the expectation, whether justified or not, of benefits associated with study participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics after one single dose administration Pharmacokinetics,Safety and tolerability after one single dose administration assessing the observed adverse reactions | — |
Secondary
| Measure | Time frame |
|---|---|
| Pediatric balance scale 0,2,4,8week Physical examination | — |
Countries
Thailand
Contacts
Public ContactRobert Hider
King's College London
Outcome results
None listed