An Exploratory Phase IIa Study to Investigate the Biological Activity of Oral FX125L in Adult Patients with Chronic Inflammatory Disease

Funxional Therapeutics Ltd0 sitesOctober 31, 2011

Overview

No summary available.

Registry

who.int

Start Date

October 31, 2011

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Funxional Therapeutics Ltd

•1\.Willing and able to give written informed consent and to comply with the requirements of the study.
•2\.Male or female aged 18–77 years, inclusive.
•3\.Body mass index 18–35 kg/m2, inclusive.
•4\.Females of child\-bearing potential must be using an adequate and medically acceptable contraception method.
•5\.Females of child\-bearing potential must not be lactating or pregnant (negative serum beta\-human chorionic gonadotropin on Screening or urine pregnancy test at Day \-1 visit).
•6\.Male patients must agree not to donate sperm, and to take appropriate precautions to avoid fathering a child, throughout the study and until 90 days after the end of treatment.
•7\.Ability to produce an analysable sample of sputum at Screening. This is defined as a) a sputum plug with a weight exceeding 500 mg and b) more than 300 intact leukocytes on a cytospin slide.
•In addition, patients must meet the inclusion criteria for a chronic inflammatory disease as follows:
•1\.Documented diagnosis of asthma at least 6 months prior to Screening or equivalent that confirms the diagnosis meets this criteria
•2\.Forced expiratory volume in 1 second \=60% and \=90% of predicted at Screening and Randomisation (Day \-1\).

•1\.Any condition, including findings in the medical history or in the pre\-study assessments, which, in the opinion of the Investigator, constitute a risk or contraindication for the participation of the subject in the study, or that could interfere with the study objectives, conduct, or evaluation including, but not limited to:
•\-Any clinically significant abnormality in the results of screening safety laboratory tests.
•\-Positive test for drugs of abuse.
•\-Positive alcohol breath test.
•\-Positive results from serum tests for hepatitis B surface antigen (except if due to vaccination), hepatitis C, or HIV.
•\-History or presence of liver disease.
•\-History or presence of endocrine disorders or diseases affecting the hypothalamic\-pituitary\-adrenal axis, including acromegaly, growth hormone deficiency, adrenal insufficiency, Cushing’s syndrome, Grave’s Disease, Hashimoto’s Disease, uncontrolled diabetes mellitus, with the exception of idiopathic hypothyroidism in patients \> 60 years.
•\-History of hypofertility.
•\-History of cancer in the preceding 5 years (except adequately treated basal cell carcinoma of the skin and squamous cell carcinoma in situ of the skin)
•2\.History or presence of drug or alcohol abuse.