A Phase II Randomised, Open-Label, Parallel Group Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Two Subcutaneous Dosing Regimens of ATL1103 in Adult Patients with Acromegaly.

Antisense Therapeutics Limited0 个研究点目标入组 24 人开始时间: 2012年9月13日最近更新: 2020年1月13日

适应症

试验速览

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•Provide written informed consent in accordance with local regulations.
•- Are 18 to 80 years of age inclusive.
•- Have acromegaly due to pituitary adenoma (micro or macro adenoma) identified by Magnetic Resonance Imaging (MRI).
•- Have serum IGF-I level at Screening >1.3 times the upper limit of normal (ULN).
•- Have nadir serum GH levels > 1ng/mL at all test time points within the 2 hours post oral glucose load for an oral glucose tolerance test (OGTT).
•- Are acromegaly treatment naive, or who have not taken other acromegaly medications for a period of 6 weeks to 4 months, depending on the medication.

•- Have acromegaly due to reasons other than pituitary adenoma.
•- Have participated in any clinical investigation with an investigational drug within 3 months (4 months if the drug is a new chemical entity) preceding the Baseline visit or during the washout period.
•- Have a history of clinically relevant gastrointestinal, hepatic, renal, endocrine (other than acromegaly), haematological, metabolic, neurologic or psychiatric disease that in the investigator’s opinion may compromise their safety or effect results from this study.
•- Have any other medical condition which, in the judgement of the Investigator, might interfere with the objectives of the study, or are otherwise unsuitable for participation.

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