A Randomised, Placebo Controlled, Double-Blind, Single Ascending Dose and Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Doses of ATL1103 in Healthy Adult Male Subjects

ATL1103 is being developed as a potential treatment for diseases of excessive growth hormone and insulin-like growth hormone (IGF-I) action. This is the first in man study for ATL1103, and is being conducted as a randomized, placebo-controlled, double-blind trial. Thirty six healthy male subjects will participate in the study. In stage A, subjects will receive one dose of either placebo or ATL1103 (at a dose of 25 mg, 75 mg, 250 mg or 400 mg). In stage B, subjects will receive 6 doses of placebo or ATL1103 (at a dose to be determined after review of the safety data from Stage A). All treatments will be administered by subcutaneous injection. The primary objectives of the study is to evaluate the safety and tolerability of single or multiple injections of ATL1103, and to investigate the pharmacokinetic profiles of ATL1103 after subcutaneous administration. The effect of ATL1103 on serum IGF-I levels will also be monitored.