Phase I, open-label, sequential-group, three-cohort study to evaluate the pharmacokinetic profile, the safety and the tolerability of a single injection of lanreotide Extended-Release Formulation (ERF) at doses of 120 mg and 240 mg in healthy volunteers

Exclusion Criteria30

• A subject will not be eligible for inclusion if any of the following criteria applies during screening or prior to enrolment:
• Inability or unwillingness to comply with study requirements.
• Known thyroid disease, even if effectively euthyroid because of treatment.
• Known hypersensitivity to any component of the study drug.
• Planning for male subjects to donate sperm for at least 90 days after dosing with the study drug.
• Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator’s opinion, could adversely affect the safety of the subject.
• Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the subject will comply with the protocol or complete the study per protocol.
• Any surgical or medical condition that could interfere with the absorption, distribution, metabolism or excretion of the study drug, including impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhoea.
• Having undergone any major surgery during the 3 months prior to study drug administration.
• Blood donation or significant blood loss (greater than or equal to 500mL) within 30 days prior to study drug administration.
• Fever (body temperature greater than 38°C) or symptomatic viral or bacterial infection within 2 weeks prior to study drug administration.
• Any acute illness within 30 days prior to study drug administration.
• History of severe allergic or anaphylactic reactions.
• Presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis).
• History of malignancy except for non-melanoma skin cancer excised more than 1 years prior to study drug administration.
• Abnormal electrocardiogram (ECG) findings at Screening including PR greater than 220 msec, QRS greater than or equal to 120 msec, and QT interval corrected using Fridericia's correction (QTcF) greater than 450 msec, ST wave changes or any other abnormal findings that are considered by the Investigator to be clinically significant.
• History or presence of a condition associated with significant immunosuppression.
• Exposure to any significantly immune suppressing drug (including experimental therapies as part of a clinical trial) within the 4 months prior to dosing or 5-half-lives, whichever is longer.
• Positive test for hepatitis C (HCV) virus antibody, hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening.
• Subjects with a positive urine drug screen test (including , amphetamines, methamphetamines, phencyclidine, barbiturate, methadone, tricyclic antidepressant, cocaine, opiates, cannabinoids and benzodiazepines) at Screening or Day -1.
• Subjects with a history of substance abuse or dependency or history of recreational intravenous (IV) drug use over the last 2 years (by self-declaration).
• Regular alcohol consumption defined as greater than 21 alcohol units per week for males, or greater than 14 units per week for females (where 1 unit equals 284 mL of beer, 25 mL of 40% spirit, or a 125 mL glass of wine).
• Subjects unwilling to abstain from alcohol beginning 48 hours prior to admission to the Clinical Research Unit (CRU) and during the confinement period.
• Regular consumption of stimulating beverages, defined as greater than5 coffees, teas, or coca cola drinks/ day or greater than 3 energy drinks/week.
• Subjects unwilling to abstain from stimulating beverages consumption beginning 48 hours prior to admission to the CRU and during the confinement period.
• Subjects who smoke greater than 10 cigarettes per week or equivalent use of nicotine-based products (including smoking tobacco, smokeless tobacco and nicotine patches) within 30 days prior to Screening.
• Use of any IP or investigational medical device within 30 days prior to dosing or 5 half-lives of the product (whichever is the longest) or participation in more than 4 investigational drug studies within 1 year prior to Screening.
• Use of any prescription drugs, over the counter (OTC) medication, herbal remedies, supplements or vitamins within 7 days prior to dosing and during course of study without prior approval of the Investigator and Medical Monitor. Simple analgesia (paracetamol) may be permitted at the discretion of the Investigator. Oral contraceptives are permitted.
• Subjects unwilling to refrain from strenuous exercise (including weightlifting) from the dosing day (Day 1) until completion of Day 7 visit.
• Have received or plan to receive any vaccine within 7 days prior to dosing through to 7 days after dosing.