Safety, Tolerability, PK and PD of SAD or MAD of APX-115 in Healthy Male Volunteers
Double Blind, Randomized Study Assessing the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses or Multiple Ascending Doses of APX-115 in Healthy Male Volunteers.
Lead SponsorAptabio Therapeutics, Inc.
StatusCompleted No Results Posted
Intervention/TreatmentSAD: APX-115 MAD: APX-115 Metabolic probe with or without APX-115 ...
This study aims to evaluate the safety, tolerabilty, pharmacokinetics and pharmacodynamics of single ascending doses and multiple ascending doses of APX-115 in healthy males. This study also aims to evaluate the effect of food consumption on the pharmacokinetics of APX-115 and potential interaction between caffeine and APX-115 in healthy males.
Drug: APX-115 SAD APX-115 SAD for 1day
Drug: Placebo Placebo for 1day
Drug: APX-115 MAD APX-115 MAD repeatedly administered.
Matching study drug will be repeatedly administered.
A single dose of APX-115, selected from the SAD study, will be administered under fasted and fed condition.
A metabolic probe will be administered with and without APX-115.
Experimental: APX-115 SAD group
Experimental: Placebo group
Experimental: APX-115 MAD group
Experimental: Placebo group
Experimental: APX-115 under fasting condition
Experimental: APX-115 under fed condition
Experimental: metabolic probe
Inclusion: Healthy male subject, aged between 18 and 45 years inclusive Certified as healthy by a comprehensive clinical assessment Normal dietary habits Normal ECG recording on a 12-lead ECG Signing a written informed consent prior to selection Exclusion: Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic, infectious or ocular disease Frequent headaches and / or migraine, recurrent nausea and / or vomiting Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in SBP or DBP equal to or greater than 20 mmHg within two minutes when changing from the supine to the standing position Blood donation (including in the frame of a clinical trial) within 2 months before administration General anaesthesia within 3 months before administration Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician Inability to abstain from intensive muscular effort No possibility of contact in case of emergency Any drug intake (except paracetamol or contraception) during the last month prior to the first administration History or presence of drug or alcohol abuse (alcohol consumption > 30 grams / day) Excessive consumption of beverages with xanthine bases (> 4 cups or glasses / day) Positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests Positive results of screening for drugs of abuse Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development Administrative or legal supervision