Assessing the Safety and Ability of SG1002 to Overcome Deficits in Hydrogen Sulfide in Heart Failure Patients

Inclusion Criteria (healthy volunteers):

• Healthy male volunteers aged between 18 and 45 years (inclusive);
• Body mass index between 19 and 30 kg/m^2 (inclusive);
• No clinically significant findings in the medical history and physical examination;
• No clinically significant laboratory values and urinalysis, unless the investigator considers any abnormality to be clinically irrelevant;
• Normal ECG, blood pressure and heart rate, unless the Investigator considers any abnormality to be not clinically significant (NCS);
• Willing to use contraception (single barrier methods); and
• Willing and able to provide written informed consent.

Exclusion Criteria (healthy volunteers):

• Have received blood products within 1 month prior to Screening;
• Have received any investigational research agent within 30 days or 5 half-lives (whichever is longer) prior to the first dose of trial medical food;
• Have received an investigational vaccine within 6 months, a live attenuated vaccine within 60 days or a registered vaccine within 30 days prior to the first dose of the trial medical food;
• Have a history of thyroidectomy or thyroid disease that required medication within the past 12 months;
• Have had serious angioedema episodes within the previous 3 years or requiring medication in the previous two years;
• Have a bleeding disorder diagnosed by a doctor (for example factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties during blood draws;
• Have a psychiatric condition that precludes compliance with the protocol, past or present psychoses, past or present bipolar disorder, or a disorder requiring lithium, within five years prior to enrolment;
• Has a history of suicide plan;
• Any clinically significant abnormality at Screening determined by medical history, physical examination, blood chemistry, haematology, urinalysis and a 12-lead ECG, or positive urine screen for drugs of abuse;
• Any other condition which in the view of the Investigator is likely to interfere with the study or put the subject at risk;
• HIV, or hepatitis B or C positive;
• Have a history of or current clinically significant gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, oncological, immunodeficiency, neurological, metabolic, haematological or autoimmune disorder;
• Have a history of or current tuberculosis, epilepsy, diabetes or glaucoma;
• Have clinical signs of active infection or a temperature more than 38.0°C at the time of screening. Study entry may be deferred at the discretion of the Principal Investigator;
• Have evidence of drug or alcohol abuse;
• Be unable to provide repeated blood samples without undue trauma or distress;
• Anticipate surgery within the trial period; or
• Inability to speak English (due to need to administer standardized English-language questionnaire).

Inclusion Criteria (heart failure subjects):

• Aged between 35 and 85 years (inclusive);
• Has symptomatic heart failure, with New York Heart Association (NYHA)classification of II or III;
• Ambulatory;
• Left ventricular ejection fraction less than 40%;
• Congestive heart failure has been stable for the previous 3 months (defined by no change in baseline therapy or symptoms of heart failure for the previous 3 months); and
• Willing and able to provide written informed consent.

Exclusion Criteria (heart failure subjects):

• Subject is pregnant or breastfeeding;
• If female, the subject is either post-menopausal or surgically sterilised or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) from signing of the informed consent form though to the Final Visit/Early Termination Visit;
• Myocardial infarction, unstable angina, stroke, cerebrovascular accident, percutaneous coronary intervention, open heart surgery or transient ischemic attack (TIA) within 3 month