OAP-189

Physical examination included examination of skin, head, eyes, ears, nose, throat (HEENT), heart, lungs, abdomen, extremities, neurological function, back and lymph nodes. Clinically significant physical examination abnormalities were considered as adverse events based on investigator's discretion.

Criteria for clinically significant vital sign abnormalities: sitting systolic blood pressure (SBP) of (greater than equal to) \>=160 millimeter of mercury (mmHg), (less than equal to) \<=90 mmHg, \>=20 mmHg increase and decrease from baseline; sitting diastolic blood pressure (DBP) of \>=100 mmHg, \<=50 mmHg, \>=15 mmHg increase and decrease from baseline; heart rate of \>=120 beats per minute (bpm), \<=45 bpm, (greater than) \>15 bpm increase and decrease from baseline, orthostatic SBP: decrease of \>=20 mm Hg from sitting value, orthostatic DBP: decrease of \>=20 mm Hg from sitting value, orthostatic heart rate: increase of \>=30 bpm from sitting value, oral temperature of (less than) \<35 or \>38.3 degree celsius, respiratory rate of \<10 or \>25 breaths per minute, weight: maximum increase or decrease of \>=7 percent (%) from baseline.

Criteria for clinically significant ECG abnormalities: PR interval \>=220 millisecond (msec) or a change of \>=20 msec from baseline values, QRS interval \>=120 msec, QTc interval \>450 msec (in males) and \>470 msec (in females).

Hematocrit, haemoglobin: decrease of \>=0.05 L/L and \>=20 g/L from baseline respectively, WBC count:\<3\*10\^9 /L, neutrophils: \<1.5\*10\^9 /L, platelet count: \<100\*10\^9 /L, eosinophil: \<0.5\*10\^9 /L; prothrombin time, partial thromboplastin time \>1.5\*upper limit of normal (ULN); sodium:\>5 mmol/L above ULN or below lower limit of normal(LLN), potassium \>0.5 mmol/L above ULN or below LLN, creatinine \>1.36\*ULN, blood urea nitrogen \>1.5\*ULN, glucose (fasting) \>0.83 mmol/L above ULN or below LLN, glucose (non-fasting) \>5 mmol/L above ULN or \>0.56 below LLN, calcium, magnesium: Change of \>=0.25 and \>=0.21 mmol/L from baseline respectively, phosphorus \>0.162 mmol/L above ULN or below LLN, total protein, albumin, uric acid: change of \>=20g/L, \>=10 g/L, \>0.119 mmol/L from baseline respectively, creatinine kinase \>3\*ULN, total cholesterol \>7.77 mmol/L, triglycerides \>3.39 mmol/L: AST, ALT, total bilirubin \>2\*ULN, alkaline phosphatase \>1.5\*ULN, alpha-glumatyl transferase, lactate dehydrogenase \>3\*ULN.

Injection site reactions included irritation, erythema, pain, hematoma, inflammation.

Criteria: Blood glucose levels \>15 milligram per deciliter (mg/dL) above ULN or \>15 mg/dL below LLN.

Hypoglycaemia is a condition characterized by abnormally low blood glucose (blood sugar) levels, usually \<=50 mg/dL.

Criteria for drug induced liver injury: Levels of aspartate transaminase (AST) or alanine transaminase (ALT) should be \>= 3 times ULN concurrent with a total bilirubin of \>=2 times ULN with no evidence of hemolysis and an alkaline phosphatase should be \<=2 times ULN.

Fasting glucose levels were determined before administration of OAP-189 using a glucometer.

Fasting glucose levels were determined before administration of OAP-189 using a glucometer.