Anemia in chronic kidney disease

Primary Objectives: 1. To evaluate the safety and tolerability of a single escalating subcutaneous (SC) administration of UB-852 in healthy male adults by documenting the safety data, including adverse events (AEs), serious adverse events (SAEs), physical examinations, vital signs, electrocardiogram (ECG), clinical chemistry, complete blood count with differential count (CBC/DC), coagulation, iron and urinalysis test results. 2. To determine immunogenicity of UB-852 Secondary Objectives: 1. To assess the pharmacokinetic (PK) parameters of UB-852, including Cmax, Tmax, λZ, AUC0-t , AUC0-inf, t1/2, CL/F, Vz/F and the ratio of AUC0-t/AUC0-inf. The dose proportionality should be also assessed. 2. To evaluate pharmacodynamic (PD) of UB-852, including hematocrit (HCT), hemoglobin (HGB), red blood cell (RBC) and reticulocyte count, to characterize response to UB-852

UB-852

Injection

50, 150, 500

Primary Endpoints:
Safety
• Evaluation of treatment-related AEs and SAEs of UB-852
• Evaluation of treatment-related changes in physical examinations, vital signs, ECG, clinical chemistry, CBC/DC, coagulation, iron and urinalysis test results.

Immunogenicity
• To determine immunogenicity of UB-852

Secondary Endpoints:
Pharmacokinetics
• To assess the PK parameters of UB-852, including Cmax, Tmax, λZ, AUC0-t, AUC0-inf, t1/2, CL/F, Vz/F and the ratio of AUC0-t/AUC0-inf. The dose proportionality should be also assessed

Efficacy
• To evaluate PD of UB-852, including, HCT, HGB, RBC and reticulocyte count, to characterize response to UB-852

1. Male subjects aged between 20 (inclusive) to 60 years (inclusive) at the time of consent.
2. Subject’s body mass index is within the range of 18.5 (inclusive) to 27 (exclusive) kg/m2.
3. Subject’s iron test results are within the normal range (or considered clinically normal by the investigator).
4. Subject’s physical examination, vital signs and ECG results are with no particular clinical significance.
5. Subject’s general disease history (within 60 days prior to Screening) shows no particular clinical significance.
6. Subject’s chest X-ray result (within 180 days prior to Screening) shows no particular clinical significance.
7. Subject’s clinical chemistry test results are within the normal range (or considered clinically normal by the clinical investigator), including test items listed below
A. Albumin
B. Alkaline phosphatase (ALP)
C. ALT
D. Amylase
E. AST
F. BUN
G. Chloride
H. Creatinine
I. Gamma-glutamyl transpeptidase (γ-GT)
J. Globulin
K. Glucose
L. Potassium
M. Sodium
N. Total bilirubin
O. Total cholesterol
P. Total protein
Q. Triglyceride
R. Uric acid
8. Subject’s results from the CBC/DC, reticulocyte count and coagulation test are within the normal range (or considered clinically normal by the clinical investigator).
9. Subject’s urinalysis test results are within the normal range (or considered clinically normal by the clinical investigator).
10. Subject does not take any of the following medications within 30 days prior to dosing:
A. Any systemic medications as judged by the investigator
B. Any enzyme inducers or inhibitors
11. Subject must be using reliable contraception methods (e.g. spermicide in combination with condom) during the study and until 8 weeks after the dosing.
12. Subject is willing and able to participate in the study and comply with all study requirements.
13. Subject has signed the informed consent form.

1. Subject with any properly diagnosed disease within 60 days prior to Screening.
2. Subject has blood donation or blood loss > 250 mL within 90 days prior to dosing.
3. Subject has received an investigation product within 90 days prior to dosing.
4. Subject has used long-acting medications within 90 days prior to dosing.
5. Subject is with a history of drug or alcohol abuse.
6. Subject has smoked within 60 days prior to Screening.
7. Subject has taken prescription or over–the-counter medicine within 30 days prior to dosing.
8. Subject cannot stop consumption of alcohol, grapefruit and xanthine-containing products 48 hours prior to dosing and during the entire study.
9. Subject is hypersensitivity to epoetin or its excipients, known sensitivity to mammalian cell derived products, or with other contraindications for Erythropoiesis Stimulating Agent (ESA) therapy.
10. Subject has active infection with Hepatitis B virus or Hepatitis C virus, with positive result in HBsAg or HCV antibody test.
11. Subject who is positive in HIV test.
12. Subject has any evidence of serious active infections.
13. The clinical investigator considers that the subject is not in the condition to participate in this study.