Single ascending dose

The Phase I study was designed as a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the pharmacokinetics and pharmacodynamics of the new ERA. Cohorts of nine subjects with baseline hemoglobin levels less than 14.5 g/dl were randomized to receive ERA treatment (N= 6) or matched placebo (N= 3) at each dose level. The various dose levels considered in this study were lx, 3x, lOx, 30x, lOOx, and 300x. The objective of the study was to identify the pharmacological effective dose (PED), defined as the dose level where four or more treated subjects achieved more than 1 g/dl increase from baseline in hemoglobin within 28 days. 

Note-. DBP = double-barrier protection, MAD = multiple (repeated) ascending dose, WCBP = women of child-bearing potential, MD = multiple (repeated) dose, NHV = normal human volunteers, SAD = single ascending dose. 

I Clinical pharmacology studies Single-ascending-dose safety, PK, and PD Multiple-ascending-dose safety, PK, and PD Proof of mechanism study... 

FIH studies are typically conducted in healthy subjects beginning with a single ascending dose study with the primary objective being safety assessment. Secondary objectives include PK and PD assessments if possible. Statistical analyses are typically descriptive. Dose escalation continues until potential... 

Single ascending-dose TK in rat, dog, or monkey Finding NOAEL AUC, C ,ax, exposure multiples... 

The randomized, double-blind, placebo-controlled, single-ascending-dose trial will evaluate PGllO in patients with pain from osteoarthritis of the knee. 

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