The objective of this study is to investigate the pharmacokinetics, safety, and tolerability of AK159 administered to healthy postmenopausal women.
This study consists of two parts: Part 1 and Part 2. The Part 1 is a single-center, randomized, 2-way crossover study that investigates the pharmacokinetics, safety, and tolerability of teriparatide after a single dose of AK159 (5 levels) and estimates the relative bioavailability of AK159 with subcutaneous teriparatide acetate in healthy post-menopausal women. The Part 2 is a multiple-center, randomized, double-blind, positive- and placebo-controlled, parallel study that compares the pharmacokinetics, bone makers, safety, and tolerability of teriparatide after a weekly doses of AK159 (4 levels) for 6 weeks with placebo and a weekly doses of subcutaneous teriparatide acetate in healthy post-menopausal women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
170
Unnamed facility
Fukuoka, Japan
Unnamed facility
Kumamoto, Japan
Unnamed facility
Sumida City, Japan
Area under the plasma concentration versus time curve (AUC) of teriparatide
Time frame: up to 6 hours after single and repeated administration
Peak Plasma Concentration (Cmax) of teriparatide
Time frame: up to 6 hours after single and repeated administration
Number of subjects with adverse events and Incidence of adverse events
Time frame: up to 7 weeks after the initial administration
Change in bone turnover markers from baseline
Time frame: up to 7 weeks after the initial administration
Visual assessment of the application site
Time frame: up to 7 weeks after the initial administration
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