Osteoporosis Clinical Trial
The objective of this study is to investigate the pharmacokinetics, safety, and tolerability of AK159 administered to healthy postmenopausal women.
This study consists of Part 1 and Part 2. <Part 1> Part 1 will be conducted according to a
single-centre, randomized, single-dose, 3-period, 5-treatment alternating crossover design
in two groups of healthy post-menopausal women The pharmacokinetics, safety, and
tolerability of a single dose of AK159 (4 levels) will be investigated versus teriparatide
acetate for injection as a control.
<Part 2> Part 2 will be conducted according to a multiple-centre, randomized, double-blind,
placebo-controlled, repeated dose parallel design of healthy post-menopausal women The
pharmacokinetics, safety, and tolerability of AK159 (4 levels) for 8 weeks will be
investigated versus teriparatide acetate for injection and placebo as controls.
Pharmacokinetics, safety, and tolerability following long-term application will also be
investigated.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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