A Phase I Study of AK159 in Healthy Postmenopausal Women

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

The objective of this study is to investigate the pharmacokinetics, safety, and tolerability of AK159 administered to healthy postmenopausal women.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Asahi Kasei Pharma Corporation
• Treatments: Teriparatide

Criteria

Inclusion Criteria:

• Healthy postmenopausal ethnic Japanese women

• At least 45 years of age at the time consent is obtained

• Give voluntary consent in writing with a sufficient understanding of the study.

Exclusion Criteria:

• Clinical abnormality identified in the laboratory tests

• Weight < 40.0 kg

• Body mass index < 17.5 or >=30.5

• History of disease of the kidneys, liver, heart, brain, or other organ that makes them ineligible as subjects

• Previously received radiation treatment potentially affecting bone

• Clinical abnormality identified in the 12-lead ECGs performed at the study center during the screening period

• Systolic blood pressure < 90 mmHg

• Serum calcium level exceeding 10.4 mg/dL

• History of contact dermatitis or skin disease potentially compromising study evaluation

• Used drugs which impact bone metabolism in the 8-week period preceding investigational product administration

• Used a bisphosphonate

• Used a teriparatide product