A Phase I Study of AK159 in Healthy Postmenopausal Women

Asahi Kasei Medical

Status and phase: Completed; Phase 1

Conditions: Osteoporosis

Treatments: Drug: MN-10-T; Drug: Placebo; Drug: AK159

Study type: Interventional

Funder types: Industry

Identifiers

NCT01935479

AK159 I-4

Details and patient eligibility

About

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

Full description

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.

Enrollment: 170 estimated patients

Sex: Female

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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170 participants in 11 patient groups, including a placebo group

AK159 SD 1

Experimental group

Description:

Single administration of AK159 dose level 1

Treatment:

Drug: AK159

AK159 SD 2

Experimental group

Description:

Single administration of AK159 dose level 2

Treatment:

Drug: AK159

AK159 SD 3

Experimental group

Description:

Single administration of AK159 dose level 3

Treatment:

Drug: AK159

AK159 SD 4

Experimental group

Description:

Single administration of AK159 dose level 4

Treatment:

Drug: AK159

MN-10-T SD

Active Comparator group

Description:

Single administration of teriparatide acetate

Treatment:

Drug: MN-10-T

AK159 MD 1

Experimental group

Description:

Multiple administration of AK159 dose level 1

Treatment:

Drug: AK159

AK159 MD 2

Experimental group

Description:

Multiple administration of AK159 dose level 2

Treatment:

Drug: AK159

AK159 MD 3

Experimental group

Description:

Multiple administration of AK159 dose level 3

Treatment:

Drug: AK159

AK159 MD 4

Experimental group

Description:

Multiple administration of AK159 dose level 4

Treatment:

Drug: AK159

MN-10-T MD

Active Comparator group

Description:

Multiple administration of MN-10-T

Treatment:

Drug: MN-10-T

Placebo MD

Placebo Comparator group

Description:

Multiple administration of placebo AK159

Treatment:

Drug: Placebo