Clinical Study of AK159 in Healthy Postmenopausal Women

Asahi Kasei Medical

Status and phase: Completed; Phase 1

Conditions: Osteoporosis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01551602

AK159 I-1

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 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.

Enrollment: 132 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; and 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
• Systolic blood pressure < 90 mmHg
• QTc exceeds 470 msec in a 12-lead electrocardiography
• 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: Quadruple Blind

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132 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 MN-10-T

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