Study to Evaluate and Compare the PK Profiles of Abaloparatide-SC and Abaloparatide-sMTS in a Cohort of Healthy Men and Healthy Women.

Radius Health

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Combination Product: abaloparatide-sMTS; Combination Product: abaloparatide-SC

Study type: Interventional

Funder types: Industry

Identifiers

NCT04663464

BA058-05-024

Details and patient eligibility

About

A study to evaluate and compare the PK profiles of abaloparatide-SC 80 μg and abaloparatide-sMTS 300 μg in a cohort of healthy men and to make a similar evaluation in a cohort of healthy women

Full description

This study aims to evaluate and compare the pharmacokinetic (PK) profiles of abaloparatide-SC 80 μg injected subcutaneously into the periumbilical region of the abdomen, and abaloparatide-sMTS 300 μg applied to the thigh for 5 minutes in a cohort of healthy men and to make a similar evaluation in a cohort of healthy women.

Enrollment: 52 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Male and female subjects aged 40 to 65 years old, inclusive, at Screening;
• Good general health as determined by medical history and physical exam (including vital signs, and has a body mass index between 18 and 32 kg/m^2;
• Laboratory test results within the normal range
• Serum 25-hydroxyvitamin D values must be > 20 ng/mL.

Exclusion Criteria:

• Presence or history of any disorder that may prevent the successful completion of the study;
• Diagnosed with osteoporosis, Paget's disease, or other metabolic bone diseases (eg, vitamin D deficiency or osteomalacia), or had a non-traumatic fracture within 1 year prior to the initial screening;
• History of any cancer within the past 5 years other than squamous or basal cell carcinoma;
• History of allergy to abaloparatide or drugs in a similar pharmacological class;.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

abaloparatide-SC (Period 1) followed by abaloparatide-sMTS (Period 2)

Experimental group

Description:

Abaloparatide-SC injection (Period 1) followed by abaloparatide-sMTS application (Period 2). Abaloparatide-SC is a drug-device combination product consisting of abaloparatide, an active synthetic peptide analog of parathyroid hormone related peptide (PTHrP), administered to the periumbilical region via an injection pen. Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide.

Treatment:

Combination Product: abaloparatide-SC

Combination Product: abaloparatide-sMTS

Abaloparatide-sMTS (Period 1) followed by abaloparatide-SC (Period 2)

Experimental group

Description:

Abaloparatide-sMTS (Period 1) application followed by Abaloparatide-SC injection (Period 2).

Treatment:

Combination Product: abaloparatide-SC

Combination Product: abaloparatide-sMTS