Study to Evaluate and Compare the Bioequivalence of Two Abaloparatide-sMTS Treatments in Healthy Women.

Radius Health

Status and phase: Completed; Phase 1

Conditions: Osteoporosis

Treatments: Combination Product: abaloparatide-sMTS (Kindeva); Combination Product: abaloparatide-sMTS (Patheon)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04936984

BA058-05-023

Details and patient eligibility

About

A study to evaluate the bioequivalence of abaloparatide between 2 abaloparatide-sMTS treatments 300 μg treatments applied to the thigh for 5 minutes.

Full description

This is a single site, open-label, randomized, 4-period crossover study to evaluate the bioequivalence of 2 abaloparatide-sMTS 300 μg treatments (Patheon sterile abaloparatide-sMTS and Kindeva ultra-low bioburden abaloparatide-sMTS) applied to the thigh for 5 minutes. The study will also evaluate the effect of small deviations in the wear-time of the Patheon abaloparatide-sMTS worn for 4 minutes or 7 minutes compared to the Patheon abaloparatide-sMTS worn for the prescribed 5 minutes.

Enrollment: 36 patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 34 kg/m^2 inclusive)
• Laboratory tests 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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36 participants in 4 patient groups

Patheon sMTS 5 min, then by Kindeva sMTS 5 min, then Patheon sMTS 4 min, then Patheon sMTS 7 min

Experimental group

Description:

Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. The abaloparatide-sMTS is manufactured at Patheon (sterile environment) or Kindeva (low bioburden environment).

Treatment:

Combination Product: abaloparatide-sMTS (Patheon)

Combination Product: abaloparatide-sMTS (Patheon)

Combination Product: abaloparatide-sMTS (Kindeva)

Combination Product: abaloparatide-sMTS (Patheon)

Kindeva sMTS 5 min, then Patheon sMTS 7 min, then Patheon sMTS 5 min, then Patheon sMTS 4 min

Experimental group

Description:

Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. The abaloparatide-sMTS is manufactured at Patheon (sterile environment) or Kindeva (low bioburden environment).

Treatment:

Combination Product: abaloparatide-sMTS (Patheon)

Combination Product: abaloparatide-sMTS (Patheon)

Combination Product: abaloparatide-sMTS (Kindeva)

Combination Product: abaloparatide-sMTS (Patheon)

Patheon sMTS 4 min, then Patheon sMTS 5 min, then Patheon sMTS 7 min, then Kindeva sMTS 5 min

Experimental group

Description:

Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. The abaloparatide-sMTS is manufactured at Patheon (sterile environment) or Kindeva (low bioburden environment).

Treatment:

Combination Product: abaloparatide-sMTS (Patheon)

Combination Product: abaloparatide-sMTS (Patheon)

Combination Product: abaloparatide-sMTS (Kindeva)

Combination Product: abaloparatide-sMTS (Patheon)

Patheon sMTS 7 min, then Patheon sMTS 4 min, then Kindeva sMTS 5 min, then Patheon sMTS 5 min

Experimental group

Description:

Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. The abaloparatide-sMTS is manufactured at Patheon (sterile environment) or Kindeva (low bioburden environment).

Treatment:

Combination Product: abaloparatide-sMTS (Patheon)

Combination Product: abaloparatide-sMTS (Patheon)

Combination Product: abaloparatide-sMTS (Kindeva)

Combination Product: abaloparatide-sMTS (Patheon)