A Comparison Study of PF708 and Forteo in Healthy Subjects

Pfenex

Status and phase

Completed

Phase 1

Conditions

Osteoporosis

Treatments

Drug: Teriparatide

Study type

Interventional

Funder types

Industry

Identifiers

NCT02656810

PF708-101

Details and patient eligibility

About

The purpose of this study is to compare the pharmacokinetics (blood levels) of two teriparatide products, PF708 and Forteo, in healthy subjects.

Full description

This is a double-masked, randomized, two-treatment cross-over study in healthy adult subjects. Half of the subjects will be randomized to receive PF708 first and Forteo second (Sequence A), and the other half will be randomized to receive the drugs in reverse sequence (Sequence B),

Enrollment

70 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female aged 18-50 years at the time of Informed Consent.
Able to understand and sign the written Informed Consent Form (ICF).

Exclusion criteria

History of or positive test result for human immunodeficiency virus (HIV), hepatitis C virus [test for hepatitis C virus antibody (HCV Ab)] or hepatitis B virus [test for hepatitis B surface antigen (HBsAg)].
Female subjects who are pregnant or have a positive pregnancy test result, currently breastfeeding, or planning to become pregnant during the course of the study.
Blood donation (greater than or equal to 500 mL) within 30 days prior to screening.
History of Paget's disease of bone.
History of prior external beam or implant radiation therapy involving the skeleton.
Active urolithiasis or primary hyperparathyroidism.
History of alcohol or substance abuse within 3 years prior to screening.
Previous treatment, including for investigational purposes, with any products (e.g., Forteo, Natpara) derived from human parathyroid hormone (PTH).