A Comparison Study of PF708 and Forteo in Healthy Subjects

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfenex, Inc
• Treatments: Teriparatide

Criteria

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).