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Study of rhPTH(1-84) in Japanese Healthy Subjects Compared With Matched Caucasian Healthy Adult Subjects

NCT03150108 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-06-08

Study results available
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Summary

The purpose of this study is to compare how rhPTH(1-84) affects the body between healthy adults of Japanese descent and matched, healthy Caucasian adults.

Conditions

  • Hypoparathyroidism

Interventions

DRUG

rhPTH(1-84)

25 mcg rhPTH(1-84) SC injection

DRUG

rhPTH(1-84)

50 mcg rhPTH(1-84) SC injection

DRUG

rhPTH(1-84)

100 mcg rhPTH(1-84) SC injection

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-16
Primary Completion
2017-06-26
Completion
2017-06-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03150108 on ClinicalTrials.gov