CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
rhPTH(1-84) +2 moredrug
Likely dose
rhPTH(1-84) 25 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03150108
NCT03150108Phase 1Completed

A Phase 1, Open-label, Randomized, Cross-over Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Dose of rhPTH(1-84) Administered Subcutaneously in Japanese Healthy Subjects Compared With Matched Non-Hispanic, Caucasian Healthy Adult Subjects and to Assess Dose Proportionality of 3 Doses of rhPTH(1-84) in the Japanese Subjects

Shire·interventional·Posted May 12, 2017·Updated Jun 8, 2021

In Brief

A Phase 1 clinical trial evaluating rhPTH(1-84) for Hypoparathyroidism. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedMay 12, 2017
Enrollment StartMay 16, 2017
Primary CompletionJun 26, 2017
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 9.1 years ago

Interventions

rhPTH(1-84)drug

25 mcg rhPTH(1-84) SC injection

rhPTH(1-84)drug

50 mcg rhPTH(1-84) SC injection

rhPTH(1-84)drug

100 mcg rhPTH(1-84) SC injection