A Study of TeriQ Patch in Healthy Adult Female Participants

What Was Tested

In this phase 1 trial, researchers set out to test Teriparatide.

It had three arms (groups): TeriQ Patch (experimental), Teribone Injection (active comparator) and Forteo Injection (active comparator).

The registry classes the interventions as drug.

More on the Plan

There will be a washout period of approximately 1 week between each treatment period.

The control drug will be administered as a subcutaneous (SC) injection and the test drug will be administered as a dermal patch.

Who Took Part

The registry lists 24 actual participants took part.

It was open to women only aged from 18 years up to 60 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy adult females aged 18 to 60 years (inclusive) at the time of Screening. Those who weigh ≥ 45 kg and have a calculated BMI of 18.0 to 32.0 kg/meter square. Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and Day -1 and be willing to have additional pregnancy tests as required throughout the study. Those who have received and fully understand a detailed explanation of this study, voluntarily decide to participate, and agree in writing to comply with the precautions.

The full record lists 11 inclusion and 33 exclusion criteria; among the exclusions: those who have an acute illness within 28 days (or shorter if deemed suitable at the discretion of the investigator) of administration of the imp; those who have a medical condition that may affect the absorption, distribution, metabolism, or excretion of drugs; those who have any of the following conditions:.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Teriparatide and who got the comparison, which limits bias.

The Teriparatide group and the comparison group ran side by side rather than switching.

Being open-label, the Teriparatide study did not mask who received what.

It started in 2024-10-25 with completion listed for 2024-12-30.

It ran at 2 sites in Australia (2).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example To evaluate the safety and tolerability of teriparatide by number of participants with treatment related adverse events (TEAEs), Number of participants with abnormal laboratory values and/or adverse events that are related to treatment and Number of participants with changes to local stimulus response rate.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Teriparatide in 24 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Teriparatide compound page, all human trials.