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A Study of TeriQ Patch in Healthy Adult Female Participants | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of TeriQ Patch in Healthy Adult Female Participants

A Randomized, Open-Label, Active-Controlled, 3-Way, Incomplete Block, Crossover, Single Escalating Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of TeriQ Patch in Healthy Adult Female Participants

NCT06644040•QuadMedicine

View on ClinicalTrials.gov

Summary

This will be a single center, open-label, active-controlled, 3-way, incomplete block, crossover, randomized, and single escalating dose study.

Detailed Description

This study will compare TeriQ Patch with two active comparators, Teribone Injection and Forteo Injection, to evaluate the safety, tolerability, and pharmacokinetics of TeriQ Patch in healthy adult female participants. This study will be a single escalating dose study in which 24 healthy adult female participants will receive 2 of the 3 TeriQ Patch dose levels (28.2 μg, 56.5 μg, and 113.0 μg) and 1 of the control drugs (Teribone Inj. or Forteo Inj.) in 3 separate time periods. 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.

Eligibility

Age

18 - 60 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy adult females aged 18 to 60 years (inclusive) at the time of Screening.
•2. Those who weigh ≥ 45 kg and have a calculated BMI of 18.0 to 32.0 kg/meter square
•3. Females must be non-pregnant and non-lactating and must use an acceptable, highly effective method of contraception (as defined below) in the case of heterosexual intercourse. Participants in an exclusive same-sex relationship are not required to adhere to contraceptive requirements. (However, they must not attempt pregnancy with donor eggs/sperm):
•* For the female, established hormonal contraception (oral contraceptive pills \[OCPs\], long-acting implantable hormones, injectable hormones, hormonal intrauterine system (IUS), or the vaginal ring) with the use of a condom for the male partner from 30 days prior to dosing and for at least 90 days after the last IP administration.
•* For the female, an intrauterine device (IUD) placed 30 days prior to first dosing and for at least 90 days after the last IP administration, with the use of a condom for the male partner.
•* For the female, surgical sterilization (with documented evidence or verbal confirmation) at least 6 months prior to Screening (eg, bilateral tubal occlusion, complete hysterectomy, bilateral salpingectomy, or bilateral oophorectomy, tubal ligation).
•* For the male partner, a vasectomy at least 90 days prior to enrollment (with appropriate post vasectomy documentation or verbal confirmation of the absence of sperm in semen), provided the male partner is a sole partner.
•* Women not of childbearing potential must be postmenopausal for ≥ 12 months. Postmenopausal status may be confirmed through testing of FSH levels ≥ 40 IU/L at Screening for amenorrheic female subjects, at the discretion of the Investigator, or subject considered to be of childbearing potential.
•* 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.
•* For the female, total abstinence from heterosexual intercourse, if this is their usual practice, for 30 days prior and for 90 days after the last study treatment is acceptable. Periodic abstinence (eg, calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable forms of contraception.
+1 more criteria

Exclusion Criteria

•1. Those who have or have had a history of clinically significant cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immune, dermatologic, neurologic, active chronic condition or psychiatric disorders.
•2. 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.
•3. Those who have a medical condition that may affect the absorption, distribution, metabolism, or excretion of drugs.
•4. Those who have any of the following conditions:
•* Metabolic bone disease (including hyperparathyroidism and Paget's disease of the bone),
•* Previous radiation therapy history, or Patients with history of or current skeletal malignancies or bone metastases.
•* Chronic kidney disease, autoimmune disorders, systemic corticosteroid use, hyperparathyroidism and urinary stones.
•5. Those who demonstrate any of the following results from laboratory tests (laboratory tests may be repeated once if deemed appropriate by the Investigator):
•* Corrected serum Ca concentration \> 2.7mmol/L
•1. Serum albumin \< 40 g/L: corrected using the following formula,
+23 more criteria

Locations (2)

Linear Clinical Research Ltd.

Joondalup, Western Australia, Australia

Linear Clinical Research Ltd.

Nedlands, Western Australia, Australia

Key Dates

Start Date

October 25, 2024

Primary Completion Date

December 30, 2024

Completion Date

December 30, 2024

Last Updated

July 25, 2025

Enrollment

ACTUAL participants

Conditions

Osteoporosis

Interventions

TeriQ Patch

DRUG

Teribone Inj.

DRUG

Forteo Inj.

DRUG

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

NCT06731608

OsteoporosisLower Limb Fracture

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RECRUITINGPHASE4

Step-down Therapy After Long-term Osteoporosis Treatment

NCT07281586

Osteoporosis

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RECRUITING

Smart Wearable Device (gaitQ): Walk Better Project

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of TeriQ Patch in Healthy Adult Female Participants

Inclusion Criteria

Exclusion Criteria

OsteoPorotic fracTure preventION System (OPTIONS) Research Study

Step-down Therapy After Long-term Osteoporosis Treatment

Smart Wearable Device (gaitQ): Walk Better Project

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