OsteoporosisPhase 1NCT06644040
A Study of TeriQ Patch in Healthy Adult Female Participants
A Phase 1 study testing TeriQ Patch, Teribone Inj. and Forteo Inj. in people with Osteoporosis, run by QuadMedicine at 2 sites in Australia.
Trial summary
This will be a single center, open-label, active-controlled, 3-way, incomplete block, crossover, randomized, and single escalating dose study. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- TeriQ Patch, Teribone Inj. and Forteo Inj.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesAustralia
- Study dates
- 25 Oct 2024to 30 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to 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
- 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).
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- 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.
- 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.
Who cannot join
- 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.
- 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:
- 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.
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- Chronic kidney disease, autoimmune disorders, systemic corticosteroid use, hyperparathyroidism and urinary stones.
- 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
- Serum albumin < 40 g/L: corrected using the following formula,
- Serum albumin ≥ 40 g/L: measured value will be deemed to be the corrected value,
- Corrected Ca: Measured Calcium [(measured Albumin- 41) *0.02]
- Individuals with a calculated creatinine clearance of 80mL/min or less
- Those whose creatinine clearance calculated with the Cockcroft-Gault formula is 80 mL/min or less
- (Creatinine Clearance = (((1.23 x weight x (140 - age))/creatinine) x 0.85) [if female],
- QTcF > 470 msec,
- Increase of alkaline phosphatase (> 1.5 x ULN),
- PTH > 2.65pmol/L with abnormal high corrected Ca (as defined above).
- Subjects whose blood pressure measured at the Screening visit or at pre dose falls under the range below or subjects with orthostatic hypotension (ie, drop of 20 mmHg systolic or 10 mmHg diastolic blood pressure):
- Systolic blood pressure: 100 mmHg or less or greater than 159 mmHg,
- Diastolic blood pressure: 60 mmHg or less or greater than 99 mmHg. Blood pressure assessments may be repeated twice if deemed appropriate by the Investigator.
- Those who used any prescription medications, within 14 days of IMP administration are excluded, however hormonal contraceptives are considered an exception.
- Those who use any medical preparations (including over the counter [OTC] drugs, herbal medications, and nutritional and vitamin supplements within 7 days of IMP administration are excluded; however, short term, episodic use up to 4g daily paracetamol is permitted.
- Those who are unable to eat clinic-provided standard meals. Specific dietary requirements (such as vegan/vegetarian options or halal alternatives) are acceptable at the discretion of the Investigator.
- Those who have donated blood or plasma of approximately 500 mL within 90 days of the IMP administration, or those who have received a blood transfusion within 1 month prior to the date of administration.
- Those who have participated in another clinical study or bioequivalence study within 30 days or 5 half-lives (whichever is longer) of the first dose date (date of last dose of IMP).
- Those who consume excessive amounts of caffeine (ie, more than 5 cups of coffee or equivalent per day) and are unable to abstain from consumption of caffeine products during the study period.
- Those who consume excessive amounts of alcohol (ie, more than 14 standard drinks per week) or those who are heavy smokers (consuming more than 5 cigarettes or equivalent per day) and are unable to abstain from consuming alcohol or tobacco products from 3 days prior to study drug administration and during the study.
- Those who are deemed by the Investigator to be unsuitable for participation in the study due to laboratory test results or other reasons (e.g., failure to comply with requests and instructions, uncooperative behavior).
- Those with tattoos or other skin marks or blemishes at the IP application site that may, in the opinion of the Investigator, interfere with the ability to perform a local assessment of skin reactions.
- Those with a history of substance abuse or test positive for drugs of abuse (including tetrahydrocannabinol [THC], cocaine, amphetamines, barbiturates, benzodiazepines, opiates, methadone, methamphetamines, methylenedioxymethamphetamine [MDMA], and phencyclidine [PCP]) on a urine drug Screening test.
- Pregnant women and nursing mothers.
- Those who tested positive for HBsAg, HBcAb, anti-HCVAb, anti-HIVAb, and syphilis (VDRL).
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Linear Clinical Research Ltd.
Joondalup, Western Australia, 6027
Linear Clinical Research Ltd.
Nedlands, Western Australia, 6009
About this study
Official title: 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
This will be a single center, open-label, active-controlled, 3-way, incomplete block, crossover, randomized, and single escalating dose study.
Read the 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.
- Conditions
- Osteoporosis
- Being tested
- TeriQ Patch, Teribone Inj., Forteo Inj.
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriQ PatchDrug
Also called Study Drug
Participants will receive two single doses of either of the TeriQ patch (Strength- 28.2 µg, 56.5 µg, and 113.0 µg) approximately 1 week apart.
Route of administration- Dermal patch
Teribone Inj.Drug
Also called Control Drug 1
Participants may receive either one single dose Teribone Inj. or Forteo Inj. following TeriQ patch.
Route of administration: Sub-cutaneous Injection
Forteo Inj.Drug
Also called Control Drug 2
Participants may receive either one single dose Teribone Inj. or Forteo Inj. following TeriQ patch.
Route of administration: Sub-cutaneous Injection
| Study group | Role | What they receive |
|---|---|---|
| TeriQ Patch | Experimental | Not described Receives: Drug: TeriQ Patch |
| Teribone Injection | Active comparator | Not described Receives: Drug: Teribone Inj. |
| Forteo Injection | Active comparator | Not described Receives: Drug: Forteo Inj. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the pharmacokinetic (PK) endpoints of teriparatide following a single dose administration of TeriQ Patch- Maximum plasma concentration (Cmax)
Measured: 12 timepoints on baseline up to 8 hours post first dose administration
To evaluate the pharmacokinetic (PK) endpoints of teriparatide following a single dose administration of TeriQ Patch- Time for maximum plasma concentration (Tmax)
Measured: 12 timepoints on baseline up to 8 hours post first dose administration
To evaluate the pharmacokinetic (PK) endpoints of teriparatide following a single dose administration of TeriQ Patch- Area under curve (AUC)
Measured: 12 timepoints on baseline up to 8 hours post first dose administration
To evaluate the pharmacokinetic (PK) endpoints of teriparatide following a single dose administration of TeriQ Patch- half life
Measured: 12 timepoints on baseline up to 8 hours post first dose administration
To evaluate the pharmacokinetic (PK) endpoints of teriparatide following a single dose administration of TeriQ Patch- Clearance (CL/F)
Measured: 12 timepoints on baseline up to 8 hours post first dose administration
To evaluate the pharmacokinetic (PK) endpoints of teriparatide following a single dose administration of TeriQ Patch- Volume distribution (Vd/F)
Measured: 12 timepoints on baseline up to 8 hours post first dose administration
To evaluate the pharmacokinetic (PK) endpoints of teriparatide following a single dose administration of TeriQ Patch- Mean residence rate (MRT)
Measured: 12 timepoints on baseline up to 8 hours post first dose administration
Secondary outcomes (3)
To evaluate the safety and tolerability of teriparatide by number of participants with treatment related adverse events (TEAEs)
Measured: Screening to approximately 4 weeks post first dose administration
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment.
Measured: Screening to approximately 4 weeks post first dose administration
Number of participants with changes to local stimulus response rate.
Local stimulus response test will be performed for the following items (pain, redness, swelling, itching, and hardness) before each administration. (within 60 minutes) and 4 and 8 hours after administration.
Measured: 3 timepoints on baseline post first dose administration (predose, 4hours and 8 hours after dosing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start25 Oct 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- QuadMedicine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644040
- Sponsor's protocol ID
- QD-TRP-101
- Status last verified
- Jul 2025
- First submitted
- 7 Oct 2024
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06644040
- Acronym / sponsor ID
- QD-TRP-101
- Conditions
- Osteoporosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- QuadMedicineIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TeriQ Patch | Experimental | Drug: TeriQ Patch |
| Teribone Injection | Active comparator | Drug: Teribone Inj. |
| Forteo Injection | Active comparator | Drug: Forteo Inj. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
- 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):
- 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.
Key exclusion criteria (33 listed)
- 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.
- 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:
- Those who demonstrate any of the following results from laboratory tests (laboratory tests may be repeated once if deemed appropriate by the Investigator):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeriQ PatchAlso: Study DrugParticipants will receive two single doses of either of the TeriQ patch (Strength- 28.2 µg, 56.5 µg, and 113.0 µg) approximately 1 week apart. Route of administration- Dermal patch | Drug | TeriQ Patch |
| Teribone Inj.Also: Control Drug 1Participants may receive either one single dose Teribone Inj. or Forteo Inj. following TeriQ patch. Route of administration: Sub-cutaneous Injection | Drug | Teribone Injection |
| Forteo Inj.Also: Control Drug 2Participants may receive either one single dose Teribone Inj. or Forteo Inj. following TeriQ patch. Route of administration: Sub-cutaneous Injection | Drug | Forteo Injection |
Primary outcome
To evaluate the pharmacokinetic (PK) endpoints of teriparatide following a single dose administration of TeriQ Patch- Maximum plasma concentration (Cmax)
Time frame: 12 timepoints on baseline up to 8 hours post first dose administration
To evaluate the pharmacokinetic (PK) endpoints of teriparatide following a single dose administration of TeriQ Patch- Time for maximum plasma concentration (Tmax)
Time frame: 12 timepoints on baseline up to 8 hours post first dose administration
To evaluate the pharmacokinetic (PK) endpoints of teriparatide following a single dose administration of TeriQ Patch- Area under curve (AUC)
Time frame: 12 timepoints on baseline up to 8 hours post first dose administration
To evaluate the pharmacokinetic (PK) endpoints of teriparatide following a single dose administration of TeriQ Patch- half life
Time frame: 12 timepoints on baseline up to 8 hours post first dose administration
To evaluate the pharmacokinetic (PK) endpoints of teriparatide following a single dose administration of TeriQ Patch- Clearance (CL/F)
Time frame: 12 timepoints on baseline up to 8 hours post first dose administration
To evaluate the pharmacokinetic (PK) endpoints of teriparatide following a single dose administration of TeriQ Patch- Volume distribution (Vd/F)
Time frame: 12 timepoints on baseline up to 8 hours post first dose administration
To evaluate the pharmacokinetic (PK) endpoints of teriparatide following a single dose administration of TeriQ Patch- Mean residence rate (MRT)
Time frame: 12 timepoints on baseline up to 8 hours post first dose administration
3 secondary outcomes
To evaluate the safety and tolerability of teriparatide by number of participants with treatment related adverse events (TEAEs)
Time frame: Screening to approximately 4 weeks post first dose administration
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment.
Time frame: Screening to approximately 4 weeks post first dose administration
Number of participants with changes to local stimulus response rate.
Time frame: 3 timepoints on baseline post first dose administration (predose, 4hours and 8 hours after dosing)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TeriQ Patch, Teribone Inj. and Forteo Inj. in people with Osteoporosis, run by QuadMedicine at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the pharmacokinetic (PK) endpoints of teriparatide following a single dose administration of TeriQ Patch- Maximum plasma concentration (Cmax) (time frame: 12 timepoints on baseline up to 8 hours post first dose administration). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.