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A Study of TeriQ Patch in Healthy Adult Female Participants

PHASE1NOT_YET_RECRUITING

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

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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: * 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.

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.

Exclusion criteria

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. * 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 1. Serum albumin < 40 g/L: corrected using the following formula, 2. Serum albumin ≥ 40 g/L: measured value will be deemed to be the corrected value, 3. 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 > 25 pg/mL with abnormal high corrected Ca (as defined above).

Subjects whose blood pressure measured at the Screening visit or at predose 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.

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.

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).

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : Yes

Gender eligible for study: Female

Things to know

Study dates

Study start: 2024-11-19

Primary completion: 2024-12-30

Study completion finish: 2025-01-31

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT06644040

Intervention or treatment

DRUG: TeriQ Patch

DRUG: Teribone Inj.

DRUG: Forteo Inj.

Conditions

• Osteoporosis

Condition: Osteoporosis
DRUG: TeriQ Patch and other drugs
Nedlands, South Australia, Australia
Sponsor: QuadMedicine

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Linear Clinical Research

Research sites nearby

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Linear Clinical Research
Nedlands, South Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: TeriQ Patch Not Specified	DRUG: TeriQ Patch 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
ACTIVE_COMPARATOR: Teribone Injection Not Specified	DRUG: Teribone Inj. Participants may receive either one single dose Teribone Inj. or Forteo Inj. following TeriQ patch. Route of administration: Sub-cutaneous Injection
ACTIVE_COMPARATOR: Forteo Injection Not Specified	DRUG: Forteo Inj. Participants may receive either one single dose Teribone Inj. or Forteo Inj. following TeriQ patch. Route of administration: Sub-cutaneous Injection

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
To evaluate the pharmacokinetic (PK) endpoints of teriparatide following a single dose administration of TeriQ Patch- Maximum plasma concentration (Cmax)	Not Specified	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)	Not Specified	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)	Not Specified	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	Not Specified	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)	Not Specified	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)	Not Specified	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)	Not Specified	12 timepoints on baseline up to 8 hours post first dose administration

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
To evaluate the safety and tolerability of teriparatide by number of participants with treatment related adverse events (TEAEs)	Not Specified	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.	Not Specified	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.	3 timepoints on baseline post first dose administration (predose, 4hours and 8 hours after dosing)

Frequently Asked Questions

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References

Clinical Trials Gov: A Study of TeriQ Patch in Healthy Adult Female Participants