A Study of TeriQ Patch in Healthy Adult Female Participants

Last updated: December 3, 2024
Sponsor: QuadMedicine
Overall Status: Active - Recruiting

Phase

1

Condition

Osteoporosis

Treatment

TeriQ Patch

Teribone Inj.

Forteo Inj.

Clinical Study ID

NCT06644040
QD-TRP-101
  • Ages 18-60
  • Female
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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, highlyeffective method of contraception (as defined below) in the case of heterosexualintercourse. Participants in an exclusive same-sex relationship are not required toadhere to contraceptive requirements. (However, they must not attempt pregnancy withdonor eggs/sperm):

  • For the female, established hormonal contraception (oral contraceptive pills [OCPs], long-acting implantable hormones, injectable hormones, hormonalintrauterine system (IUS), or the vaginal ring) with the use of a condom forthe male partner from 30 days prior to dosing and for at least 90 days afterthe last IP administration.

  • For the female, an intrauterine device (IUD) placed 30 days prior to firstdosing and for at least 90 days after the last IP administration, with the useof a condom for the male partner.

  • For the female, surgical sterilization (with documented evidence or verbalconfirmation) at least 6 months prior to Screening (eg, bilateral tubalocclusion, complete hysterectomy, bilateral salpingectomy, or bilateraloophorectomy, tubal ligation).

  • For the male partner, a vasectomy at least 90 days prior to enrollment (withappropriate post vasectomy documentation or verbal confirmation of the absenceof 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/Lat Screening for amenorrheic female subjects, at the discretion of theInvestigator, or subject considered to be of childbearing potential.

  • Women of childbearing potential (WOCBP) must have a negative pregnancy test atScreening and Day -1 and be willing to have additional pregnancy tests asrequired throughout the study.

  • For the female, total abstinence from heterosexual intercourse, if this istheir usual practice, for 30 days prior and for 90 days after the last studytreatment is acceptable. Periodic abstinence (eg, calendar, ovulation,symptothermal, post ovulation methods) and withdrawal are not acceptable formsof contraception.

  1. Those who have received and fully understand a detailed explanation of this study,voluntarily decide to participate, and agree in writing to comply with theprecautions.

Exclusion

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 thediscretion 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 ofthe bone),

  • Previous radiation therapy history, or Patients with history of or currentskeletal malignancies or bone metastases.

  • Chronic kidney disease, autoimmune disorders, systemic corticosteroid use,hyperparathyroidism and urinary stones.

  1. Those who demonstrate any of the following results from laboratory tests (laboratorytests 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 correctedvalue,
  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) [iffemale],

  • QTcF > 470 msec,

  • Increase of alkaline phosphatase (> 1.5 x ULN),

  • PTH > 2.65pmol/L with abnormal high corrected Ca (as defined above).

  1. Subjects whose blood pressure measured at the Screening visit or at pre dose fallsunder the range below or subjects with orthostatic hypotension (ie, drop of 20 mmHgsystolic 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. Bloodpressure assessments may be repeated twice if deemed appropriate by theInvestigator.

  1. Those who used any prescription medications, within 14 days of IMP administrationare excluded, however hormonal contraceptives are considered an exception.

  2. Those who use any medical preparations (including over the counter [OTC] drugs,herbal medications, and nutritional and vitamin supplements within 7 days of IMPadministration are excluded; however, short term, episodic use up to 4g dailyparacetamol is permitted.

  3. Those who are unable to eat clinic-provided standard meals. Specific dietaryrequirements (such as vegan/vegetarian options or halal alternatives) are acceptableat the discretion of the Investigator.

  4. Those who have donated blood or plasma of approximately 500 mL within 90 days of theIMP administration, or those who have received a blood transfusion within 1 monthprior to the date of administration.

  5. 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 lastdose of IMP).

  6. Those who consume excessive amounts of caffeine (ie, more than 5 cups of coffee orequivalent per day) and are unable to abstain from consumption of caffeine productsduring the study period.

  7. Those who consume excessive amounts of alcohol (ie, more than 14 standard drinks perweek) or those who are heavy smokers (consuming more than 5 cigarettes or equivalentper day) and are unable to abstain from consuming alcohol or tobacco products from 3days prior to study drug administration and during the study.

  8. Those who are deemed by the Investigator to be unsuitable for participation in thestudy due to laboratory test results or other reasons (e.g., failure to comply withrequests and instructions, uncooperative behavior).

  9. Those with tattoos or other skin marks or blemishes at the IP application site thatmay, in the opinion of the Investigator, interfere with the ability to perform alocal assessment of skin reactions.

  10. 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.

  11. Pregnant women and nursing mothers.

  12. Those who tested positive for HBsAg, HBcAb, anti-HCVAb, anti-HIVAb, and syphilis (VDRL).

Study Design

Total Participants: 24
Treatment Group(s): 3
Primary Treatment: TeriQ Patch
Phase: 1
Study Start date:
October 25, 2024
Estimated Completion Date:
May 31, 2025

Study 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.

Connect with a study center

  • Linear Clinical Research

    Joondalup, Western Australia 6027
    Australia

    Active - Recruiting

  • Linear Clinical Research Ltd.

    Joondalup, Western Australia 6027
    Australia

    Active - Recruiting

  • Linear Clinical Research

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • Linear Clinical Research Ltd.

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

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