A Study of TeriQ Patch in Healthy Adult Female Participants

NCT06644040 | Completed Phase 1 DMC

• 1 other identifier: QD-TRP-101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (7)

• To evaluate the pharmacokinetic (PK) endpoints of teriparatide following a single dose administration of TeriQ Patch- Maximum plasma concentration (Cmax)

  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)

  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)

  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

  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)

  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)

  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)

  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)

  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.

  Screening to approximately 4 weeks post first dose administration

• Number of participants with changes to local stimulus response rate.

  3 timepoints on baseline post first dose administration (predose, 4hours and 8 hours after dosing)

Study Arms (3)

TeriQ Patch

EXPERIMENTAL

Drug: TeriQ Patch

Teribone Injection

ACTIVE COMPARATOR

Drug: Teribone Inj.

Forteo Injection

ACTIVE COMPARATOR

Drug: Forteo Inj.

Interventions

TeriQ Patch 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

Also known as: Study Drug

TeriQ Patch

Teribone Inj. DRUG

Participants may receive either one single dose Teribone Inj. or Forteo Inj. following TeriQ patch. Route of administration: Sub-cutaneous Injection

Also known as: Control Drug 1

Teribone Injection

Forteo Inj. DRUG

Participants may receive either one single dose Teribone Inj. or Forteo Inj. following TeriQ patch. Route of administration: Sub-cutaneous Injection

Also known as: Control Drug 2

Forteo Injection

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Yes
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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
• 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) \[if female\],

Sponsors & Collaborators

• QuadMedicine: lead

Study Sites (2)

Linear Clinical Research Ltd.

Joondalup, Western Australia, 6027, Australia

Location

Linear Clinical Research Ltd.

Nedlands, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Drug Evaluation

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 16, 2024
• Study Start: October 25, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)