This will be a single center, open-label, active-controlled, 3-way, incomplete block, crossover, randomized, and single escalating dose study.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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
Participants may receive either one single dose Teribone Inj. or Forteo Inj. following TeriQ patch. Route of administration: Sub-cutaneous Injection
Participants may receive either one single dose Teribone Inj. or Forteo Inj. following TeriQ patch. Route of administration: Sub-cutaneous Injection
Linear Clinical Research Ltd.
Joondalup, Western Australia, Australia
Linear Clinical Research Ltd.
Nedlands, Western Australia, Australia
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
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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.
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.
Time frame: 3 timepoints on baseline post first dose administration (predose, 4hours and 8 hours after dosing)