NCT06644040

A Study of TeriQ Patch in Healthy Adult Female Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: QuadMedicine · Industry
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Osteoporosis

Interventions

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

Timeline

• Start date: 2024-10-25
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2024-10-16
• Last updated: 2025-07-25

Locations

2 sites across 1 country: Australia