Trials / Unknown
UnknownNCT03720886
G56W1 in Women With Postmenopausal Osteoporosis
Two-dose, Positive Drug Control, Multicentre, Randomized, Double-blind Study of Recombinant Human Parathyroid Hormone for Injection(rhPTH)(1-34) Once a Week to Treat Postmenopausal Osteoporosis Women for the Evaluation the Pharmacokinetics and Safety and to Explore Therapeutic Effects
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 148 (estimated)
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd. · Industry
- Sex
- All
- Age
- 45 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study will assess the pharmacokinetics and safety and explore therapeutic effects with once-weekly recombinant human parathyroid hormone for injection ( 1-34 ) ( G56W1 ) in women with post-menopausal osteoporosis .The anticipated time on study treatment is 24 weeks, and the target sample size is 148 individuals.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | rhPTH（1-34） 28.2μg | Administered by subcutaneous injection |
| BIOLOGICAL | rhPTH（1-34） 56.5μg | Administered by subcutaneous injection |
| BIOLOGICAL | teriparatide acetate(Teribone™) | Administered by subcutaneous injection |
Timeline
- Start date
- 2018-10-01
- Primary completion
- 2020-05-31
- Completion
- 2020-08-31
- First posted
- 2018-10-25
- Last updated
- 2018-10-25
Locations
9 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03720886. Inclusion in this directory is not an endorsement.