A Phase II Clinical Trial of the Safety and Efficacy of SAL056 at Different Doses and Dosing Regimens

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age45-80
SponsorShenzhen Salubris Pharmaceuticals Co., Ltd.

About this trial

This is a multicenter, randomized, open-label, parallel-controlled Phase II study designed to evaluate the differences in safety among four different dosing regimens of SAL056.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Received teriparatide treatment within 1 month prior to screening;

Patients with secondary osteoporosis, such as Cushing's syndrome, hyperprolactinemia, malabsorption syndrome or various gastrointestinal diseases related to malabsorption (such as Crohn's disease, chronic pancreatitis, etc.), rheumatoid arthritis, gout, multiple myeloma, etc.;

Patients with other diseases affecting calcium or bone metabolism, including hyperparathyroidism or hypoparathyroidism, hyperthyroidism or hypothyroidism (patients with hyperthyroidism or hypothyroidism receiving stable treatment with normal hormone levels are eligible; or patients with hypothyroidism where 5.5 mIU/L < thyroid-stimulating hormone ≤ 10.0 mIU/L but free thyroxine is within normal range are eligible), osteogenesis imperfecta, osteomalacia, Paget's disease of bone, hypercalcemia, hypocalcemia, active urolithiasis, etc.;

Patients who require treatment with other anti-osteoporosis drugs during the trial or long-term/continuous use of digitalis glycosides such as digoxin;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SAL056 56.5μg

    Drug

    SAL056 56.5μg administered once weekly for 8 weeks

  • Intervention Group 1

    Drug

    Teriparatide Injection daily formulation administered for 2 weeks, followed by SAL056 for 6 weeks.

  • Intervention Group 2

    Drug

    Teriparatide Injection daily formulation administered for 4 weeks, followed by SAL056 for 4 weeks.

  • Intervention Group 3

    Drug

    SAL056 28.2μg administered twice weekly for 8 weeks.

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: Control groupExperimental treatment 1 intervention
Group B: Intervention Group 1Other 1 intervention
Group C: Intervention Group 2Other 1 intervention
Group D: Intervention Group 3Other 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) between each intervention group and the control group during the treatment period,about 10weeks

Time frame
during the treatment period,about 10 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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Shenzhen Salubris Pharmaceuticals Co., Ltd.

Lead sponsor

Salubris (Suzhou) Pharmaceutical Co., Ltd.

Collaborator