Bioequivalence Study of SAL001 and FORSTEO in Healthy Chinese Adults

NCT04747392 | Completed Phase 1

• 1 other identifier: SAL001A101
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, randomized, open label, single-dose, the original drug controlled, crossover design, two sequence, two periods, Phase Ⅰclinical study. 64 qualified subjects will be randomly assigned to two administration sequences (sequence A and sequence B) at the ratio of 1∶1, with 32 subjects in each sequence. Each period will be given subcutaneous injection once, and the washout period will be 72 hours, and each subject will be given subcutaneous injection twice. Sequence A: the test drug (SAL001) is injected in the first period, and the reference drug (FORSTEO) is injected in the second period. Sequence B: the reference drug (FORSTEO) is injected in the first period, and the test drug (SAL001) is injected in the second period. If the geometric mean ratio (GMR) 90% confidence interval of the major pharmacokinetic indexes (AUC0-t, Cmax) for SAL001 and FORSTEO is between 80.00% and 125.00%, the two drugs are considered to be bioequivalent.

Conditions

Postmenopausal Osteoporosis

Keywords

Teriparatide; Bioequivalence

Outcome Measures

Primary Outcomes (2)

• PK parameters: area under the plasma concentration time curve from-time zero to time t (AUC0-t)

  Central lab will be used to detect the plasma concentration of drugs.

  Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4

• PK parameters: peak plasma concentration (Cmax)

  Central lab will be used to detect the plasma concentration of drugs.

  Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4

Secondary Outcomes (14)

• PK parameters: area under the plasma concentration time curve from time zero to time infinity (AUC0-∞)

  Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4

• PK parameters: time to reach peak drug concentration (Tmax)

  Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4

• PK parameters: half-life (t1/2)

  Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4

• PK parameters: AUC extrapolated from Tmax to infinity in percentage of the total AUC (AUC%extrap)

  Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4

• PK parameters: time to last measurable concentration (Tlast)

  Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4

Study Arms (2)

Sequence A

OTHER

The test drug (SAL001) is administrated once by subcutaneous injection in the first period, and the reference drug (FORSTEO) is administrated once by subcutaneous injection in the second period.

Biological: SAL001; Biological: FORSTEO

Sequence B

OTHER

The reference drug (FORSTEO) is administrated once by subcutaneous injection in the first period, and the test drug (SAL001) is administrated once by subcutaneous injection in the second period.

Biological: SAL001; Biological: FORSTEO

Interventions

SAL001 BIOLOGICAL

administrated once by subcutaneous injection

Sequence A; Sequence B

FORSTEO BIOLOGICAL

administrated once by subcutaneous injection

Sequence A; Sequence B

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Those who volunteer to participate in the trial and sign the informed consent form.
• Healthy Chinese male or female adults, the number of single sex volunteers is no less than 1/3, aged 20 to 50 years old (including the boundary value).
• Males weighted ≥50kg, females weighted ≥45kg, body mass index (BMI) between 19-25 kg/m\^2 (including boundary value), BMI= weight (kg)/height\^2 (m\^2).

You may not qualify if:

• The existence of clinically significant diseases of heart, liver, lung, kidney, digestive tract, endocrine, metabolic and hematological systems.
• history of parathyroid disease, or abnormal PTH with clinically significance judged by investigators.
• Physical examination, laboratory examination, electrocardiogram (ECG), chest radiograph, abdominal ultrasound san(digestive system, urinary system), vital signs, etc., indicate that the subject has clinically significant abnormalities judged by the investigator.
• Serum total calcium \> upper limit of normal according to the normal range of the center, or previous hypercalcemia.
• Hyperuricemia, or a previous history of gout, or abnormal blood uric acid with clinically significance judged by investigators at the time of screening.
• Those with active urolithiasis.
• Those who had received anti-osteoporosis agents (such as bisphosphonates, calcitonin, estrogen, selective estrogen receptor modulator, parathyroid hormone and its analogues, strontium salts, active vitamin D and its analogues, vitamin K2, etc.) within 6 months before the first administration of the trial.
• Those who had received oral or intravenous administration of glucocorticoids 3 months before the first administration of the trial.
• Those who had taken any drug within 14 days before the first administration of the trial.
• Allergies, such as allergic to two or more kinds of drugs or food; or known allergic to this drug components.
• Alcoholism within 1 year before screening (drinking more than 3 times a day or more than 7 times a week, drinking 1 time =150mL red wine, or 360mL beer, or 50mL white wine), or a positive alcohol breath test.
• A history of drug abuse within 1 year before screening, or a positive urine test for drugs at screening.
• Those who were smoking more than 5 cigarettes a day within 3 months before screening.
• Those who had participated in any other clinical trial within 3 months before the first administration of the trial.
• Those who had blood donation or blood loss ≥400mL within 3 months before the first administration of the trial.

Sponsors & Collaborators

• Shenzhen Salubris Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

The Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

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

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 10, 2021
• Study Start: August 19, 2020
• Primary Completion: October 30, 2020
• Study Completion: November 11, 2020
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)