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| Name | Class |
|---|---|
| Yifan Pharmaceutical (Shanghai) Co., Ltd. | UNKNOWN |
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The main aim of the study is to evaluate the pharmacokinetic (PK) biosimilarity of B-3E07 and European Union (EU) - sourced Forsteo® in healthy adult female participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: B-3E07 Followed by Forsteo ® | Experimental | Participants will receive the B-3E07 as a single subcutaneous (SC) injection on Day 1 of Period 1 followed by the Forsteo® on Day 1 of Period 2. There will be a 14-day washout between each dosing (Day 1 of each period) and a follow-up of 14-days after the last dose. |
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| Sequence 2: Forsteo® Followed by B-3E07 | Active Comparator | Participants will receive the Forsteo® as a single SC injection on Day 1 of Period 1 followed by the B-3E07 on Day 1 of Period 2. There will be a 14-day washout between each dosing (Day 1 of each period) and a follow-up of 14-day after the last dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Forsteo® | Biological | Forsteo® will be administered as SC injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of B-3E07 | Treatment Periods 1 and 2: Day 1 - Pre-dose and up to 6 hours post-dose | |
| Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC 0-inf) of B-3E07 | Treatment Periods 1 and 2: Day 1 - Pre-dose and up to 6 hours post-dose | |
| Cmax of Forsteo® | Treatment Periods 1 and 2: Day 1 - Pre-dose and up to 6 hours post-dose | |
| AUC 0-inf of Forsteo® | Treatment Periods 1 and 2: Day 1 - Pre-dose and up to 6 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time Curve up to Time t (AUC 0-t) of B-3E07 and Forsteo® | Treatment Periods 1 and 2: Day 1 - Pre-dose and up to 6 hours post-dose | |
| Time to Attain Maximal Plasma Concentration (Tmax) of B-3E07 and Forsteo® | Treatment Periods 1 and 2: Day 1 - Pre-dose and up to 6 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Benjamin Snyder, MBBS, FRACP | Contact | 613 8736 1750 | bensnyder@veritusresearch.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veritus Research | Recruiting | Bayswater | Victoria | 3153 | Australia |
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| ID | Term |
|---|---|
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| B-3E07 | Biological | B-3E07 will be administered as SC injection. |
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| Terminal Elimination Half-life (t1/2) of B-3E07 and Forsteo® | Treatment Periods 1 and 2: Day 1 - Pre-dose and up to 6 hours post-dose |
| Volume of Distribution (Vz/F) of B-3E07 and Forsteo® | Treatment Periods 1 and 2: Day 1 - Pre-dose and up to 6 hours post-dose |
| Apparent Clearance (CL/F) of B-3E07 and Forsteo® | Treatment Periods 1 and 2: Day 1 - Pre-dose and up to 6 hours post-dose |
| Maximum Observed Effect (Emax) of B-3E07 and Forsteo® | Treatment Periods 1 and 2: Pre-dose and up to 24 hours post-dose |
| Area Under the Effect-time Curve to the Last Measurable Time Point (AUEC 0-t) of B-3E07 and Forsteo® | Treatment Periods 1 and 2: Pre-dose and up to 24 hours post-dose |
| Time to Attain Maximal Serum Concentration (Tmax) of B-3E07 and Forsteo® | Treatment Periods 1 and 2: Pre-dose and up to 24 hours post-dose |
| Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | From baseline up to End of Study (EOS)/ Early termination (ET) (up to 53 days) |
| Number of Participants With Injection Site Reactions | Baseline up to 14 days |
| Number of Participants With Clinically Significant Changes in Vital Signs, 12-lead Electrocardiograph (ECG), Physical Examinations, and Laboratory Test Results | From baseline up to EOS/ ET (up to 53 days) |
| Percentage of Participants With Positive Antidrug antibodies (ADA) and ADA Titers to B-3E07 and Forsteo® | Baseline up to 14 days |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |