The main purpose of this study is to assess the safety, tolerability and potential immune response to romosozumab following single subcutaneous (SC; injection under the skin) dose administration in healthy postmenopausal Japanese and non-Japanese women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
31
Administered by subcutaneous injection
Administered by subcutaneous injection
Number of Participants With Adverse Events
A serious adverse event (SAE) is defined as an adverse event that * is fatal * is life threatening * requires in-patient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * is a congenital anomaly/birth defect * other significant medical hazard. A treatment-related AE is any treatment-emergent AE that per investigator review has a reasonable possibility of being caused by the investigational product.
Time frame: Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments.
Number of Participants Who Developed Anti-romosozumab Binding Antibodies
Participants who were negative for anti-romosozumab binding antibodies at baseline with a positive result at any time post-baseline.
Time frame: Day 29, and end of study (day 57 for participants assigned to 1 or 3 mg/kg romosozumab/placebo or day 85 for participants assigned to 5 mg/kg romosozumab/placebo)
Serum Calcium Levels
Time frame: Baseline, days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85
Serum Intact Parathyroid Hormone (iPTH) Levels
Time frame: Baseline and days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85
Maximum Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)
Time frame: Baseline and days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85
Maximum Percent Change From Baseline in Serum C-telopeptide (CTX)
Time frame: Baseline and days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85
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Percent Change From Baseline in Sclerostin
Time frame: Baseline and days 12, 29, 43, 57, 71, and 85
Time to Maximum Observed Concentration of Romosozumab
Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.
Time frame: Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.
Maximum Observed Concentration of Romosozumab
Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.
Time frame: Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.
Area Under the Serum Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Romosozumab
Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.
Time frame: Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.
Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) for Romosozumab
Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.
Time frame: Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.
Apparent Clearance (CL/F) of Romosozumab
Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.
Time frame: Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.
Half-life Associated With Beta (Plateau) Phase of Elimination (T1/2,β) for Romosozumab
Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.
Time frame: Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.
Half-life Associated With Gamma (Terminal) Phase of Elimination (T1/2,ɣ) for Romosozumab
Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.
Time frame: Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.