The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of LAE102 in healthy postmenopausal women
This is a placebo-controlled single ascending dose by subcutaneous (SC) and Intravenous (IV) administration in healthy postmenopausal women to assess the safety and tolerability of LAE102. At least 32 healthy female participants will be enrolled in 4 cohorts with each cohort including 8 participants randomized 6:2 LAE102:Placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
32
A single dose of LAE102 will be administered subcutaneously
A single dose of placebo administered subcutaneously
A single dose of LAE102 administered intravenously
Fortrea Clinical Trials
Daytona Beach, Florida, United States
To evaluate the safety and tolerability (number of participants with serious adverse events (SAE)) of LAE102 in healthy postmenopausal women following a single IV or SC dose
Number of participants with SAEs \- Evaluation of Safety and Tolerability of LAE102
Time frame: Baseline up to 8 weeks
To evaluate the safety and tolerability (number of participants with treatment emergent adverse events (TEAE)) of LAE102 in healthy postmenopausal women following a single IV or SC dose
Number of participants with TEAEs \- Evaluation of Safety and Tolerability of LAE102
Time frame: Baseline up to 8 weeks
To evaluate the Maximum Concentration (Cmax) of LAE102 in healthy postmenopausal women following a single IV or SC dose
\- PK: Cmax of LAE102
Time frame: Predose up to 8 weeks
To evaluate the Area Under Curve (AUC) of LAE102 in healthy postmenopausal women following a single IV or SC dose
\- PK: AUC of LAE102
Time frame: Predose up to 8 weeks
To evaluate the Time of Maximum Serum Concentration (Tmax) of LAE102 in healthy postmenopausal women following a single IV or SC dose
\- PK: Tmax of LAE102
Time frame: Predose up to 8 weeks
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A single dose of placebo administered intravenously