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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAE102 SC | Experimental | Participants will receive a single dose by SC administration (3 dose levels) |
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| Placebo SC | Placebo Comparator | Participants will receive a single dose by SC administration |
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| LAE102 IV | Experimental | Participants will receive a single IV dose (1 dose level) |
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| Placebo IV | Placebo Comparator | Participants will receive a single IV dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAE102 SC | Drug | A single dose of LAE102 will be administered subcutaneously |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Baseline up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the Maximum Concentration (Cmax) of LAE102 in healthy postmenopausal women following a single IV or SC dose | - PK: Cmax of LAE102 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Females
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Hugh Coleman, MD | Fortrea Clinical Research Unit Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Trials | Daytona Beach | Florida | 32117 | United States |
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| Placebo SC | Drug | A single dose of placebo administered subcutaneously |
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| LAE102 IV | Drug | A single dose of LAE102 administered intravenously |
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| Placebo IV | Drug | A single dose of placebo administered intravenously |
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- PK: AUC of LAE102 |
| 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 | Predose up to 8 weeks |