A Study to Investigate Safety, Tolerability and Pharmacokinetics of LAE102 in Postmenopausal Women

Launched by LAEKNA LIMITED · Mar 27, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to study the safety, tolerability, and how the body processes a new medication called LAE102 in healthy postmenopausal women. The researchers want to understand if this treatment is safe for use and how it behaves in the body. The trial is not currently recruiting participants, but when it starts, it will involve women aged 45 to 75 who are postmenopausal and meet certain health criteria. For example, participants should have a body mass index (BMI) within a specific range and certain hormone levels that indicate they are postmenopausal.

If you are eligible and decide to participate, you will need to attend several study visits where you will undergo health assessments and receive the study medication. It’s important to know that there are specific health conditions and recent medical activities that might prevent someone from joining the study, such as certain medical histories or the use of specific medications. This trial offers an opportunity to contribute to medical research while helping to evaluate a new treatment that could benefit others in the future.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Females aged 45 to 75 years of age inclusive, at time of signing the informed consent.
• • Are healthy postmenopausal female participants.
• • Have a body mass index (BMI) within the range 20.0 - 32.0kg/m\^2 inclusive at screening.
• • Have follicle stimulating hormones (FSH) levels ≥40 IU/L at screening.
• • Have clinical laboratory test results within the normal reference range for the population.
• • Have venous access sufficient to allow for blood sampling and IV administration of study intervention as per the protocol and have no anticipated contradictions to receiving investigational products via SC administration
• • Are capable of giving informed consent.
• • Are willing to make themselves available for study visits for the duration of the study and are willing to follow study procedures.
• Exclusion Criteria:
• • Have a history or presence of clinically significant medical condition(s)
• • Have a history of any malignancy within the past 5 years.
• • Have hemoglobin level at screening above the upper limit normal for females.
• • Have a fasting serum triglyceride level of more than 500mg/dL at screening.
• • Have an estimated glomerular filtration rate (eGFR) less than 60mL/min/1.73m\^2 at screening.
• • Have an abnormal electrocardiogram (ECG)
• • Have an abnormal blood pressure.
• • Show evidence at screening of HIV or Hepatitis B or C.
• • Have a history of or known drug related hypersensitivity or severe allergy
• • Underwent major surgery within 30 days prior to study intervention administration or plan to undergo major surgery during the study.
• • Have used in the past 90 days or intend to use during the study any medication that may affect FSH levels.
• • Have used or intended to use over the counter medications, and/or herbal medicines, from 14 days or 5 half-lives (if known), whichever is longer, prior to study intervention administration until the last visit.
• • Received any vaccine 30 days prior to screening or plan to receive any vaccine during the study.
• • Have participated, are currently enrolled in, or discontinued from a clinical trial involving an investigational drug or device or off-label use of a drug or device within the last 90 days, or 5-half-lives (if known, whichever is longer), of the last administration of study drug or application of the device, or any other type of medical research judged not to be scientifically or medically compatible with this study.
• • Have previously completed or withdrawn from this study or any other study investigating this study intervention.
• • Have alcohol consumption exceeding 14 units per week, a positive alcohol test at screening or administration, a history of alcohol abuse within 1 year prior to screening, or are unable to stop alcohol consumption during the study.
• • Have a known or suspected history of substance abuse or test positive for drugs of abuse at screening or admission
• • Are smoking more than 5 cigarettes (or the equivalent of other tobacco products) per day within 90 days prior to screening or are unable to stop smoking during the study.
• • Have donated blood or experienced blood loss of more than 400mL within 90 days prior to screening.
• • Are fasting or receiving weight loss treatment within 30 days prior to administration or experiencing major changes in lifestyle.
• • In the opinion of the investigator or sponsor and medical monitor, are unsuitable for inclusion in the study.