Investigating LAE102 in postmenopausal women

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Phase 1 Study to Determine the Safety, Tolerability and Pharmacokinetics of LAE102 in Healthy Postmenopausal Women

This study is testing a new drug called LAE102 in healthy postmenopausal women to see how safe it is and how the body handles it compared to a placebo.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 45 Years to 75 Years
• Sex: Female
• Sponsor: Laekna Limited (Industry-sponsored)
• Locations: 1 site (Daytona Beach, Florida)
• Trial ID: NCT06908707 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, and pharmacokinetics of LAE102 in healthy postmenopausal women. It is a placebo-controlled trial that involves administering single ascending doses of LAE102 via subcutaneous and intravenous routes. A total of at least 32 participants will be enrolled, divided into four cohorts, with a randomization ratio of 6:2 for LAE102 to placebo. The study aims to gather important data on how the drug is processed in the body and its safety profile.

Who should consider this trial

Good fit: Ideal candidates are healthy postmenopausal women aged 45 to 75 with specific health criteria.

Not a fit: Patients with significant medical conditions or a history of malignancy within the past 5 years may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into a new treatment option for postmenopausal women.

How similar studies have performed: While this approach is not widely tested, similar studies have shown promise in evaluating new treatments for postmenopausal conditions.

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.

Where this trial is running

Daytona Beach, Florida

• Fortrea Clinical Trials — Daytona Beach, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Dr. Hugh Coleman, MD — Fortrea Clinical Research Unit Inc.
• Study coordinator: Juan LIU, PHD

Conditions Postmenopausal; Healthy Adult Female Participants; Postmenopausal Women