CompletedPhase 1

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

United States32 participantsStarted 2025-04-22

Plain-language summary

The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of LAE102 in healthy postmenopausal women

Who can participate

Age range45 Years – 75 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 inte…

What they're measuring

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

Timeframe: 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

Timeframe: Baseline up to 8 weeks

Trial details

NCT IDNCT06908707

SponsorLaekna Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-23

View on ClinicalTrials.gov More Postmenopausal trials

Who can participate

Age range45 Years – 75 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 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

Timeframe: Baseline up to 8 weeks