COMPLETED

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

Conditions

Postmenopausal Healthy Adult Female Participants Postmenopausal Women

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-04-22

Study Completion:2025-10-23

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06908707

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 75 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Dr. Hugh Coleman, MD

PRINCIPAL_INVESTIGATOR

Fortrea Clinical Research Unit Inc.

Study Locations (Sites)

Fortrea Clinical Trials

Daytona Beach, Florida, 32117

United States

Collaborators and Investigators

Sponsor: Laekna Limited

Dr. Hugh Coleman, MD, PRINCIPAL_INVESTIGATOR, Fortrea Clinical Research Unit Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-22

Study Completion Date2025-10-23

Study Record Updates

Study Start Date2025-04-22

Study Completion Date2025-10-23

Terms related to this study

Keywords Provided by Researchers

Postmenopausal Women

Additional Relevant MeSH Terms

Postmenopausal
Healthy Adult Female Participants