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

NCT06908707 | Completed Phase 1 FDA Drug

• 1 other identifier: LAE102INT1003
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postmenopausal; Healthy Adult Female Participants

Keywords

Postmenopausal Women

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• To evaluate the Maximum Concentration (Cmax) of LAE102 in healthy postmenopausal women following a single IV or SC dose

  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

  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

  Predose up to 8 weeks

Study Arms (4)

LAE102 SC

EXPERIMENTAL

Participants will receive a single dose by SC administration (3 dose levels)

Drug: LAE102 SC

Placebo SC

PLACEBO COMPARATOR

Participants will receive a single dose by SC administration

Drug: Placebo SC

LAE102 IV

EXPERIMENTAL

Participants will receive a single IV dose (1 dose level)

Drug: LAE102 IV

Placebo IV

PLACEBO COMPARATOR

Participants will receive a single IV dose

Drug: Placebo IV

Interventions

LAE102 SC DRUG

A single dose of LAE102 will be administered subcutaneously

Also known as: LAE102

LAE102 SC

Placebo SC DRUG

A single dose of placebo administered subcutaneously

Also known as: Placebo

Placebo SC

LAE102 IV DRUG

A single dose of LAE102 administered intravenously

Also known as: LAE102

LAE102 IV

Placebo IV DRUG

A single dose of placebo administered intravenously

Also known as: Placebo

Placebo IV

Eligibility Criteria

• Age: 45 Years - 75 Years
• Gender Eligibility Details: Females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laekna Limited: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Fortrea Clinical Trials

Daytona Beach, Florida, 32117, United States

Location

Study Officials

• Dr. Hugh Coleman, MD

  Fortrea Clinical Research Unit Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: April 22, 2025
• Primary Completion: October 23, 2025
• Study Completion: October 23, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

US (1)