PostmenopausalPhase 1LAE102NCT06908707
A Study to Investigate Safety, Tolerability and Pharmacokinetics of LAE102 in Postmenopausal Women
A Phase 1 study testing LAE102 SC and LAE102 IV in people with Postmenopausal and Healthy Adult Female Participants, run by Laekna Limited at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of LAE102 in healthy postmenopausal women Read more about this study
- Who is it for?
- Ages 45 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal, Healthy Adult Female Participants
- What is being tested?
- LAE102 SC and LAE102 IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2025to 23 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fortrea Clinical Trials
Daytona Beach, Florida, 32117
About this study
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
The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of LAE102 in healthy postmenopausal women
Read the detailed description
This is a placebo-controlled single ascending dose by subcutaneous (SC) and Intravenous (IV) administration in healthy postmenopausal women to assess the safety and tolerability of LAE102. At least 32 healthy female participants will be enrolled in 4 cohorts with each cohort including 8 participants randomized 6:2 LAE102:Placebo.
- Conditions
- Postmenopausal, Healthy Adult Female Participants
- Being tested
- LAE102 SC, Placebo SC, LAE102 IV, Placebo IV
- Keywords
- Postmenopausal Women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAE102 SCDrug
Also called LAE102
A single dose of LAE102 will be administered subcutaneously
Placebo SCDrug
Also called Placebo
A single dose of placebo administered subcutaneously
LAE102 IVDrug
Also called LAE102
A single dose of LAE102 administered intravenously
Placebo IVDrug
Also called Placebo
A single dose of placebo administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| LAE102 SC | Experimental | Participants will receive a single dose by SC administration (3 dose levels) Receives: Drug: LAE102 SC |
| Placebo SC | Placebo comparator | Participants will receive a single dose by SC administration Receives: Drug: Placebo SC |
| LAE102 IV | Experimental | Participants will receive a single IV dose (1 dose level) Receives: Drug: LAE102 IV |
| Placebo IV | Placebo comparator | Participants will receive a single IV dose Receives: Drug: Placebo IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
- PK: Cmax of LAE102
Measured: 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
- PK: AUC of LAE102
Measured: 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
- PK: Tmax of LAE102
Measured: Predose up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start22 Apr 2025
- Primary completion23 Oct 2025
- Study completion23 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostmenopausalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laekna Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Dr. Hugh Coleman, MD, Principal investigator, Fortrea Clinical Research Unit Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908707
- Sponsor's protocol ID
- LAE102INT1003
- Acronym
- LAE102
- Status last verified
- Nov 2025
- First submitted
- 27 Mar 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06908707
- Acronym / sponsor ID
- LAE102 / LAE102INT1003
- Conditions
- Postmenopausal, Healthy Adult Female Participants
- Keywords
- Postmenopausal Women
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Laekna LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 23 Oct 2025 (actual)
- Study completion
- 23 Oct 2025 (actual)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of LAE102 in healthy postmenopausal women
Detailed description
This is a placebo-controlled single ascending dose by subcutaneous (SC) and Intravenous (IV) administration in healthy postmenopausal women to assess the safety and tolerability of LAE102. At least 32 healthy female participants will be enrolled in 4 cohorts with each cohort including 8 participants randomized 6:2 LAE102:Placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LAE102 SC | Experimental | Drug: LAE102 SCParticipants will receive a single dose by SC administration (3 dose levels) |
| Placebo SC | Placebo comparator | Drug: Placebo SCParticipants will receive a single dose by SC administration |
| LAE102 IV | Experimental | Drug: LAE102 IVParticipants will receive a single IV dose (1 dose level) |
| Placebo IV | Placebo comparator | Drug: Placebo IVParticipants will receive a single IV dose |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAE102 SCAlso: LAE102A single dose of LAE102 will be administered subcutaneously | Drug | LAE102 SC |
| Placebo SCAlso: PlaceboA single dose of placebo administered subcutaneously | Drug | Placebo SC |
| LAE102 IVAlso: LAE102A single dose of LAE102 administered intravenously | Drug | LAE102 IV |
| Placebo IVAlso: PlaceboA single dose of placebo administered intravenously | Drug | Placebo IV |
Primary outcome
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
Time frame: Baseline up to 8 weeks
Number of participants with SAEs - Evaluation of Safety and Tolerability of LAE102
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
Time frame: Baseline up to 8 weeks
Number of participants with TEAEs - Evaluation of Safety and Tolerability of LAE102
3 secondary outcomes
To evaluate the Maximum Concentration (Cmax) of LAE102 in healthy postmenopausal women following a single IV or SC dose
Time frame: 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
Time frame: 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
Time frame: Predose up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Hugh Coleman, MD principal investigator
Fortrea Clinical Research Unit Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LAE102 SC and LAE102 IV in people with Postmenopausal and Healthy Adult Female Participants, run by Laekna Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline up to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.