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Single-Dose and Multiple-Dose, Dose-Escalation Study with LY2599666 to Evaluate the Safety, Pharmacokinetics, and Tolerability in Healthy Subjects and Patients with Mild Cognitive Impairment Due to Alzheimer's Disease and Mild to Moderate Alzheimer's Disease

Single-Dose and Multiple-Dose, Dose-Escalation Study with LY2599666 to Evaluate the Safety, Pharmacokinetics, and Tolerability in Healthy Subjects and Patients with Mild Cognitive Impairment Due to Alzheimer's Disease and Mild to Moderate Alzheimer's Disease

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080223114
Enrollment
Unknown
Registered
2016-02-24
Start date
2016-02-24
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy/Mild Cognitive Impairment due to Alzheimer's Disease/Mild-to-moderate Alzheimer's Disease

Interventions

investigational material(s) Generic name etc : LY2599666 (Part A) INN of investigational material : Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administr

Sponsors

Eli Lilly Japan K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Healthy Participants Part A: -Overtly healthy males or females as determined by medical history and physical examination -Have a body mass index (BMI) between 18.0 and 32.0 kilograms per meter squared (kg/m2), inclusive Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD) [Part B and C]: -Participants are at least 50 years old at screening -Present with Mild Cognitive Impairment (MCI) due to Alzheimer's Disease (AD) or mild-to-moderate AD -Have a caregiver/study informant who provides a separate written informed consent to participate -Have adequate vision and hearing for neuropsychological testing in the opinion of the investigator -Positive florbetapir scan

Exclusion criteria

Exclusion criteria: All Participants -Are currently enrolled in a clinical trial involving an investigational product or off-label use of a drug or device or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study -Have known allergies to LY2599666, solanezumab, or any related compounds or components of the formulations, or have a history of significant atopy -Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study -Have an abnormal blood pressure as determined by the investigator -Have significant allergies to humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisone -Require treatment with other monoclonal antibodies Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD) [Part B and C] -Have medical or surgical conditions in which lumbar puncture and or/catheter insertion is contraindicated -Have any contraindication for magnetic resonance imaging (MRI) studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD) [Part C] -Have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate-specific antigen post treatment

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026