Status:
COMPLETED
Safety and Pharmacokinetics of Single Ascending Doses and Multiple Ascending Doses of CS6253 in Healthy Volunteers
Lead Sponsor:
Artery Therapeutics, Inc.
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
18-80 years
Phase:
EARLY_PHASE1
Brief Summary
* Phase 1A SAD: Five or more cohorts of 8 healthy volunteers (HVs) will receive a single IV bolus injection of study drug or placebo. The first 4 cohorts will be male only. The last cohort will be rep...
Detailed Description
This is a randomized, double-blind, placebo-controlled study in HV and in APOE4 carriers. Phase 1A Single Ascending Dose (SAD): In 5 or more sequential SAD cohorts of 8 (6 active:2 placebo) HVs a sin...
Eligibility Criteria
Inclusion
- Male HVs at least 18 years old.
- a) Cohort 5 only: Male and female HVs at least 50 years old and if female be of non-childbearing potential, i.e. meet at least one of the following criteria: postsurgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or postmenopausal (amenorrheic for at least 2 years and a serum follicle-stimulating hormone (FSH) \> 30 IU/L).
- b) If subject is male, must be willing to use acceptable contraception from Day 1 until 30 days after the last dose of study drug.
- The subject has a body mass index (BMI) within 18-32 kg/m² (inclusive).
- The subject is in reasonably good health as determined by medical history and physical examination and clinical laboratory tests.
- The subject is willing and able to speak, read, and understand Spanish and give signed informed consent.
- The subject must agree to comply with a lumbar catheterization and collection of blood and CSF samples (SAD Cohorts 3-5 only and MAD cohorts).
- The subject is willing and able to comply with all testing and requirements defined in the protocol.
- The subject is willing, deemed compliant, and able to remain at the Clinical Research Unit (CRU) for the duration of the confinement period and return for all outpatient visits.
- Phase 1B MAD
- The eligibility criteria for the Phase 1B MAD study are the same as described for Phase 1A SAD, with the following exceptions:
- At least 50 years old and female need to be of non-childbearing potential
- Known to have at least 1 APOE4 allele (homozygous or heterozygous). Note: this criterion applies to on average for the MAD at least 4 APOE4 subjects per cohort.
Exclusion
- Subjects who meet any of the following criteria will not be enrolled:
- The subject has any clinically significant deviations from normal in physical examination, ECG, or clinical laboratory tests, as determined by the investigator.
- The subject has an increased bleeding risk or is treated with anti-coagulation therapies including but not limited to aspirin, coumarin, warfarin and heparin.
- The subject has had a clinically significant illness within 30 days of check-in, as determined by the investigator.
- The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.
- History of Type 2 diabetes mellitus or hemoglobin A1c (HbA1c) \> 7%.
- Fasting triglycerides \> 400 mg/dL
- Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2 (Cockcroft-Gault formula)
- The subject has changed the frequency or dose of chronic medication within the last 8 weeks.
- The subject has a history of substance abuse or a positive alcohol or urine drug screen at screening or at check-in.
- The subject has a positive serum hepatitis B surface antigen or positive anti-hepatitis C virus test at the Screening Visit.
- Have positive test results for, or evidence of active infection with, human immunodeficiency virus type 1 or 2, or hepatitis B, or C.
- The subject has received an investigational drug within 30 days of Check-in.
Key Trial Info
Start Date :
October 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT05965414
Start Date
October 23 2023
End Date
July 31 2024
Last Update
May 11 2025
Active Locations (1)
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1
La Paz University Hospital
Madrid, Spain, 28046