An Early Phase 1 interventional study of CS6253 Solution for Injection and Placebo in Alzheimer's Disease, sponsored by Artery Therapeutics, Inc.. Completed at 1 site in Spain. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-11.
Sponsored by Artery Therapeutics, Inc. · Early Phase 1, Interventional, and Treatment
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 single IV bolus injection (CS6253 1, 2.4, 6, and 10 mg/kg or placebo) will be administered and PK, safety, and biomarkers will be assessed. The first 4 cohorts will include males only. In the fifth cohort 8 (6 active:2 placebo) subjects, male and female of non-childbearing potential and at least 50 years old, will be administered CS6253 at equal to or lower doses than the maximum safe SAD dose in HV.
CSF will not be collected in the first 2 SAD cohorts. In the following cohorts, CSF will be collected before dosing and over 24 hours after dosing. Additional cohorts may be added as needed and deemed safe and appropriate by the Data Safety Monitoring Board (DSMB).
Phase 1B Multiple Ascending Dose (MAD): In 2 or more sequential MAD cohorts of 8 (6 active:2 placebo) male and female HVs at least 50 years old on average ≥ 3/sex/cohort; ≥ 4 APOE4 carriers/cohort, will be administered multiple IV bolus injections. Cohort 1 will be administered CS6253 at 75% of the maximum safe SAD dose in subjects at least 50 years old or placebo, and if no Treatment Emerging Adverse Events (TEAEs), in Cohort 2 at 100% of the maximum safe SAD dose or placebo will be administered every 72 hours x 4 doses and PK, safety, and biomarkers will be assessed. Plasma PK will be assessed after first and fourth dose in all cohorts. CSF will be collected before dosing and over 24 hours in conjunction with the fourth dose. Cohorts of 8 subjects (6 active:2 placebo) may be added at doses equal to or lower than the maximum safe MAD dose to further explore CS6253 brain exposure and Pharmacodynamics (PD) dependency on APOE4 isoform and sex.
Phase 1 Subcutaneous SC Cohort: One cohort of 6 (>=4) male and 6 (>=4) female HVs will receive one SC injection of study drug. From these 12 subjects (>=4) female and (>=4) male subjects need to be an APOE4 carrier.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 66 is close to the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
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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.
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:
Exclusion Criteria:
Subjects who meet any of the following criteria will not be enrolled:
SAD: Single ascending doses: CS6253 Solution for Injection dosing, 50 mg/mL, will be weight based and provided from single use 2 mL vials containing approximately 100 mg CS6253 in phosphate buffered saline (PBS) solution MAD: Multiple ascending doses (4x every 72 hours): CS6253 Solution for Injection dosing, 50 mg/mL, will be weight based and provided from single use 2 mL vials containing approximately 100 mg CS6253 in phosphate buffered saline (PBS) solution
Drug: CS6253 Solution for Injection
SAD and MAD: Placebo control will be provided from vials containing physiological saline for injection in an equal amount as necessary for the active arm.
Drug: Placebo
Solution for intra-venous injection, 50mg CS6253 /mL. Single-use vials containing 100 mg CS6253 (2 mL of 50 mg/mL concentration)
Physiological saline solution for intra-venous injection
Safety and tolerability of CS6253
All treatment emerging Adverse Events (TAEs) will be recorded until the SAD: Day 4 and MAD: Day 13
Time frame: SAD: After dosing and until 72 hours after dosing; MAD: After dosing until day 13 (72 hours after the last dosing on day 10)
SAD-Plasma: AUC0-last
Area under the concentration-time curve until the last quantifiable concentration
Time frame: Pharmacokinetics (PK) samples will be collected at predose and at 0.16, 0.5, 1, 2, 4, 8, 12, 24, 48, and 72 hours postdose; MAD:
SAD-Plasma: AUC0-inf
Area under the concentration time curve from time 0 extrapolated to infinity
Time frame: PK samples will be collected at predose and at 0.16, 0.5, 1, 2, 4, 8, 12, 24, 48, and 72 hours postdose; MAD:
SAD-Plasma: Cmax
Maximum observed plasma concentration (eg C0)
Time frame: PK samples will be collected at predose and at 0.16, 0.5, 1, 2, 4, 8, 12, 24, 48, and 72 hours postdose; MAD:
SAD-Plasma: Kel
Terminal elimination rate constant
Time frame: PK samples will be collected at predose and at 0.16, 0.5, 1, 2, 4, 8, 12, 24, 48, and 72 hours postdose; MAD:
SAD-Plasma: t1/2
Terminal elimination half-life
Time frame: PK samples will be collected at predose and at 0.16, 0.5, 1, 2, 4, 8, 12, 24, 48, and 72 hours postdose; MAD:
SAD-Plasma: Clearance (CL/F)
Apparent clearance
Time frame: PK samples will be collected at predose and at 0.16, 0.5, 1, 2, 4, 8, 12, 24, 48, and 72 hours postdose; MAD:
SAD-Plasma: Vd/F
Apparent volume of distribution
Time frame: PK samples will be collected at predose and at 0.16, 0.5, 1, 2, 4, 8, 12, 24, 48, and 72 hours postdose; MAD:
SAD-Cerebrospinal Fluid (CSF): AUC0-last
In cohorts 3-5:Area under the concentration-time curve in CSF until the last quantifiable concentration
Time frame: PK samples will be collected by lumbar catheter starting predose, and at 0.5, 2, 8, 12 and 24 hours postdose.
SAD-CSF: Cmax
In cohorts 3-5:Maximum observed CSF concentration (eg C0)concentration
Time frame: PK samples will be collected by lumbar catheter starting predose, and at 0.5, 2, 8, 12 and 24 hours postdose.
MAD-Plasma: AUC0-last
Area under the concentration-time curve until the last quantifiable concentration
Time frame: PK samples will be collected after the first and fourth doses (Day 1 and Day 10) at predose and at 0.16, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72 hours postdose.
MAD-Plasma: Cmax
Maximum observed plasma concentration (eg C0)
Time frame: PK samples will be collected after the first and fourth doses (Day 1 and Day 10) at predose and at 0.16, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72 hours postdose.
MAD-CSF:AUC0-last
Area under the concentration-time curve until the last quantifiable concentration
Time frame: CSF collection by lumbar puncture (LP) will be performed before the first dose. At the fourth dose, on Day 10, serial CSF samples will be collected by lumbar catheter starting predose, and at 0.5, 2, 8, 12 and 24 hours postdose.
MAD-CSF: Cmax
Maximum observed CSF concentration (eg C0)
Time frame: CSF collection by lumbar puncture (LP) will be performed before the first dose. At the fourth dose, on Day 10, serial CSF samples will be collected by lumbar catheter starting predose, and at 0.5, 2, 8, 12 and 24 hours postdose.
Plan to share: No — No individual participant data will be shared
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