Alzheimer's DiseaseEarly Phase 1NCT05965414
Safety and Pharmacokinetics of Single Ascending Doses and Multiple Ascending Doses of CS6253 in Healthy Volunteers
A Early Phase 1 study testing CS6253 Solution for Injection in people with Alzheimer's Disease, run by Artery Therapeutics, Inc. at 1 site in Spain.
Trial 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 repeated with the max safe dose of the previous cohorts in healthy elderly subjects (male and female of non childbearing… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- CS6253 Solution for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- 23 Oct 2023to 31 Jul 2024
- Phase
- Early 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
- 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.
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- 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.
Who cannot join
- 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%.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Pharmacokinetics of Single Ascending Doses and Multiple Ascending Doses of CS6253 in Healthy Volunteers and in APOE4 Carriers
- 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 repeated with the max safe dose of the previous cohorts in healthy elderly subjects (male and female of non childbearing potential, > 50years)
- Phase 1B MAD: Two or more cohorts of 8 male and female HVs will receive multiple (4) IV bolus injections of study drug or placebo every 72 hours.
- Phase 1 Subcutaneous SC Cohort: One cohort of 6 male and 6 female HVs will receive one SC injection of study drug.
Read the 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 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.
- Conditions
- Alzheimer's Disease
- Being tested
- CS6253 Solution for Injection, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS6253 Solution for InjectionDrug
Solution for intra-venous injection, 50mg CS6253 /mL. Single-use vials containing 100 mg CS6253 (2 mL of 50 mg/mL concentration)
PlaceboDrug
Physiological saline solution for intra-venous injection
| Study group | Role | What they receive |
|---|---|---|
| CS6253 Solution for Injection | Active comparator | 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 Receives: Drug: CS6253 Solution for Injection |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of CS6253
All treatment emerging Adverse Events (TAEs) will be recorded until the SAD: Day 4 and MAD: Day 13
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start23 Oct 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SAD: 5 cohorts 8 of healthy volunteers each will receive single ascending doses of either study drug or placebo (6 active:2 placebo). MAD: 2 or more cohorts 8 of healthy male and female volunteers each will receive single ascending doses of either study drug or placebo (6 active:2 placebo). The subjects will be stratified on their APOE4 status. Each cohort needs to have at least 4 APOE4 carriers.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artery Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Alberto M. Borobia Perez, MD, Ass.Prof, Principal investigator, Universidad Autónoma de Madrid, Farmacología y Terapéutica / Facultad de Medicina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965414
- Sponsor's protocol ID
- ATI-CS-001
- Other IDs
- 1R44AG076299
- Status last verified
- May 2025
- First submitted
- 26 Jan 2023
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared
Publications
Yassine HN, Hugo C, O'Donovan B, Stephens IO, Johnson LA, Cole G, Tcw J, Johansson J, Kisler K, Chiba-Falek O. APOE-Targeted Therapeutics for Alzheimer's Disease. J Neurosci. 2025 Nov 12;45(46):e1388252025. doi: 10.1523/JNEUROSCI.1388-25.2025.
PubMed 41224653
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Pharmacokinetics of Single Ascending Doses and Multiple Ascending Doses of CS6253 in Healthy Volunteers and in APOE4 Carriers
- ClinicalTrials.gov ID
- NCT05965414
- Acronym / sponsor ID
- ATI-CS-001
- Conditions
- Alzheimer's Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Artery Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 28 Jul 2023 (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.
- 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 repeated with the max safe dose of the previous cohorts in healthy elderly subjects (male and female of non childbearing potential, > 50years)
- Phase 1B MAD: Two or more cohorts of 8 male and female HVs will receive multiple (4) IV bolus injections of study drug or placebo every 72 hours.
- Phase 1 Subcutaneous SC Cohort: One cohort of 6 male and 6 female HVs will receive one SC injection of study drug.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- SAD: 5 cohorts 8 of healthy volunteers each will receive single ascending doses of either study drug or placebo (6 active:2 placebo). MAD: 2 or more cohorts 8 of healthy male and female volunteers each will receive single ascending doses of either study drug or placebo (6 active:2 placebo). The subjects will be stratified on their APOE4 status. Each cohort needs to have at least 4 APOE4 carriers.
| Arm | Type | Receives |
|---|---|---|
| CS6253 Solution for Injection | Active comparator | Drug: CS6253 Solution for InjectionSAD: 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 |
| Placebo | Placebo comparator | Drug: PlaceboSAD and MAD: Placebo control will be provided from vials containing physiological saline for injection in an equal amount as necessary for the active arm. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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).
- 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.
Key exclusion criteria (13 listed)
- 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%.
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 |
|---|---|---|
| CS6253 Solution for InjectionSolution for intra-venous injection, 50mg CS6253 /mL. Single-use vials containing 100 mg CS6253 (2 mL of 50 mg/mL concentration) | Drug | CS6253 Solution for Injection |
| PlaceboPhysiological saline solution for intra-venous injection | Drug | Placebo |
Primary outcome
Safety and tolerability of CS6253
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)
All treatment emerging Adverse Events (TAEs) will be recorded until the SAD: Day 4 and MAD: Day 13
SAD-Plasma: AUC0-last
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:
Area under the concentration-time curve until the last quantifiable concentration
SAD-Plasma: AUC0-inf
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:
Area under the concentration time curve from time 0 extrapolated to infinity
SAD-Plasma: Cmax
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:
Maximum observed plasma concentration (eg C0)
SAD-Plasma: Kel
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:
Terminal elimination rate constant
SAD-Plasma: t1/2
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:
Terminal elimination half-life
SAD-Plasma: Clearance (CL/F)
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:
Apparent clearance
SAD-Plasma: Vd/F
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:
Apparent volume of distribution
SAD-Cerebrospinal Fluid (CSF): AUC0-last
Time frame: PK samples will be collected by lumbar catheter starting predose, and at 0.5, 2, 8, 12 and 24 hours postdose.
In cohorts 3-5:Area under the concentration-time curve in CSF until the last quantifiable concentration
SAD-CSF: Cmax
Time frame: PK samples will be collected by lumbar catheter starting predose, and at 0.5, 2, 8, 12 and 24 hours postdose.
In cohorts 3-5:Maximum observed CSF concentration (eg C0)concentration
MAD-Plasma: AUC0-last
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.
Area under the concentration-time curve until the last quantifiable concentration
MAD-Plasma: Cmax
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.
Maximum observed plasma concentration (eg C0)
MAD-CSF:AUC0-last
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.
Area under the concentration-time curve until the last quantifiable concentration
MAD-CSF: Cmax
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.
Maximum observed CSF concentration (eg C0)
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 11 May 2025.
- Derived from this study: PubMed 41224653Yassine HN, Hugo C, O'Donovan B, Stephens IO, Johnson LA, Cole G, Tcw J, Johansson J, Kisler K, Chiba-Falek O. APOE-Targeted Therapeutics for Alzheimer's Disease. J Neurosci. 2025 Nov 12;45(46):e1388252025. doi: 10.1523/JNEUROSCI.1388-25.2025.
- Individual participant dataSharing planned: No. No individual participant data will be shared
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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.
Alberto M. Borobia Perez, MD, Ass.Prof principal investigator
Universidad Autónoma de Madrid, Farmacología y Terapéutica / Facultad de Medicina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CS6253 Solution for Injection in people with Alzheimer's Disease, run by Artery Therapeutics, Inc. at 1 site in Spain.
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 13 inclusion and 13 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 11 May 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 Spain. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Safety and tolerability of CS6253 (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)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05965414, which also lists 1 linked publication.
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 11 May 2025.