Safety and Pharmacokinetics of Single Ascending Doses and Multiple Ascending Doses of CS6253 in Healthy Volunteers - Trial NCT05965414
Access comprehensive clinical trial information for NCT05965414 through Pure Global AI's free database. This Phase 1 trial is sponsored by Artery Therapeutics, Inc. and is currently Not yet recruiting. The study focuses on Alzheimer's Disease. Target enrollment is 64 participants.
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Study Focus
Sponsor & Location
Artery Therapeutics, Inc.
Timeline & Enrollment
Phase 1
Sep 04, 2023
Sep 30, 2024
Primary Outcome
Safety and tolerability of CS6253,SAD-Plasma: AUC0-last,SAD-Plasma: AUC0-inf,SAD-Plasma: Cmax,SAD-Plasma: Kel,SAD-Plasma: t1/2,SAD-Plasma: Clearance (CL/F),SAD-Plasma: Vd/F,SAD-Cerebrospinal Fluid (CSF): AUC0-last,SAD-CSF: Cmax,MAD-Plasma: AUC0-last,MAD-Plasma: Cmax,MAD-CSF:AUC0-last,MAD-CSF: Cmax
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 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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05965414
Non-Device Trial