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NCT05965414

Safety and Pharmacokinetics of Single Ascending Doses and Multiple Ascending Doses of CS6253 in Healthy Volunteers

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
Artery Therapeutics, Inc.·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Alzheimer's Disease
Drug/Device/Intervention
CS6253 Solution for Injection
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Artery Therapeutics, Inc.
Timeline & enrollment
Phase
Phase 1
Start date
Sep 04, 2023
End date
Sep 30, 2024
Enrollment
64 participants
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
Alzheimer diseaseAlzheimer disease, unspecifiedOther Alzheimer diseaseDementia in Alzheimer diseaseDementia in Alzheimer disease, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05965414
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.