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

NCT05965414 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-05-11

No results posted yet for this study

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.
* Phase 1 Subcutaneous SC Cohort: One cohort of 6 male and 6 female HVs will receive one SC injection of study drug.

Conditions

Interventions

DRUG

CS6253 Solution for Injection

Solution for intra-venous injection, 50mg CS6253 /mL. Single-use vials containing 100 mg CS6253 (2 mL of 50 mg/mL concentration)

DRUG

Placebo

Physiological saline solution for intra-venous injection

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Artery Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Alberto M. Borobia Perez, MD, Ass.Prof · Universidad Autónoma de Madrid, Farmacología y Terapéutica / Facultad de Medicina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-23
Primary Completion
2024-07-31
Completion
2024-07-31
FDA Drug
Yes

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05965414 on ClinicalTrials.gov