Clinical Study to Assess Safety, PK and PD Parameters of CDR132L

Sponsor
Cardior Pharmaceuticals GmbH
Study ID
NCT04045405
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • CDR132L — DRUG
    i.v. administration

Study Details

This is a Phase I, randomized, double-blind, placebo-controlled study to assess safety, pharmacokinetics and pharmacodynamic parameters of CDR132L in patients with stable heart failure of ischemic origin (NYHA 1-3).

Key Dates

Start date
Jun 21, 2019
Status verified
Jan 2026
Primary completion
Jan 31, 2020
Completion
Jun 26, 2020

Study Design

Enrollment
28 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CDR132L
  • Placebo Comparator: Saline

Primary Outcome Measure

Incidence of treatment-emergent adverse events [safety and tolerability] [ Time Frame: 4 months ]

Related Studies