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Assessment of Safety, Tolerability, Immunogenicity, and Pharmacokinetics of AZD3427

NCT04630067 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2022-10-20

No results posted yet for this study

Summary

This first-time-in-human (FTIH) study will be conducted to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of single doses of AZD3427 in healthy volunteers and multiple doses of AZD3427 in patients with heart failure (HF).

Conditions

Interventions

DRUG

AZD3427

Participants will receive SC or IV dose of AZD3427 as per the arm they are randomized.

DRUG

Placebo

Participants will receive SC or IV dose of placebo matched to AZD3427 as per the arm they are randomized.

Sponsors & Collaborators

Principal Investigators

  • Ronald Goldwater, MD · Parexel Early Phase Clinical Unit (Baltimore), Harbor Hospital, 3001 S. Hanover St., Baltimore, MD 21225, United States of America (USA)

  • David Lanfear, MD · Henry Ford Hospital, USA, MI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-11-17
Primary Completion
2022-09-14
Completion
2022-09-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT04630067 on ClinicalTrials.gov