MedTrace Logo

To Assess the Safety, Tolerability and Pharmacokinetics of AZD5634 Following Inhaled and Intravenous (IV)Dose Administration

NCT02679729 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2018-11-05

Study results available
· View outcomes & findings →

Summary

This is a Phase 1, first-in-human (FIH) single ascending dose study being conducted to better understand the safety, tolerability and pharmacokinetics of AZD5634 in healthy subjects

Conditions

Interventions

DRUG

AZD5634 for inhalation

Solution, citrate buffer, saline nebulizer solution; strength 0.1 - 5 mg/g; administered by jet nebulizer

DRUG

AZD5634 for infusion

Solution, citrate buffer, saline solution for infusion; strength 0.013 mg/mL

OTHER

Placebo

inactive substance

Sponsors & Collaborators

Principal Investigators

  • Ronald Goldwater, MDCM, M.Sc, CPI · PAREXEL Early Phase Clinical Unit Baltimore

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-02-11
Primary Completion
2016-10-24
Completion
2016-10-24

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT02679729 on ClinicalTrials.gov