Study to Investigate the Safety Profile of AZD4721 After Single Doses at Different Dose Levels

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Safety,Plasma AUC and Cmax, Plasma AUC 0-t, t1/2λz, and Tmax

Treatments: Drug: AZD4721 Suspension; Drug: AZD4721 Solution; Drug: AZD4721 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01889160

D5200C00001

Details and patient eligibility

About

Study to investigate the safety profile of AZD4721 after single doses at different dose levels

Full description

A study to investigate safety and tolerability of single ascending doses of AZD4721 given to healthy volunteers. Including a bioequivalence part to compare a solution of AZD4721 with a suspension.

Enrollment: 44 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male and/or female Caucasian (neither Black/African American nor Japanese) volunteers aged 18-50 years. ("Healthy" is as determined by medical history and physical examination, clinical laboratory parameters, and ECG )
2. Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of nonchildbearing potential
3. Volunteers should have a BMI between 18 and 30 kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg (inclusive).

Exclusion criteria

1. History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate
2. Current smokers or those who have smoked or used nicotine products within the previous 3 months

2.Clinically significant lower respiratory tract infection not resolved within 4 weeks prior to Visit 1, as determined by the Investigator

4. Other latent or chronic infections (eg, recurrent sinusitis, genital or ocular herpes, urinary tract infection) or at risk of infection (surgery, trauma, or significant infection) in previous 90 days, or history of skin abscesses within the previous

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

44 participants in 4 patient groups, including a placebo group

Part A Active

Experimental group

Description:

AZD4721 Solution

Treatment:

Drug: AZD4721 Solution

Part A Placebo

Placebo Comparator group

Description:

Placebo for AZD4721

Treatment:

Drug: AZD4721 Placebo

Part B solution

Experimental group

Description:

AZD4721 Solution

Treatment:

Drug: AZD4721 Solution

Part B Suspension

Active Comparator group

Description:

AZD4721 Suspension

Treatment:

Drug: AZD4721 Suspension