Study of a Single Dose of PRS-060 Administered by Oral Inhalation or IV Infusion in Healthy Subjects

NCT ID: NCT03384290

Last Updated: 2020-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-08
• Study Completion Date: 2018-10-11

Brief Summary

A Dose Escalating Study of PRS-060 Administered by Oral Inhalation or IV Infusion in Healthy Subjects

Detailed Description

PRS-060 is a new drug being developed for treatment of asthma. The main purpose of this study is to investigate the safety, tolerability and pharmacokinetics of single ascending doses of PRS-060 in healthy subjects

Conditions

Healthy Subjects

Keywords

Asthma; Anticalin; PRS-060; Healthy Volunteers; Pieris; IL-4 receptor alpha; IL-13; IL-4

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

PRS-060 Matching Placebo

PRS-060

Group Type: EXPERIMENTAL

PRS-060

Intervention Type: DRUG

Drug

Interventions

PRS-060

Drug

Intervention Type: DRUG

Placebo

PRS-060 Matching Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male and female of non-childbearing potential (post-menopausal or surgically sterilized) subjects of 18 to 55 years of age
• Body mass index (BMI) of 18-35
• Subjects who are non-smokers or ex-smokers who have not smoked in the last 6 months (determined by urine cotinine < 500 ng/ml, at screening visit).

Exclusion Criteria

• History or clinical manifestations of any clinically significant medical disorder that, in the opinion of the investigator, may put the subject at risk because of participation in the study, influence the results of the study or affect the subject's ability to participate in the study.
• A history of drug or alcohol abuse.
• History of, or known significant infection including hepatitis A, B, or C, Human immunodeficiency Virus (HIV), tuberculosis (i.e., positive result for Interferon (INF)-y release assay (IGRA), QuantiFERON TB-Gold), that may put the subject at risk during participation in the study.
• Any clinically significant illness, infection, medical/surgical procedure, or trauma within 4 weeks of day 1 or planned inpatient surgery or hospitalization during the study period.
• Subjects with any history of malignancy or neoplastic disease.
• Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, as judged by the principal investigator.
• Subjects who have received live or attenuated vaccine in the 4 weeks prior to day 1 subjects with a disease history suggesting abnormal immune function
• Inability to communicate well with the Investigator (i.e. language problem, poor mental development or impaired cerebral function)
• Participation in any clinical study for a New Chemical Entity within the previous 16 weeks or a marketed drug clinical study within the previous 12 weeks or within 5 half- lives, whichever is the longer, before the first dose of study drug.
• Donation of 450 ml or more blood within the previous 12 weeks
• Women who are pregnant
• Males who are sexually active with a female partner of childbearing potential and who have not had a vasectomy and who do not agree to double methods of contraception with at least one barrier from day 1 for 90 days.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pieris Australia Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason Lickliter, MBBS PhD

Role: PRINCIPAL_INVESTIGATOR

Nucleus Network

Locations

Nucleus Network Limited

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

PRS-060-PCS_06_17

Identifier Type: -

Identifier Source: org_study_id