A Phase 1, Open-Label, Single Ascending Dose (SAD) Study of SM04646 Inhalation Solution in Healthy Subjects

Phase 1

Completed

• Conditions: Idiopathic pulmonary fibrosis (IPF); Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12615001349538
• Lead Sponsor: Samumed Pacific Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-14
• Study Completion: 2016-07-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

In good general health;
Able to comprehend and willing to sign an informed consent form;
Able to tolerate and complete placebo (vehicle) inhalation for 10 minutes without experiencing a significant cough

Exclusion Criteria

Women who are pregnant or lactating;
Women of childbearing potential who are sexually active and are not willing to use a highly effective method of birth control during the study period;
Males who are sexually active and have a partner who is capable of becoming pregnant, neither of whom have had surgery to become sterilized, that are not using a highly effective method of birth control during the study treatment period until 90 days post study medication administration;
Males unwilling to refrain from sperm donation during the study treatment period until 90 days post study medication administration;
Current smoker, or past history of smoking within 6 months or >10 pack years
Receipt of any of the following medication or treatment prior to the Screening Visit:
a. Prescription medication within 7 days prior to the Screening Visit, except for prescription birth control
b. Previous therapeutic radiation treatment of the lungs, mediastinum, or chest wall
c. Current use of NSAIDs or aspirin (within 24 hours of the Screening Visit)
d. Participation in a clinical research trial that included the receipt of an investigational product or any experimental therapeutic procedure within 1 month or 5 half-lives of the investigational product, whichever is longer, prior to the Screening Visit;
History of any of the following conditions:
a. Idiopathic pulmonary fibrosis
b. Pulmonary embolism or pulmonary hypertension
c. Congenital respiratory conditions (e.g. cystic fibrosis)
d. Chronic obstructive pulmonary disease (COPD)
e. HIV, hepatitis C, or active hepatitis B infection
f. Hepatic cirrhosis
g. Lower respiratory tract infection within 30 days prior to the Screening Visit
h. Coronary artery disease, congestive heart failure, or myocardial infarction
i. Restrictive or obstructive lung disease
j. Hypertension
k. Hypotension
l. Any condition that is dependent on oxygen therapy;
Clinically significant abnormal hematology values or blood chemistry values;
History of clinically significant cardiac arrhythmia

Study & Design

• Study Type: Interventional
• Study Design: Not specified