Status:
COMPLETED
Safety, Tolerability, and Pharmacokinetics of SPL84 in Healthy Volunteers
Lead Sponsor:
SpliSense Ltd.
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of SPL84 single ascending doses (SAD) in healthy volunteers (HV)
Eligibility Criteria
Inclusion
- Key
- Male adults 18 to 50 years old
- Considered healthy based on medical history, physical examination, 12-lead ECG and clinical laboratory results
- Body Mass Index (BMI) 19.0-30.0 kg/m2
- Subjects who have no difficulties in receiving drugs by inhalation
- Key
Exclusion
- A major surgical procedure or significant traumatic injury within 28 days prior to study intervention administration
- Recent diagnosis of lung disease (\< 12 weeks from planned enrollment)
- Any acute illness (e.g. acute infection) within 48 hours prior to the study intervention administration, which is considered of clinical significance by the Investigator.
- Chronic respiratory disease including but not limited to obstructive airway disease such as asthma or chronic obstructive pulmonary disease (COPD); restrictive disease such as idiopathic pulmonary fibrosis (IPF); or pulmonary vascular disease such as pulmonary arterial hypertension (PAH).
- History of adverse reactions during aerosol delivery of any medicinal product.
- Total body weight ≤50 kg at screening.
- Abnormal forced expiratory volume at one second (FEV1) at screening.
- Oxygen saturation ≤95% at screening.
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), alkaline phosphatase (ALP) and bilirubin (total and direct) above upper limit of normal (ULN) at screening and clinically significant
- Supine systolic blood pressure \<90 or \>140 mmHg, supine diastolic blood pressure \<50 or \>90 mmHg, heart rate \<45 or \>100 beats per minute (bpm), or elevated body temperature (\>38ºC) at screening
- Clinically significant ECG abnormalities at screening
- Positive for SARS-CoV-19 at screening or Day -1 (baseline).
- Positive serology tests for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody at screening.
- Positive urine drug, tobacco, and breath alcohol test result at screening or Day -1 (baseline).
- Use of any prescription or over-the-counter (OTC) medications, including vitamins and herbal or dietary supplements within 14 days prior to dosing.
- Subjects who have received any vaccines within 4 weeks prior to study intervention administration.
- History or current drug/alcohol abuse (excluding use of medicinal cannabis for pain management).
- History of smoking or vaping within 180 days (6 months) of screening
Key Trial Info
Start Date :
February 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06217952
Start Date
February 5 2023
End Date
August 6 2023
Last Update
January 23 2024
Active Locations (1)
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1
Hadassah Ein Kerem Hospital Clinical Research Center
Jerusalem, Israel