Safety, Tolerability, and Pharmacokinetics of SPL84 in Healthy Volunteers

SpliSense

Status and phase

Completed

Phase 1

Conditions

Cystic Fibrosis

Treatments

Other: Placebo

Drug: SPL84

Study type

Interventional

Funder types

Industry

Identifiers

NCT06217952

SPL84-CL-001-P

Details and patient eligibility

About

This Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of SPL84 single ascending doses (SAD) in healthy volunteers (HV)

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

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 Criteria:

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