Safety, Tolerability, and Pharmacokinetics of SPL84 in Healthy Volunteers

NCT ID: NCT06217952

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-05
• Study Completion Date: 2023-08-06

Brief Summary

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

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SPL84

Group Type: ACTIVE_COMPARATOR

SPL84

Intervention Type: DRUG

SPL84 solution for nebulization

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo solution for nebulization

Interventions

SPL84

SPL84 solution for nebulization

Intervention Type: DRUG

Placebo

Placebo solution for nebulization

Intervention Type: OTHER

Eligibility Criteria

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

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

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

Sponsors

SpliSense Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hadassah Ein Kerem Hospital Clinical Research Center

Jerusalem, , Israel

Countries

Israel

Other Identifiers

SPL84-CL-001-P

Identifier Type: -

Identifier Source: org_study_id