Cystic FibrosisPhase 1NCT06217952
Safety, Tolerability, and Pharmacokinetics of SPL84 in Healthy Volunteers
A Phase 1 study testing SPL84 in people with Cystic Fibrosis, run by SpliSense Ltd. at 1 site in Israel.
Trial summary
This Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of SPL84 single ascending doses (SAD) in healthy volunteers (HV) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- SPL84
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteIsrael
- Study dates
- 5 Feb 2023to 6 Aug 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Placebo-Controlled, Double Blind Single Ascending Dose Study in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of SPL84
This Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of SPL84 single ascending doses (SAD) in healthy volunteers (HV)
- Conditions
- Cystic Fibrosis
- Being tested
- SPL84, Placebo
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPL84Drug
SPL84 solution for nebulization
PlaceboOther
Placebo solution for nebulization
| Study group | Role | What they receive |
|---|---|---|
| SPL84 | Active comparator | Not described Receives: Drug: SPL84 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of SPL84 as evaluated by number of subjects with at least one treatment-related adverse event (AE) or serious adverse event (SAEs)
Incidence, nature, and severity of AEs and SAEs
Measured: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal heart rate
Measured: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal respiratory rate
Measured: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal systolic and diastolic blood pressure
Measured: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal oximetry
Measured: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal temperature
Measured: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal hematology lab test results
Measured: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal biochemistry lab test results
Measured: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal urinalysis lab test results
Measured: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal electrocardiogram (ECG) parameters
using an ECG machine that automatically calculates heart rate and measure PR, QRS, QT, and QTc intervals
Measured: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal physical examination findings
Complete physical examinations include general appearance, head, ears, eyes, nose, throat, dentition, thyroid, chest (heart, lungs), abdomen, skin, neurological, extremities, back, neck, musculoskeletal, and lymph nodes.
Measured: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal Pulmonary function tests results
Pulmonary function tests will be performed according to the ATS/ERS and FEV1, FVC, and FEF25-75 will be measured
Measured: Day 1 through Day 31
Secondary outcomes (6)
Characterization of PK of SPL84: maximum serum concentration (Cmax)
Measured: Predose and 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose, Day 7 and Day 31.
Characterization of PK of SPL84: Time to Cmax (Tmax)
Measured: Predose and 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose, Day 7 and Day 31.
Characterization of PK of SPL84: terminal elimination half-life (t1/2)
Measured: Predose and 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose, Day 7 and Day 31.
Characterization of PK of SPL84: Area under the curve to the final sample (AUC0-t)
Measured: Predose and 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose, Day 7 and Day 31.
Characterization of PK of SPL84: Area under the curve to infinity (AUC0-∞)
Measured: Predose and 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose, Day 7 and Day 31.
Characterization of PK of SPL84: Apparent clearance (CL/F)
Measured: Predose and 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose, Day 7 and Day 31.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start5 Feb 2023
- Primary completion6 Aug 2023
- Study completion6 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- SpliSense Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217952
- Sponsor's protocol ID
- SPL84-CL-001-P
- Status last verified
- Jan 2024
- First submitted
- 7 Feb 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-Controlled, Double Blind Single Ascending Dose Study in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of SPL84
- ClinicalTrials.gov ID
- NCT06217952
- Acronym / sponsor ID
- SPL84-CL-001-P
- Conditions
- Cystic Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- SpliSense Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Feb 2023 (actual)
- Primary completion
- 6 Aug 2023 (actual)
- Study completion
- 6 Aug 2023 (actual)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of SPL84 single ascending doses (SAD) in healthy volunteers (HV)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPL84 | Active comparator | Drug: SPL84 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPL84SPL84 solution for nebulization | Drug | SPL84 |
| PlaceboPlacebo solution for nebulization | Other | Placebo |
Primary outcome
Safety and Tolerability of SPL84 as evaluated by number of subjects with at least one treatment-related adverse event (AE) or serious adverse event (SAEs)
Time frame: Day 1 through Day 31
Incidence, nature, and severity of AEs and SAEs
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal heart rate
Time frame: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal respiratory rate
Time frame: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal systolic and diastolic blood pressure
Time frame: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal oximetry
Time frame: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal temperature
Time frame: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal hematology lab test results
Time frame: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal biochemistry lab test results
Time frame: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal urinalysis lab test results
Time frame: Day 1 through Day 31
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal electrocardiogram (ECG) parameters
Time frame: Day 1 through Day 31
using an ECG machine that automatically calculates heart rate and measure PR, QRS, QT, and QTc intervals
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal physical examination findings
Time frame: Day 1 through Day 31
Complete physical examinations include general appearance, head, ears, eyes, nose, throat, dentition, thyroid, chest (heart, lungs), abdomen, skin, neurological, extremities, back, neck, musculoskeletal, and lymph nodes.
Safety and Tolerability of SPL84 as assessed by number of participants with abnormal Pulmonary function tests results
Time frame: Day 1 through Day 31
Pulmonary function tests will be performed according to the ATS/ERS and FEV1, FVC, and FEF25-75 will be measured
6 secondary outcomes
Characterization of PK of SPL84: maximum serum concentration (Cmax)
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose, Day 7 and Day 31.
Characterization of PK of SPL84: Time to Cmax (Tmax)
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose, Day 7 and Day 31.
Characterization of PK of SPL84: terminal elimination half-life (t1/2)
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose, Day 7 and Day 31.
Characterization of PK of SPL84: Area under the curve to the final sample (AUC0-t)
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose, Day 7 and Day 31.
Characterization of PK of SPL84: Area under the curve to infinity (AUC0-∞)
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose, Day 7 and Day 31.
Characterization of PK of SPL84: Apparent clearance (CL/F)
Time frame: Predose and 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours postdose, Day 7 and Day 31.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SPL84 in people with Cystic Fibrosis, run by SpliSense Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of SPL84 as evaluated by number of subjects with at least one treatment-related adverse event (AE) or serious adverse event (SAEs) (time frame: Day 1 through Day 31). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.