Non-Cystic Fibrosis BronchiectasisPhase 1CHF6333 FIHNCT03056326
A Study to Investigate Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of CHF6333 in Healthy Subjects
A Phase 1 study testing CHF6333 (Part 1 - SAD) and CHF6333 (Part 2 - MAD) in people with Non-Cystic Fibrosis Bronchiectasis and Cystic Fibrosis, run by Chiesi Farmaceutici S.p.A. at 1 site in Belgium.
Trial summary
Human Neutrophil Elastase (HNE) plays a pivotal role in innate immunity and in neutrophilic lung inflammation that characterized many diseases. CHF 6333 is a potent and 24h-durable inhibitor of HNE, developed as Dry Powder Inhaler (DPI) formulation. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Non-Cystic Fibrosis Bronchiectasis, Cystic Fibrosis
- What is being tested?
- CHF6333 (Part 1 - SAD) and CHF6333 (Part 2 - MAD)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2016to Jul 2017
- 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 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subjects aged 18-55 years
- BMI between 18-30 kg/m2
- Non smokers
- Lung function above 80% of predicted normal value
- Healthy subjects based on medical evaluation including medical history, physical examination, laboratory tests and cardiac testing
Who cannot join
- Any clinically relevant abnormalities and/or uncontrolled diseases
- Abnormal laboratory values
- Recent respiratory tract infection
- Hypersensitivity to the drug or excipients
- Positive serology results
- Positive cotinine, alcohol, drug of abuse tests
- Unsuitable veins for repeated venepuncture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF 6333 After Single and Repeated Ascending Doses in Healthy Male Subjects
Human Neutrophil Elastase (HNE) plays a pivotal role in innate immunity and in neutrophilic lung inflammation that characterized many diseases. CHF 6333 is a potent and 24h-durable inhibitor of HNE, developed as Dry Powder Inhaler (DPI) formulation. This study is designed to investigate the tolerability, safety and pharmacokinetics of inhaled CHF6333 DPI in healthy male subjects.
The study will comprise two parts:
Read more
Part 1 will consist of two alternated cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of Single Ascending Dose (SAD) of CHF6333.
Part 2 will consist of four sequential cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of Multiple Ascending Dose (MAD) of CHF6333
- Being tested
- CHF6333 (Part 1 - SAD), Placebo (Part 1 - SAD), CHF6333 (Part 2 - MAD), Placebo (Part 2 - MAD)
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHF6333 (Part 1 - SAD)Drug
Single doses of CHF6333 at each period
Placebo (Part 1 - SAD)Drug
Single doses of placebo matching CHF6333 at each period
CHF6333 (Part 2 - MAD)Drug
once daily multiple doses of CHF6333 for 14 days
Placebo (Part 2 - MAD)Drug
once daily multiple doses of placebo matching CHF6333 for 14 days
| Study group | Role | What they receive |
|---|---|---|
| CHF6333 Active | Experimental | Not described Receives: Drug: CHF6333 (Part 1 - SAD); Drug: CHF6333 (Part 2 - MAD) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo (Part 1 - SAD); Drug: Placebo (Part 2 - MAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Treatment-related Adverse events
Measured: Part 1 from Day 1 to 5, Part 2 from Day 1 to 15
Change in Vital signs
Blood pressure
Measured: Part 1 from Day 1 to 5, Part 2 from Day 1 to 15
Heart Rate
Change in Heart Rate (from ECG)
Measured: Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15
QTcF interval
Change in QTcF interval (from ECG)
Measured: Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15
PR interval
Change in PR interval (from ECG)
Measured: Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15
QRS interval
Change in QRS interval (from ECG)
Measured: Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15
Holter recording abnormalities
24h-holter ECG recording
Measured: Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15
FEV1
Change in FEV1 (Forced exhalation volume in the first second)
Measured: Part 1 Day 1-2, Part 2 Day 1-14-15
Clinical chemistry and haematology
change in Clinical chemistry and haematology parameters
Measured: Part 1 Day 1-5, Part 2 Day 1-15
Urinalysis
Change in urinalysis parameters
Measured: Part 1 Day 1-5, Part 2 Day 1-15
Secondary outcomes (9)
Area under the plasma concentration
Measured: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15
Peak plasma concentration (Cmax)
maximum plasma concentration of CHF6333
Measured: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15
Time to reach the maximum plasma concentration (tmax)
Measured: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15
Elimination half-life (t1/2)
Measured: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15
Clearance (CL/F)
Absolute plasma clearance
Measured: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15
Volume of distribution (Vz/F)
plasma volume of distribution
Measured: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15
Urinary excretion (Ae)
Amount of CHF6333 excreted in urine
Measured: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15
fraction excreted (fe)
Percentage of drug excreted in urine
Measured: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15
Renal clearance (CLr)
Measured: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study startNov 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Cystic Fibrosis BronchiectasisStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- 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
- Model description
- Part 1: alternating cross-over design Part 2: parallel design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frédéric Vanhoutte, Principal investigator, SGS Life Sciences, a division of SGS Belgium NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056326
- Sponsor's protocol ID
- CCD-06333AA1-01
- Other IDs
- 2015-005552-94, 2015
- Acronym
- CHF6333 FIH
- Status last verified
- Nov 2017
- First submitted
- 3 Feb 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF 6333 After Single and Repeated Ascending Doses in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03056326
- Acronym / sponsor ID
- CHF6333 FIH / CCD-06333AA1-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 17 Feb 2017 (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.
Human Neutrophil Elastase (HNE) plays a pivotal role in innate immunity and in neutrophilic lung inflammation that characterized many diseases. CHF 6333 is a potent and 24h-durable inhibitor of HNE, developed as Dry Powder Inhaler (DPI) formulation. This study is designed to investigate the tolerability, safety and pharmacokinetics of inhaled CHF6333 DPI in healthy male subjects.
The study will comprise two parts:
Part 1 will consist of two alternated cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of Single Ascending Dose (SAD) of CHF6333.
Part 2 will consist of four sequential cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of Multiple Ascending Dose (MAD) of CHF6333
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Part 1: alternating cross-over design Part 2: parallel design
| Arm | Type | Receives |
|---|---|---|
| CHF6333 Active | Experimental | Drug: CHF6333 (Part 1 - SAD), Drug: CHF6333 (Part 2 - MAD) |
| Placebo | Placebo comparator | Drug: Placebo (Part 1 - SAD), Drug: Placebo (Part 2 - MAD) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male subjects aged 18-55 years
- BMI between 18-30 kg/m2
- Non smokers
- Lung function above 80% of predicted normal value
- Healthy subjects based on medical evaluation including medical history, physical examination, laboratory tests and cardiac testing
Key exclusion criteria (7 listed)
- Any clinically relevant abnormalities and/or uncontrolled diseases
- Abnormal laboratory values
- Recent respiratory tract infection
- Hypersensitivity to the drug or excipients
- Positive serology results
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 |
|---|---|---|
| CHF6333 (Part 1 - SAD)Single doses of CHF6333 at each period | Drug | CHF6333 Active |
| Placebo (Part 1 - SAD)Single doses of placebo matching CHF6333 at each period | Drug | Placebo |
| CHF6333 (Part 2 - MAD)once daily multiple doses of CHF6333 for 14 days | Drug | CHF6333 Active |
| Placebo (Part 2 - MAD)once daily multiple doses of placebo matching CHF6333 for 14 days | Drug | Placebo |
Primary outcome
Adverse events
Time frame: Part 1 from Day 1 to 5, Part 2 from Day 1 to 15
Treatment-related Adverse events
Change in Vital signs
Time frame: Part 1 from Day 1 to 5, Part 2 from Day 1 to 15
Blood pressure
Heart Rate
Time frame: Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15
Change in Heart Rate (from ECG)
QTcF interval
Time frame: Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15
Change in QTcF interval (from ECG)
PR interval
Time frame: Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15
Change in PR interval (from ECG)
QRS interval
Time frame: Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15
Change in QRS interval (from ECG)
Holter recording abnormalities
Time frame: Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15
24h-holter ECG recording
FEV1
Time frame: Part 1 Day 1-2, Part 2 Day 1-14-15
Change in FEV1 (Forced exhalation volume in the first second)
Clinical chemistry and haematology
Time frame: Part 1 Day 1-5, Part 2 Day 1-15
change in Clinical chemistry and haematology parameters
Urinalysis
Time frame: Part 1 Day 1-5, Part 2 Day 1-15
Change in urinalysis parameters
9 secondary outcomes
Area under the plasma concentration
Time frame: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15
Peak plasma concentration (Cmax)
Time frame: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15
Time to reach the maximum plasma concentration (tmax)
Time frame: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15
Elimination half-life (t1/2)
Time frame: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15
Clearance (CL/F)
Time frame: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15
Volume of distribution (Vz/F)
Time frame: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15
Urinary excretion (Ae)
Time frame: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15
fraction excreted (fe)
Time frame: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15
Renal clearance (CLr)
Time frame: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15
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 7 Nov 2017.
- Individual participant dataSharing planned: Undecided
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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.
Frédéric Vanhoutte principal investigator
SGS Life Sciences, a division of SGS Belgium NV
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 CHF6333 (Part 1 - SAD) and CHF6333 (Part 2 - MAD) in people with Non-Cystic Fibrosis Bronchiectasis and Cystic Fibrosis, run by Chiesi Farmaceutici S.p.A. at 1 site in Belgium.
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 5 inclusion and 7 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 7 Nov 2017. 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 Belgium. 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?
Adverse events (time frame: Part 1 from Day 1 to 5, Part 2 from Day 1 to 15). The study lists 10 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 7 Nov 2017.