Healthy VolunteersPhase 1NCT07163182
Evaluation of Safety, Side Effects and How the Drug CHF6467 Administered Via Intranasal Route is Absorbed, Modified and Removed in Healthy Subjects
A Phase 1 study testing CHF6467 Part 1 (SAD) and CHF6467 Part 2 (MAD) in people with Healthy Volunteers, run by Chiesi Farmaceutici S.p.A. at 1 site in Bulgaria.
Trial summary
A clinical trial to investigate the safety and tolerability of single and multiple intranasal (through the nose) dosing with the study drug CHF6467 in 68 healthy adult subjects. The study will investigate also how CHF6467 moves and behaves in the blood and in the fluid around the brain and spinal cord (cerebrospinal… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- CHF6467 Part 1 (SAD) and CHF6467 Part 2 (MAD)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteBulgaria
- Study dates
- 15 Sep 2025to 28 Feb 2027
- Phase
- Phase 1
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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject's written informed consent obtained prior to any study-related procedures;
- Willingness and ability to understand the risks involved and to understand and comply with the study procedures;
- Healthy male and female subjects, aged 18-55 years inclusive at screening;
- Weight ≥ 50 kg and <85 kg and Body Mass Index (BMI) between 18.0 and 30.0 kg/m² inclusive at screening and on Day -1;
- Non-smoker or ex-smoker who smoked less than 5 pack years (Pack years = the number of cigarette packs per day times the number of years) and stopped smoking at least 1 year prior to screening;
- Good physical condition and mental status determined by the Investigator, based on the subject's medical history and general clinical examination at screening and Day -1;
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- Vital signs within normal limits at screening and at Day-1: 60 mmHg ≤ diastolic blood pressure (DBP) ≤ 89 mmHg, 90 mmHg ≤ systolic blood pressure (SBP) ≤ 139 mmHg (three measures performed after at least 5 minutes of resting; the mean value must be within the defined range). Axillary body temperature of 35.5-37.0º Celsius inclusive;
- Bedside 12-lead electrocardiogram (ECG) considered as normal (45 bpm ≤ heart rate [HR] ≤ 100 bpm, 120 ms ≤ PR interval [PR] ≤ 210 ms, QRS interval [QRS] ≤ 120 ms, QT interval [QT] corrected using Fridericia's formula [QTcF] ≤ 450 ms for males and ≤ 470 ms for females) at screening visit and Day -1; the mean value of three measurements must be within the range.
- Males fulfilling one of the following criteria:
- Males with pregnant or non-pregnant women of childbearing potential (WOCBP) partners: they must be willing to use male condom from the signature of the informed consent and until the follow-up visit or
- Non-fertile male subjects (contraception is not required in this case) or
- Males with partner not of childbearing potential (contraception is not required in this case);
- Female subjects fulfilling one of the following criteria:
- Women of non-childbearing potential (WOCBP) defined as physiologically incapable of becoming pregnant (i.e., post-menopausal or permanently sterile). Tubal ligation or partial surgical interventions are not acceptable. If indicated, as per Investigator's request, post-menopausal status may be confirmed by follicle-stimulating hormone (FSH) levels (according to local laboratory ranges);
- WOCBP fulfilling one of the following criteria:
- WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method preferably with low user dependency from the signature of the informed consent and until the follow-up visit; or ii. WOCBP with non-fertile male partners (contraception is not required in this case).
Who cannot join
- The subject has taken non-permitted concomitant medications in the predefined period prior to screening or prior to randomisation or is expected to take non-permitted concomitant medications during the study;
- Participation to investigational study: subjects who have received any investigational drug within the 30 days (60 days for biologics) or a more appropriate time as determined by the Investigator (e.g. approximately 5 half-lives of the investigational drug whatever is longer);
- Significant nasal congestion or signs of nasal damage, bleeding, excoriation or ulceration at physical examination at screening or Day -1;
- History of frequent nosebleeds;
- Any ongoing acute (e.g. non-allergic rhinitis) or chronic (e.g. chronic rhinosinusitis or chronic purulent postnasal drip) condition of the nasal cavity, or clinically significant physical finding (e.g. nasal polyps, nasal structural abnormalities, nasal trauma, severe nasal septal deviation) which, in the opinion of the Investigator, can interfere with the administration or absorption of the study medication. Subjects with recent upper respiratory tract infections will be allowed in the study only if their nasal symptoms have been completely resolved for more than 2 weeks prior to screening;
- Clinically significant abnormal 24-hour Holter at screening;
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- Clinically relevant and uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic or psychiatric disorder that may interfere with successful completion of this protocol, any known malignancies, or any condition that in Investigator's opinion may pose the subject at risk from participating in the study;
- Any clinically relevant abnormal laboratory value at screening or Day -1suggesting an undiagnosed condition that requires further clinical investigation or may impact the safety of the subject or the evaluation of the study results according to the Investigator's judgement; Note: In case of abnormal laboratory values that could indicate a temporary condition, the test can be repeated once before randomisation;
- For females only: pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until termination of the gestation, confirmed by a positive serum human chorionic gonadotropin laboratory test. Serum pregnancy test to be performed at screening and urine pregnancy test to be performed at Day -1.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bulgaria1 site, 1 recruiting
- Recruiting
Bulgaria MC Comac Medical Ltd.
Sofia, 1618
Maya Dabcheva, MD
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of CHF6467 After Single and Repeated Ascending Doses by Intranasal Route in Healthy Adult Subjects
A clinical trial to investigate the safety and tolerability of single and multiple intranasal (through the nose) dosing with the study drug CHF6467 in 68 healthy adult subjects.
The study will investigate also how CHF6467 moves and behaves in the blood and in the fluid around the brain and spinal cord (cerebrospinal fluid) and if the drug CHF6467 causes an immune response by looking for specific molecules, called antibodies that may form against it.
Read more
The study will be divided into two parts - Part 1 (testing single ascending doses of the study drug, SAD, lasting 4 days) and Part 2 (testing repeated or multiple ascending doses of the study drug, MAD, lasting 11 days).
Each part of the study consists of a screening period, when eligible healthy volunteers will be selected, a treatment period, during which the study drug administration will take place and a follow-up period.
- Conditions
- Healthy Volunteers
- Being tested
- CHF6467 Part 1 (SAD), CHF6467 Part 2 (MAD), Placebo
- Keywords
- Single Ascending Dose, Multiple Ascending Dose, Intranasal, Cerebrospinal fluid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHF6467 Part 1 (SAD)Biological
Intranasal administration of single ascending doses of CHF6467 in 4 different cohorts
CHF6467 Part 2 (MAD)Biological
Intranasal administration of multiple ascending doses of CHF6467 in 3 different cohorts
PlaceboDrug
Intranasal administration of matched-placebo of CHF6467 in Part 1 and Part 2
| Study group | Role | What they receive |
|---|---|---|
| Test Treatment | Active comparator | Intranasal (IN) CHF6467 Receives: Biological: CHF6467 Part 1 (SAD); Biological: CHF6467 Part 2 (MAD) |
| Reference Treatment | Placebo comparator | Intranasal (IN) placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs) and Adverse Drug Reactions (ADRs)
Number of events and number and percentage of subjects experiencing treatment-emergent AEs (TEAEs), treatment-emergent ADRs, serious TEAEs, non-serious TEAEs, severe TEAEs, TEAEs leading to discontinuation of study treatment and TEAEs leading to death
Measured: From screening (3 to 21 days prior to Day 1) to the last follow-up visit (29 ±3 days after Day 1 for Part 1; 85 ±3 days after Day 1 for Part 2)
Vital signs: heart rate (HR)
Mean absolute value
Measured: From Day 1 pre-dose to the first follow-up visit (15 ±3 days after Day 1 for Part 1; between 7 and 14 days after Day 10 for Part 2)
Vital signs: body temperature (BT)
Mean absolute value
Measured: From Day 1 pre-dose to the first follow-up visit (15 ±3 days after randomisation for Part 1; between 7 and 14 days after last administration for Part 2)
Vital signs: systolic blood pressure (SBP), diastolic blood pressure (DBP)
- Mean absolute value
- Mean change from baseline
Measured: From Day 1 pre-dose to the first follow-up visit (15 ±3 days after Day 1 for Part 1; between 7 and 14 days after Day 10 for Part 2)
Bedside 12-lead ECG intervals (HR, PR, QRS, QT, QTcF)
Mean absolute value
Measured: From Day 1 pre-dose to the first follow-up visit (15 ±3 days after Day 1 for Part 1; between 7 and 14 days after Day 10 for Part 2)
Bedside 12-lead ECG intervals (HR, PR, QRS, QT, QTcF)
Mean change from baseline
Measured: From Day 1 pre-dose to the first follow-up visit (15 ±3 days after Day 1 for Part 1; between 7 and 14 days after Day 10 for Part 2)
Bedside 12-lead ECG intervals (HR, PR, QRS, QT, QTcF)
Mean difference vs. placebo in change from baseline
Measured: From Day 1 pre-dose to the first follow-up visit (15 ±3 days after Day 1 for Part 1; between 7 and 14 days after Day 10 for Part 2)
Bedside 12-lead ECG intervals (HR, PR, QRS, QT, QTcF)
Number and percentage of subjects with:
- QTcF > 450 ms, > 480 ms and > 500 ms;
- Change from baseline in QTcF > 30 ms and > 60 ms
Measured: From Day 1 pre-dose to the first follow-up visit (15 ±3 days after Day 1 for Part 1; between 7 and 14 days after Day 10 for Part 2)
12-lead ECG parameters extracted from Holter (HR, PR, QRS, QTcF and QT)
Mean absolute value
Measured: From Day 1 pre-dose to 24 hours post-dose (Day 2 in Part 1; Day 11 in Part 2)
12-lead ECG parameters extracted from Holter (HR, PR, QRS, QTcF and QT)
Mean change from baseline
Measured: From Day 1 pre-dose to 24 hours post-dose (Day 2 in Part 1; Day 11 in Part 2)
12-lead ECG parameters extracted from Holter (HR, PR, QRS, QTcF and QT)
Mean difference vs. placebo in change from baseline.
Measured: From Day 1 pre-dose to 24 hours post-dose (Day 2 in Part 1; Day 11 in Part 2)
12-lead ECG parameters extracted from Holter (HR, PR, QRS, QTcF and QT)
The number and percentage of subjects with:
- QTcF > 450 ms, > 480 ms and > 500 ms;
- Change from baseline in QTcF > 30 ms and > 60 ms
Measured: From Day 1 pre-dose to 24 hours post-dose (Day 2 in Part 1; Day 11 in Part 2)
12-lead Holter abnormal findings (total pauses > 2.5 seconds, atrial fibrillation and atrial flutter, ventricular runs, premature atrial contractions (PAC) burden, premature ventricular contractions (PVC) burden, other aberrant morphologies
Measured: From Day 1 pre-dose to 24 hours post-dose (Day 2 in Part 1; Day 11 in Part 2)
Mean 24-hour heart rate (HR0-24h, from 12-lead Holter recording) and mean hourly HR
Measured: From Day 1 pre-dose to 24 hours post-dose
Blood laboratory tests evaluation: chemistry, haematology
Shift table will be presented by treatment at each post-dose time point
Measured: From Day 1 pre-dose to the first follow-up visit (15 ±3 days after Day 1 for Part 1; between 7 and 14 days after Day 10 for Part 2)
Blood laboratory tests evaluation: chemistry, haematology
Mean absolute value will be presented by treatment
Measured: From Day 1 pre-dose to the first follow-up visit (15 ±3 days after Day 1 for Part 1; between 7 and 14 days after Day 10 for Part 2)
Blood laboratory tests evaluation: chemistry, haematology
Mean change from baseline (Day -1) will be presented by treatment at each post-dose time point
Measured: From Day 1 pre-dose to the first follow-up visit (15 ±3 days after Day 1 for Part 1; between 7 and 14 days after Day 10 for Part 2)
Urine laboratory tests evaluation (urine strip): urinalysis
Urinalysis values will be presented in the listings for each subject
Measured: From Day 1 pre-dose to the first follow-up visit (15 ±3 days after Day 1 for Part 1; between 7 and 14 days after Day 10 for Part 2)
Secondary outcomes (19)
CHF6467 AUC0-24h
Area under the concentration-time curve from time 0 to 24 h
Measured: From Day 1 pre-dose to the end of treatment (Day 1 in Part 1; Day 10 in Part 2)
CHF6467 AUC0-t
Area Under the Curve from time 0 to time t
Measured: From Day 1 pre-dose to the end of treatment (Day 1 in Part 1; Day 10 in Part 2)
CHF6467 AUC0-∞
Area Under the Curve from time 0 Extrapolated to Infinity
Measured: From Day 1 pre-dose to the end of treatment (Day 1 in Part 1; Day 10 in Part 2)
CHF6467 Cmax
Maximum Serum Concentration
Measured: From Day 1 pre-dose to the end of treatment (Day 1 in Part 1; Day 10 in Part 2)
CHF6467 tmax
Time corresponding to maximum concentration
Measured: From Day 1 pre-dose to the end of treatment (Day 1 in Part 1; Day 10 in Part 2)
CHF6467 t½
Terminal half-life
Measured: From Day 1 pre-dose to the end of treatment (Day 1 in Part 1; Day 10 in Part 2)
CHF6467 CL/F
Total body clearance
Measured: From Day 1 pre-dose to the end of treatment (Day 1 in Part 1; Day 10 in Part 2)
CHF6467 Vd/F
Apparent volume of distribution
Measured: From Day 1 pre-dose to the end of treatment (Day 1 in Part 1; Day 10 in Part 2)
CHF6467 dose normalized AUC0-24h
Measured: From Day 1 pre-dose to the end of treatment (Day 1 in Part 1; Day 10 in Part 2)
CHF6467 dose normalized AUC0-t
Measured: From Day 1 pre-dose to the end of treatment (Day 1 in Part 1; Day 10 in Part 2)
CHF6467 dose normalized AUC0-∞
Measured: From Day 1 pre-dose to the end of treatment (Day 1 in Part 1; Day 10 in Part 2)
CHF6467 dose normalized Cmax
Measured: From Day 1 pre-dose to the end of treatment (Day 1 in Part 1; Day 10 in Part 2)
CHF6467 concentration in Cerebrospinal fluid (CSF)
Measured: At either 1, 2, 4 or 6 hours post-dose on Day 1 (Part 1) or Day 10 (Part 2)
CHF6467 Antidrug Antibodies (ADA) detection in serum
Measured: From Day 1 pre-dose to last follow-up visit (29 ±3 days after Day 1 for Part 1; 85 ±3 days after Day 1 for Part 2)
CHF6467 Cmin
Minimum Serum Concentration
Measured: Post-dose on Day 9
CHF6467 tmin
Time corresponding to minimum concentration
Measured: Post-dose on Day 9
CHF6467 Cav
Average Serum Concentration
Measured: Post-dose on Day 9
CHF6467 Rac Cmax
Accumulation Ratio considering Cmax
Measured: Comparison Day 9 vs Day 1
CHF6467 Rac AUC0-24h
Accumulation Ratio considering AUC0-24h
Measured: Comparison Day 9 vs Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start15 Sep 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Intervention model
- Parallel groups
- Model description
- Part 1 - SAD (single ascending dose): Randomised, double-blind, placebo-controlled, single-dose escalation, parallel-group design in healthy volunteers (HVs). Part 2 - MAD (multiple ascending dose): Randomised, double-blind, placebo-controlled, repeated-dose escalation, parallel-group design in HVs.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maya Dabcheva, MD, Principal investigator, MC Comac Medical Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163182
- Sponsor's protocol ID
- CLI-06467AC1-02
- Other IDs
- 2025-521455-23-00, 2025
- Status last verified
- Sep 2026
- First submitted
- 24 Jul 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No