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RecruitingNCT07163182Updated Sep 17, 2026

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 interventional study of CHF6467 Part 1 (SAD) and CHF6467 Part 2 (MAD) in Healthy Volunteers, sponsored by Chiesi Farmaceutici S.p.A.. Recruiting at 1 site in Bulgaria. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Chiesi Farmaceutici S.p.A. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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 fluid) and if the drug CHF6467 causes an immune response by looking for specific molecules, called antibodies that may form against it.

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.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Single Ascending Dose
  • Multiple Ascending Dose
  • Intranasal
  • Cerebrospinal fluid
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Subject's written informed consent obtained prior to any study-related procedures;
  2. Willingness and ability to understand the risks involved and to understand and comply with the study procedures;
  3. Healthy male and female subjects, aged 18-55 years inclusive at screening;
  4. 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;
  5. 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;
  6. 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;
  7. 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;
  8. 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.

  9. Males fulfilling one of the following criteria:

    1. 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
    2. Non-fertile male subjects (contraception is not required in this case) or
    3. Males with partner not of childbearing potential (contraception is not required in this case);

  10. Female subjects fulfilling one of the following criteria:

    1. 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);
    2. WOCBP fulfilling one of the following criteria:

    i. 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).

Exclusion criteria

Exclusion Criteria:

  1. 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;
  2. 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);
  3. Significant nasal congestion or signs of nasal damage, bleeding, excoriation or ulceration at physical examination at screening or Day -1;
  4. History of frequent nosebleeds;
  5. 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;
  6. Clinically significant abnormal 24-hour Holter at screening;
  7. 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;
  8. 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;
  9. 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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
68 participants (estimated)

Study arms

  • Active comparator
    Test Treatment

    Intranasal (IN) CHF6467

    Biological: CHF6467 Part 1 (SAD) · Biological: CHF6467 Part 2 (MAD)

  • Placebo comparator
    Reference Treatment

    Intranasal (IN) placebo

    Drug: Placebo

Interventions

  • BiologicalCHF6467 Part 1 (SAD)

    Intranasal administration of single ascending doses of CHF6467 in 4 different cohorts

  • BiologicalCHF6467 Part 2 (MAD)

    Intranasal administration of multiple ascending doses of CHF6467 in 3 different cohorts

  • DrugPlacebo

    Intranasal administration of matched-placebo of CHF6467 in Part 1 and Part 2

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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)

  2. Vital signs: heart rate (HR)

    Mean absolute value

    Time frame: 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)

  3. Vital signs: body temperature (BT)

    Mean absolute value

    Time frame: 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)

  4. Vital signs: systolic blood pressure (SBP), diastolic blood pressure (DBP)

    * Mean absolute value * Mean change from baseline

    Time frame: 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)

  5. Bedside 12-lead ECG intervals (HR, PR, QRS, QT, QTcF)

    Mean absolute value

    Time frame: 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)

  6. Bedside 12-lead ECG intervals (HR, PR, QRS, QT, QTcF)

    Mean change from baseline

    Time frame: 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)

  7. Bedside 12-lead ECG intervals (HR, PR, QRS, QT, QTcF)

    Mean difference vs. placebo in change from baseline

    Time frame: 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)

  8. 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

    Time frame: 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)

  9. 12-lead ECG parameters extracted from Holter (HR, PR, QRS, QTcF and QT)

    Mean absolute value

    Time frame: From Day 1 pre-dose to 24 hours post-dose (Day 2 in Part 1; Day 11 in Part 2)

  10. 12-lead ECG parameters extracted from Holter (HR, PR, QRS, QTcF and QT)

    Mean change from baseline

    Time frame: From Day 1 pre-dose to 24 hours post-dose (Day 2 in Part 1; Day 11 in Part 2)

  11. 12-lead ECG parameters extracted from Holter (HR, PR, QRS, QTcF and QT)

    Mean difference vs. placebo in change from baseline.

    Time frame: From Day 1 pre-dose to 24 hours post-dose (Day 2 in Part 1; Day 11 in Part 2)

  12. 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

    Time frame: From Day 1 pre-dose to 24 hours post-dose (Day 2 in Part 1; Day 11 in Part 2)

  13. 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

    Time frame: From Day 1 pre-dose to 24 hours post-dose (Day 2 in Part 1; Day 11 in Part 2)

  14. Mean 24-hour heart rate (HR0-24h, from 12-lead Holter recording) and mean hourly HR

    Time frame: From Day 1 pre-dose to 24 hours post-dose

  15. Blood laboratory tests evaluation: chemistry, haematology

    Shift table will be presented by treatment at each post-dose time point

    Time frame: 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)

  16. Blood laboratory tests evaluation: chemistry, haematology

    Mean absolute value will be presented by treatment

    Time frame: 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)

  17. Blood laboratory tests evaluation: chemistry, haematology

    Mean change from baseline (Day -1) will be presented by treatment at each post-dose time point

    Time frame: 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)

  18. Urine laboratory tests evaluation (urine strip): urinalysis

    Urinalysis values will be presented in the listings for each subject

    Time frame: 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

  1. CHF6467 AUC0-24h

    Area under the concentration-time curve from time 0 to 24 h

    Time frame: From Day 1 pre-dose to the end of treatment (Day 1 in Part 1; Day 10 in Part 2)

  2. CHF6467 AUC0-t

    Area Under the Curve from time 0 to time t

    Time frame: From Day 1 pre-dose to the end of treatment (Day 1 in Part 1; Day 10 in Part 2)

  3. CHF6467 AUC0-∞

    Area Under the Curve from time 0 Extrapolated to Infinity

    Time frame: From Day 1 pre-dose to the end of treatment (Day 1 in Part 1; Day 10 in Part 2)

  4. CHF6467 Cmax

    Maximum Serum Concentration

    Time frame: From Day 1 pre-dose to the end of treatment (Day 1 in Part 1; Day 10 in Part 2)

  5. CHF6467 tmax

    Time corresponding to maximum concentration

    Time frame: From Day 1 pre-dose to the end of treatment (Day 1 in Part 1; Day 10 in Part 2)

  6. CHF6467 t½

    Terminal half-life

    Time frame: From Day 1 pre-dose to the end of treatment (Day 1 in Part 1; Day 10 in Part 2)

  7. CHF6467 CL/F

    Total body clearance

    Time frame: From Day 1 pre-dose to the end of treatment (Day 1 in Part 1; Day 10 in Part 2)

  8. CHF6467 Vd/F

    Apparent volume of distribution

    Time frame: From Day 1 pre-dose to the end of treatment (Day 1 in Part 1; Day 10 in Part 2)

  9. CHF6467 dose normalized AUC0-24h

    Time frame: From Day 1 pre-dose to the end of treatment (Day 1 in Part 1; Day 10 in Part 2)

  10. CHF6467 dose normalized AUC0-t

    Time frame: From Day 1 pre-dose to the end of treatment (Day 1 in Part 1; Day 10 in Part 2)

  11. CHF6467 dose normalized AUC0-∞

    Time frame: From Day 1 pre-dose to the end of treatment (Day 1 in Part 1; Day 10 in Part 2)

  12. CHF6467 dose normalized Cmax

    Time frame: From Day 1 pre-dose to the end of treatment (Day 1 in Part 1; Day 10 in Part 2)

  13. CHF6467 concentration in Cerebrospinal fluid (CSF)

    Time frame: At either 1, 2, 4 or 6 hours post-dose on Day 1 (Part 1) or Day 10 (Part 2)

  14. CHF6467 Antidrug Antibodies (ADA) detection in serum

    Time frame: 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)

  15. CHF6467 Cmin

    Minimum Serum Concentration

    Time frame: Post-dose on Day 9

  16. CHF6467 tmin

    Time corresponding to minimum concentration

    Time frame: Post-dose on Day 9

  17. CHF6467 Cav

    Average Serum Concentration

    Time frame: Post-dose on Day 9

  18. CHF6467 Rac Cmax

    Accumulation Ratio considering Cmax

    Time frame: Comparison Day 9 vs Day 1

  19. CHF6467 Rac AUC0-24h

    Accumulation Ratio considering AUC0-24h

    Time frame: Comparison Day 9 vs Day 1

06

Study locations

1 of 1 sites recruiting
  • Bulgaria MC Comac Medical Ltd.
    Sofia, 1618, Bulgaria
    • Maya Dabcheva, MD · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07163182
Lead sponsor
Chiesi Farmaceutici S.p.A.
Responsible party
Sponsor
First posted
Sep 9, 2025
Start date
Sep 15, 2025
Primary completion
Feb 28, 2027 (estimated)
Completion
Feb 28, 2027 (estimated)
Last update
Sep 17, 2026

Study contacts

Chiesi Clinical Trial Info
Contact
clinicaltrials_info@chiesi.com
+39 0521 2791
Maya Dabcheva, MD
principal investigator · MC Comac Medical Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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