Overview
Sponsor-declared trial summary
This is Phase I study to assess the effect on the heart rate (HR) and cardiovascular safety according to electrocardiographic monitoring (including QT and QTc intervals) of CHF6001(Tanimilast) administered with NEXThaler® device in healthy adult volunteers.
Key facts
- Sponsor
- Chiesi Farmaceutici S.p.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 31 Jul 2025 → 13 Oct 2025
- Decision date (initial)
- 2025-06-25
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
This is Phase I study to assess the effect on the heart rate (HR) and cardiovascular safety according to electrocardiographic monitoring (including QT and QTc intervals) of CHF6001(Tanimilast) administered with NEXThaler® device in healthy adult volunteers.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.1 | PT | 10009033 | Chronic obstructive pulmonary disease | 100000004855 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Chiesi Farmaceutici S.p.A.
- Sponsor organisation
- Chiesi Farmaceutici S.p.A.
- Address
- Via Palermo 26 A
- City
- Parma
- Postcode
- 43122
- Country
- Italy
Scientific contact point
- Organisation
- Chiesi Farmaceutici S.p.A.
- Contact name
- GLOBAL CLINICAL DEVELOPMENT
Public contact point
- Organisation
- Chiesi Farmaceutici S.p.A.
- Contact name
- GLOBAL CLINICAL DEVELOPMENT
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 64 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Bulgaria | 2025-07-31 | 2025-07-31 | 2025-09-11 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-97555
- Halt date
- 2025-09-11
- Member states concerned
- Bulgaria
- Publication date
- 2025-09-15
- Reason
- Sponsor decision
- Explanation
- Sponsor strategic considerations
- Follow-up measures
- N/A
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-17 | Bulgaria | Acceptable 2025-06-25
|
2025-06-25 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-29 | Bulgaria | Acceptable 2025-06-25
|
2025-07-29 |