Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
36
Countries
1
Sites
1
Treatment of patients poisoned with organophosphorus compounds
Key facts
- Sponsor
- Direction Centrale Du Service De Sante Des Armees
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Musculoskeletal and Neural Physiological Phenomena [G11], Diseases [C] - Disorders of Environmental Origin [C21], Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]
- Trial duration
- 25 Nov 2024 → 24 Apr 2025
- Decision date (initial)
- 2023-12-20
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Treatment of patients poisoned with organophosphorus compounds
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Direction Centrale Du Service De Sante Des Armees
- Sponsor organisation
- Direction Centrale Du Service De Sante Des Armees
- Address
- 1 Place Alphonse Laveran
- City
- Paris
- Postcode
- 75005
- Country
- France
Scientific contact point
- Organisation
- Direction Centrale Du Service De Sante Des Armees
- Contact name
- Dr Rachel HAUS
Public contact point
- Organisation
- Direction Centrale Du Service De Sante Des Armees
- Contact name
- Dr Rachel HAUS
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 36 | 1 |
| 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 |
|---|---|---|---|---|---|
| France | 2024-03-14 | 2025-04-24 | 2024-03-14 | 2024-08-27 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 3 · Art. 38 CTR
Temporary halt TH-44429
- Halt date
- 2024-08-27
- Member states concerned
- France
- Publication date
- 2024-09-05
- Reason
- Sponsor decision, Safety related (clinical or pre-clinical results)
- Explanation
- Communication of existing preclinical data (teratogenicity) that were not already known by the sponsor (not yet published).
- Follow-up measures
- • cohort temporary halted
• modifications or generation of documents for SM5 (in preparation) : investigator brochure, IMPD Vol 2, 2 new addenda for information (one addendum for the previous participants, one for the next participants) - Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-34138
- Halt date
- 2024-06-28
- Member states concerned
- France
- Publication date
- 2024-07-10
- Reason
- Safety related (clinical or pre-clinical results), Sponsor decision
- Follow-up measures
- no subject on treatment currently
stop of healthy volunteer recruitment and product administration in the cohort
additional safety monitoring measures after product administration for next volunteers: increase of blood pressure and heart rate frequency measures in the event of hypotension with or without symptoms. In the event of symptoms, a follow-up electrocardiogram will be performed;
next volunteers will be explicitly informed of the hypotension risk
modifications of protocol, investigator brochure and information note (SM-4 in preparation) - Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-44217
- Halt date
- 2024-08-27
- Member states concerned
- France
- Publication date
- 2024-09-04
- Reason
- Sponsor decision, Safety related (clinical or pre-clinical results)
- Explanation
- Communication of existing preclinical data that were not already known by the sponsor (not yet published).
- Follow-up measures
- • cohort temporary halt
• modifications or generation of documents for SM5 (in preparation) : investigator brochure, IMPD Vol 2, 2 new addenda for information (one addendum for the previous participants, one for the next participants) - Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-24 | France | Acceptable with conditions 2023-12-20
|
2023-12-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-01-26 | France | Acceptable 2024-03-01
|
2024-03-01 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-05-22 | France | Acceptable 2024-03-01
|
2024-05-22 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-06-07 | France | Acceptable 2024-06-18
|
2024-06-18 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-07-03 | France | Acceptable 2024-07-05
|
2024-07-05 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-07-18 | France | Acceptable 2024-07-30
|
2024-07-30 |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-09-27 | France | Acceptable 2024-11-07
|
2024-11-14 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-12-11 | France | Acceptable 2024-11-07
|
2024-12-11 |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-02-28 | France | Acceptable 2025-03-26
|
2025-03-26 |
| 10 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-03-27 | France | Acceptable | 2025-04-10 |