Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
81
Countries
1
Sites
1
Inflammatory disease
Key facts
- Sponsor
- Immunorx Pharma Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 24 Jun 2024 → 13 Sep 2024
- Decision date (initial)
- 2023-05-10
- 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
Inflammatory disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10021426 | Immune system disorder (NOS) | 10021428 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Immunorx Pharma Inc.
- Sponsor organisation
- Immunorx Pharma Inc.
- Address
- 1000 North West Street Suite 1200
- City
- Wilmington
- Postcode
- 19801-1058
- Country
- United States
Scientific contact point
- Organisation
- Immunorx Pharma Inc.
- Contact name
- Caroline Fortier
Public contact point
- Organisation
- Immunorx Pharma Inc.
- Contact name
- Caroline Fortier
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 81 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
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 |
|---|---|---|---|---|---|
| Netherlands | 2023-06-07 | 2023-06-07 | 2024-08-27 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-28898
- Halt date
- 2024-06-05
- Planned restart
- 2024-06-18
- Member states concerned
- Netherlands
- Publication date
- 2024-06-11
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- As per protocol, if any possible related SAE occurs, dosing at the current level as well as further dose escalation will be temporarily halted, until written guidance from the sponsor pending a full review of safety and available PK data by the SRC. An SAE meeting these criteria was reported and the study was temporarily halted.
- Follow-up measures
- A review of the Safety Review Committee
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Temporary halt TH-11756
- Halt date
- 2024-01-09
- Planned restart
- 2024-01-23
- Member states concerned
- Netherlands
- Publication date
- 2024-01-23
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- As per protocol, if any possible related SAE occurs, dosing at the current level as well as further dose escalation will be temporarily halted, until written guidance from the sponsor pending a full review of safety and available PK data by the SRC. An SAE meeting these criteria was reported and the study was temporarily halted.
- Follow-up measures
- A review of the Safety Review Committee
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-27 | Netherlands | Acceptable 2023-05-10
|
2023-05-10 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-07-27 | Netherlands | Acceptable 2023-05-10
|
2023-07-27 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2023-11-22 | Netherlands | Acceptable 2023-05-10
|
2023-11-22 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-01-23 | Netherlands | Acceptable 2024-01-24
|
2024-01-24 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-23 | Netherlands | Acceptable 2024-06-11
|
2024-06-11 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-06-14 | Netherlands | Acceptable 2024-06-21
|
2024-06-21 |