Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
18
Countries
1
Sites
1
Alzheimer's disease
Key facts
- Sponsor
- Alzeca Biosciences Inc.
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- completed 9 Aug 2025
- Decision date (initial)
- 2025-01-17
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-520078-36-00
- EudraCT number
- 2021-003399-14
- ClinicalTrials.gov
- NCT05453539
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Alzheimer's disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10001896 | Alzheimer's disease | 10029205 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Alzeca Biosciences Inc.
- Sponsor organisation
- Alzeca Biosciences Inc.
- Address
- 1800 Bering Drive Suite 850
- City
- Houston
- Postcode
- 77057-3172
- Country
- United States
Scientific contact point
- Organisation
- Alzeca Biosciences Inc.
- Contact name
- Clinical trial coordinators
Public contact point
- Organisation
- Alzeca Biosciences Inc.
- Contact name
- Clinical trial coordinators
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 18 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-13 | Germany | Acceptable 2025-01-14
|
2025-01-17 |