Study on the investigational drug SAN711, placebo-controlled, administered to healthy adults and elderly subjects at multiple ascending oral doses to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics of SAN711 and its interaction with food

2024-514514-12-00 Protocol SAN711-002 Human pharmacology (Phase I) - Other Ended

Start 12 Feb 2025 · End 15 Nov 2025 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol SAN711-002

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Ended
Participants planned 50
Countries 1
Sites 1

Absence Seizure

Key facts

Sponsor
Saniona A/S
Participant type
Healthy volunteers
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Nervous System Diseases [C10]
Trial duration
12 Feb 2025 → 15 Nov 2025
Decision date (initial)
2024-09-16
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

Absence Seizure

VersionLevelCodeTermSystem organ class
21.1 PT 10015496 Essential tremor 100000004852
24.0 PT 10085031 Juvenile absence epilepsy 100000004852
24.0 LLT 10085034 Childhood absence epilepsy 100000004848

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Saniona A/S

Sponsor organisation
Saniona A/S
Address
Smedeland 26b
City
Glostrup
Postcode
2600
Country
Denmark

Scientific contact point

Organisation
Saniona A/S
Contact name
Pierandrea Muglia

Public contact point

Organisation
Saniona A/S
Contact name
Thomas Feldthus

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Italy Ended 50 1
Rest of world — 0 —

Investigational sites

Italy

1 site · Ended
Centro Ricerche Cliniche Di Verona S.r.l.
NA, Piazzale Ludovico Antonio Scuro 10, 37134, Verona

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Italy 2024-09-20 2024-09-23 2025-10-24

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 1 · Art. 38 CTR

Temporary halt TH-64107

Halt date
2024-12-19
Member states concerned
Italy
Publication date
2024-12-19
Reason
Sponsor decision
Explanation
An amendment to the Study Protocol is currently being evaluated by the Sponsor based on the current results.
Benefit-risk balance changed
No
Treatment stopped
Yes

Application history

3 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-06-05 Italy Acceptable
2024-09-02
 2024-09-16
2 SUBSTANTIAL MODIFICATION SM-1 2025-03-07 Italy Acceptable with conditions
2025-05-23
 2025-05-28
3 SUBSTANTIAL MODIFICATION SM-2 2025-05-30 Italy Acceptable
2025-07-08
 2025-07-08