A randomized, multiple ascending doses, clinical trial to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of CV-01 after double-blind, placebo-controlled multiple oral administrations for 2 weeks in healthy volunteers, and multiple oral administrations open-label for 2 weeks in a cohort of participants with drug resistant epilepsy

2026-525478-21-00 Protocol 175(A)MD25105 Human pharmacology (Phase I) - Other Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 2 sites · Protocol 175(A)MD25105

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Authorised, recruitment pending
Participants planned 36
Countries 1
Sites 2

Drug resistant epilepsy

Key facts

Sponsor
Angelini Pharma Italia Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Enunciabile Anche Angelini Pharma Italia S.p.A. Angelini Pharma S.p.A. A.C.R.A.F. S.p.A. Acraf S.p.A. Angelini S.p.A. aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.
Participant type
Patients, Healthy volunteers
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Nervous System Diseases [C10]
Decision date (initial)
2026-06-08
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

Drug resistant epilepsy

VersionLevelCodeTermSystem organ class
20.0 LLT 10032061 Other forms of epilepsy 10029205
21.0 PT 10015037 Epilepsy 100000004852

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Angelini Pharma Italia Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Enunciabile Anche Angelini Pharma Italia S.p.A. Angelini Pharma S.p.A. A.C.R.A.F. S.p.A. Acraf S.p.A. Angelini S.p.A. aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.

Sponsor organisation
Angelini Pharma Italia Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Enunciabile Anche Angelini Pharma Italia S.p.A. Angelini Pharma S.p.A. A.C.R.A.F. S.p.A. Acraf S.p.A. Angelini S.p.A. aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.
Address
Viale Amelia 70
City
Rome
Postcode
00181
Country
Italy

Scientific contact point

Organisation
Angelini Pharma Italia Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Enunciabile Anche Angelini Pharma Italia S.p.A. Angelini Pharma S.p.A. A.C.R.A.F. S.p.A. Acraf S.p.A. Angelini S.p.A. aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.
Contact name
Valeria Tellone

Public contact point

Organisation
Angelini Pharma Italia Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Enunciabile Anche Angelini Pharma Italia S.p.A. Angelini Pharma S.p.A. A.C.R.A.F. S.p.A. Acraf S.p.A. Angelini S.p.A. aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.
Contact name
Valeria Tellone

Locations

1 EU/EEA country · 2 investigational sites

By country

CountryMS statusPlanned subjectsSites
Sweden Authorised, recruitment pending 36 2
Rest of world — 0 —

Investigational sites

Sweden

2 sites · Authorised, recruitment pending
CTC Clinical Trial Consultants AB
CTC GoCo, Göteborg, Vetenskapens Graend 11, 431 53, Moelndal
CTC Clinical Trial Consultants AB
CTC Sjukhuskliniken, Uppsala, Ingang 85 Vaning 2, 751 85, Uppsala

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2026-04-20 Sweden Acceptable
2026-06-08
 2026-06-08

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