Kliinilise uuringu otsus nr RKU-4/1

Nooruse 1 / 50411 Tartu / 737 4140 / [email protected] / www.ravimiamet.ee / Registrikood 70003477

10.01.2025 nr RKU-4/1

OTSUS

Ravimi kliinilise uuringu loa andmiseks Euroopa Parlamendi ja nõukogu määruse (EL) nr

536/2014 (määrus (EL) 536/2014) alusel

Uuringu sponsor Angitia Inc. Ltd., keda käesolevas menetluses esindab Worldwide Clinical

Trials Limited, esitas 06.09.2024 Ravimiametile taotluse ravimi kliinilise uuringu

teostamiseks määruse (EL) 536/2014 artikli 5 (1) ja ravimiseaduse (RavS) § 991 lõikes 1

sätestatud tingimustel.

Tuginedes määruse (EL) 536/2014 artiklile 8, hindamisaruande I ja II osaga hõlmatud aspekte

hinnates, otsustab Ravimiamet ravimiseaduse § 996 lg 1 punkti 2 ja lõike 3 alusel

anda uuringu sponsorile Angitia Inc. Ltd. loa ravimi kliinilise uuringu läbiviimiseks vastavalt

esitatud uuringuplaanile nr ACT23-001 järgmistel tingimustel:

uuringuplaani number: ACT23-001 (versioon 3.1, kuupäevaga 22. november 2024)

uuringu referentsnumber: 24-023

uuringu nimetus: II faasi randomiseeritud topeltpime platseebokontrolliga paralleelrühmaga

annuse leidmise uuring AGA2118 ohutuse, talutavuse ja efektiivsuse hindamiseks väikese

luutihedusega postmenopausis naistel

uuringu sponsor: Angitia Inc. Ltd.

uuritavate arv Eestis: 25

uuringu algus: uuringu alustamise tingimused on välja toodud Clinical Trials Information

System’is (CTIS), EU CT 2024-515610-41-00, taotluse ID 28895

vastutavad uurijad ja uuringukeskused:

- Dr Raili Müller, MediTrials OÜ, Mõisavahe tn 34c, 50708 Tartu, Eesti

- Dr Ivo Valter, Center for Clinical and Basic Research AS, J. Pärna tn 4, 10128 Tallinn,

Eesti

- Dr Andres Pille, Ida-Tallinna Keskhaigla, Pärnu mnt 104, 11312 Tallinn, Eesti

Kirill Munin

Worldwide Clinical Trials Limited

4th Floor, East West, Tollhouse Hill

NG1 5FS Nottingham

SUURBRITANNIA

2 (2)

Vaide käesolevale otsusele saab esitada Ravimiametile 30 päeva jooksul arvates otsuse

teatavaks tegemisest vastavalt haldusmenetluse seaduse § 71 lõikele 1. Kui otsuse saaja soovib

otsust vaidlustada halduskohtus, võib ta vastavalt halduskohtumenetluse seadustiku § 7 lõikele

1 ja § 46 lõikele 1 esitada kaebuse otsuse peale Tartu Halduskohtule 30 päeva jooksul otsuse

teatavaks tegemisest arvates.

Lugupidamisega

(allkirjastatud digitaalselt)

Katrin Kiisk

Peadirektor

Nooruse 1 / 50411 Tartu / 737 4140 / [email protected] / www.ravimiamet.ee / Registrikood 70003477

10.01.2025 nr RKU-4/1

DECISION

to grant authorisation for clinical trial on the basis of Regulation (EU) No 536/2014 of the

European Parliament and of the council

State Agency of Medicines has received the application from sponsor Angitia Inc. Ltd. on

06.09.2024 to conduct a clinical trial under the conditions stipulated in Regulation (EU) No

536/2014 art 5 (1) and § 991 (1) of Estonian Medicinal Products Act (MPA).

Based on art 8 of Regulation (EU) No 536/2014, considering the aspects covered by Part I and

Part II of the assessment report, on the basis of § 996 section 1 p 2 and (3) of Medicinal Product

Act

State Agency of Medicines has decided to give the approval to conduct the clinical study

protocol no ACT23-001 under the following conditions:

protocol no: ACT23-001 (Version 3.1, dated November 22, 2024)

full title of the trial: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-

Group, Dose-Finding Study to Evaluate the Safety, Tolerability and Efficacy of AGA2118 in

Postmenopausal Women with Low Bone Mineral Density

sponsor of the trial: Angitia Inc. Ltd.

number of subjects in Estonia: 25

starting date: the conditions to start the trial are specified within Clinical Trials Information

System (CTIS) under EU CT 2024-515610-41-00, application ID 28895

principal investigators and study locations:

- Dr Raili Müller, MediTrials OÜ, Mõisavahe tn 34c, 50708 Tartu, Estonia

- Dr Ivo Valter, Center for Clinical and Basic Research AS, J. Pärna tn 4, 10128 Tallinn,

Estonia

- Dr Andres Pille, East Tallinn Central Hospital, Pärnu mnt 104, 11312 Tallinn, Estonia

The addressee may file a challenge with State Agency of Medicines within 30 days as of the

day when the addressee became or should have become aware of the decision as prescribed in

Kirill Munin

Worldwide Clinical Trials Limited

4th Floor, East West, Tollhouse Hill

NG1 5FS Nottingham

UNITED KINGDOM

2 (2)

Code of Administrative Procedure § 71(1). If the addressee wishes to have the decision to

annulled by the administrative court, he or she may submit a complaint to the Tartu

Administrative Court as prescribed in § 7(1) and § 46(1) of the Code of Administrative Court

Procedure within 30 days after the date on which the decision was notified to the applicant.

(digitally signed)

Katrin Kiisk

Director General