Kliinilise uuringu otsus nr RKU-4/1

Kirill Munin Worldwide Clinical Trials Limited 4th Floor, East West, Tollhouse Hill 10.01.2025 nr RKU-4/1 NG1 5FS Nottingham SUURBRITANNIA 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 Nooruse 1 / 50411 Tartu / 737 4140 / [email protected] / www.ravimiamet.ee / Registrikood 70003477 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 2 (2)  Kirill Munin Worldwide Clinical Trials Limited 4th Floor, East West, Tollhouse Hill 10.01.2025 nr RKU-4/1 NG1 5FS Nottingham UNITED KINGDOM 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 Nooruse 1 / 50411 Tartu / 737 4140 / [email protected] / www.ravimiamet.ee / Registrikood 70003477 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 2 (2)