An open phase I study to assess the relationship between multiple doses of the MM120 solution to be ingested and subjective effects in healthy volunteers
Descrizione riassuntiva dello studio
Mind Medicine Inc. (MindMed) is developing a form of D-Lysergsäurediethylamid (LSD) called MM120 for the treatment of generalized anxiety disorder (GAD). MM120 (LSD-D-Tartrate) is an ingestible hallucinogen. The sponsor has conducted three clinical studies with MM120. In a large-scale study, the efficacy of MM120 was demonstrated in patients with GAD. The purpose of the MM120-103 study is to assess the possibility of increasing the MM120 dose from 20 micrograms to 100 micrograms without changing the drug's effect. This study, which will be conducted at a single Swiss hospital, will enroll up to twenty healthy volunteers. During the study, participants will undergo clinical tests to ensure their eligibility for MM120 administration. This phase of the study is called screening. If everything is in order, participants will receive MM120 at the lowest dose. Depending on how well they tolerate the dose, they may receive higher doses of MM120. The study lasts up to 43 days, including 21 days for screening, up to 8 days for dosing, and 14 days for subsequent safety assessments. Based on the results of this study, follow-up studies will be conducted to examine whether MM120 continues to provide the same benefits when the perceptible effects of the drug are reduced.
(BASEC)
Intervento studiato
Mind Medicine Inc. (MindMed) is developing a form of D-Lysergsäurediethylamid (LSD) called MM120 for the treatment of generalized anxiety disorder (GAD). MM120 (LSD-D-Tartrate) is an ingestible hallucinogen.
(BASEC)
Malattie studiate
Only healthy volunteers are participating in this study. The development of the investigational drug MM120 aims to treat generalized anxiety disorder (GAD).
(BASEC)
1. At Visit 1: Participants aged 18 to 65 years inclusive. 2. Healthy, as determined by a physician (or designee) based on medical history and all eligibility assessments. 3. Suitable venous access for cannulation and repeated blood sampling. (BASEC)
Criteri di esclusione
1. Women of childbearing potential who do not wish or cannot use a highly effective contraceptive method for the duration of the study (from screening to the last visit of the participant), OR Men who are physiologically capable of fathering a child and are sexually active with a woman of childbearing potential, but do not wish or cannot use a mechanical barrier method for contraception (e.g., condoms with or without spermicide cream or gel; the fertile partner must be asked to use a highly effective contraceptive method from screening to the last visit of the participant). 2. Women who are currently pregnant or breastfeeding or who wish to become pregnant or breastfeed during the study. 3. Sperm or egg donation or retrieval during the study. (BASEC)
Luogo dello studio
Basilea
(BASEC)
Sponsor
Mind Medicine Inc. Stimolo Pharma Consulting GmbH
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Shelly Bustion
+41 79 2477143
sbustion@cluttermindmed.coMind Medicine Inc.
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
17.07.2024
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
A Phase 1, Open-label Study Evaluating Relationship Between Multiple Doses of MM120 Oral Solution and Subjective Effects in Healthy Volunteers (BASEC)
Titolo accademico
non disponibile
Titolo pubblico
non disponibile
Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
non disponibile
Risultati dello studio
Riepilogo dei risultati
mm120-103-lay-language-summary-de-ch.pdfLink ai risultati nel registro primario
non disponibile