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
Summary description of the study
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)
Intervention under investigation
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)
Disease under investigation
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)
Exclusion criteria
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)
Trial sites
Basel
(BASEC)
Sponsor
Mind Medicine Inc. Stimolo Pharma Consulting GmbH
(BASEC)
Contact
Contact Person Switzerland
Shelly Bustion
+41 79 2477143
sbustion@cluttermindmed.coMind Medicine Inc.
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
17.07.2024
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
A Phase 1, Open-label Study Evaluating Relationship Between Multiple Doses of MM120 Oral Solution and Subjective Effects in Healthy Volunteers (BASEC)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
mm120-103-lay-language-summary-de-ch.pdfLink to the results in the primary register
not available