Clinical trial

A Phase 1, First-in-human, Double-blind, Placebo-controlled, Randomized, Single- and Multiple-ascending-dose Study to Determine the Safety, Tolerability, and Pharmacokinetics of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) Administered by Intramuscular Injection in Healthy Subjects

Name

MEO101

Description

The primary objective of the study is to assess the pharmacokinetics, safety, and tolerability of a single-dose and multiple-doses of 5-MeO-DMT administered by intramuscular (IM) injections in healthy subjects.

Trial arms

Trial start

2022-12-27

Estimated PCD

2023-09-07

Trial end

2023-09-07

Status

Completed

Phase

Early phase I

Treatment

5-methoxy-N,N-dimethyltryptamine succinate salt

The 5-MeO-DMT drug product is comprised of the appropriate concentration of 5-MeO-DMT succinate salt drug substance in solution with 0.9% sodium chloride injection solution (USP) in a 5 mL glass vial, and is administered intramuscularly.

Arms:

Cohort 1 - 0.5 mg single-dose, Cohort 2 - 2.5 mg single-dose, Cohort 3 - 4.5 mg single-dose, Cohort 4 - 7 mg single-dose, Cohort 5 - 10 mg single-dose, Cohort 6 - 13 mg single-dose, Cohort 7 - multiple-dose, 3 hour interval, Cohort 8 - multiple-dose, 3 hour interval, Cohort 9 - multiple-dose, 3 hour interval

Other names:

5-MeO-DMT succinate salt, 5-MeO-DMT

Placebo

The placebo is commercially available 0.9% sodium chloride solution (USP) for injection. The placebo is provided by the pharmacy in single-use sterile syringes of the appropriate dose.

Arms:

Other names:

0.9% sodium chloride solution (USP)

Size

Primary endpoint

Number of participants with Treatment Emergent Adverse Events as coded by MedDRA and assessed by CTCAE v4.0

Up to 30 Days

Eligibility criteria

Inclusion Criteria: * Healthy adult male or female. * Aged at least 18 years but not older than 65 years, inclusive. * Body mass index (BMI) within 18.0 kg/m2 to 32.0 kg/m2, inclusive. Exclusion Criteria: * History of significant hypersensitivity to the IP or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs. * Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, or endocrine disorders, as determined by the investigator (or designee). * Participants who, in the opinion of the investigator (or designee), should not participate in this study. * Participant is participating in another study with a medical device or IP within the last 30 days prior to first study drug administration.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'This study will include separate single- and multiple-dose parts.\n\nSingle-dose part:\n\nA double-blind, placebo-controlled, randomized, sequential-group design with 5-MeO-DMT administered by intramuscular injection in 6 cohorts of 6 subjects (randomized as 5 active and 1 placebo subject(s) per group).\n\nMultiple-dose part:\n\nA double-blind, placebo-controlled, randomized, sequential-group design with 5-MeO-DMT administered by intramuscular injection in up to two doses within a single day (3-hour interval) with two different dose levels (6 subjects per group).', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 54, 'type': 'ACTUAL'}}

Updated at

2023-11-30

1 organization

2 products

3 indications

Organization

Usona Institute

Product

5-methoxy-N,N-dimethyltryptamine

Indication

Indication

Indication

Product