NCT07204171

Phase 1 Study of Oral MG001

Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral MG001

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: National Institute on Drug Abuse (NIDA) · NIH
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This research study is the first time the new medication MG001 is being tested in people. MG001 is a formulation of mitragynine, a compound that comes from a plant called Mitragyna speciosa (sometimes known as kratom), which some people use on their own to help manage symptoms of opioid withdrawal. The purpose of this study is to understand how safe MG001 is, how well it is tolerated, and how the body processes it. About 32 healthy adult volunteers, both men and women, will take part. Before joining, participants will undergo screening tests up to four weeks in advance to make sure they are eligible and healthy enough. On the day before dosing, participants will be admitted to the clinic for final health checks, and those who qualify will be randomly assigned-by chance, like flipping a coin-to receive either a single dose of MG001 or a placebo (an inactive substance). Neither the participants nor the staff giving the medicine will know which one is given. The study drug will be administered after at least 10 hours of fasting, and participants will then remain in the research clinic under close medical observation for three nights, until Day 4. During this time, doctors and nurses will monitor participants' health, look for any side effects, and collect blood samples to see how MG001 moves through the body. A follow-up clinic visit on Day 7 will provide one last check-in and blood test. This design helps researchers gather important first information on the safety and tolerability of MG001, while protecting the health and well-being of participants.

Detailed description

This first in human (FIH), randomized, double-blind, placebo-controlled, single ascending dose (SAD) phase I study in healthy participants is designed to assess the safety and tolerability of MG001. Approximately 32 healthy male and female volunteers will be enrolled. Participants will be screened for eligibility as outpatients and inpatients. Outpatient screening will occur between Day -28 and Day -2. On Study Day -1, participants will undergo the clinic intake to screen for continued eligibility. Once a participant has been determined to be eligible, the participant will be randomized to receive either MG001 or placebo. Participants will receive the assigned treatment on Day 1 after participants have fasted for at least 10 hours. Safety and PK assessments will start on Day 1 and continue until discharge. Participants will be discharged from the research clinic on Day 4 and seen for a follow-up visit on Day 7 , when the last PK sample will be collected.

Conditions

• Safety and Tolerability in Healthy Subjects

Interventions

Type	Name	Description
DRUG	mitragynine	Mu opioid receptor partial agonist
DRUG	Placebo	Each of the four dose groups of n=8 participants will be assigned to active drug or placebo in the ration 6:2.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2025-10-02
• Last updated: 2025-10-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study