NCT07204171

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

Not yet recruiting Phase 1 Last updated 24 September 2025

What this trial tests

Phase 1 trial testing mitragynine in Safety and Tolerability in Healthy Subjects in 32 participants. Not yet recruiting.

Timeline

1 February 2026

Primary endpoint
1 August 2026

1 August 2026

Quick facts

Lead sponsor	National Institute on Drug Abuse (NIDA)
Phase	Phase 1
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	32
Start date	1 February 2026
Primary completion	1 August 2026
Estimated completion	1 August 2026
Sites	1 location across United States

Drugs / interventions tested

• mitragynine — full drug profile →
• Placebo

Conditions studied

• Safety and Tolerability in Healthy Subjects — all drugs for Safety and Tolerability in Healthy Subjects →

Sponsor

National Institute on Drug Abuse (NIDA)

Who can join

Adults 18 to 65, any sex, with Safety and Tolerability in Healthy Subjects. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Incidence of Treatment-Emergent Adverse Events in Healthy Adult Participants
  Time frame: 4 days in clinic, follow-up on day 7
  The incidence of treatment-emergent adverse events will be measured using a combination of data collection methods, including tracking adverse events and assessing their onset or worsening relative to the initiation of treatment. The most recent version of the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms will be used to classify adverse events, including their relationship

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.