Safety and Tolerability in Healthy SubjectsPhase 1NCT07204171
Phase 1 Study of Oral MG001
A Phase 1 study testing mitragynine in people with Safety and Tolerability in Healthy Subjects, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety and Tolerability in Healthy Subjects
- What is being tested?
- mitragynine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is a healthy male or female volunteer between 18 and 65 years of age, inclusive, at the time of consent.
- Has a body mass index (BMI) within the range of 18.0 to 32.0 kg/m2 and a minimum weight of at least 50.0 kg at screening.
- Has a recent history of oral opioid use , defined as using prescription or recreational oral opioids at least once during the 30-day period preceding screening.
- Is able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study.
- Has no clinically significant concurrent medical conditions determined by medical history, physical examination, clinical laboratory test , vital signs, and 12-lead ECG.
- A female study participant must be of non-childbearing potential - should be surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, bilateral salpingectomy or tubal ligation/occlusion) or in a menopausal state (at least 1 year without menses), as confirmed by follicle stimulating hormone (FSH) levels (≥40 mIU/mL).
- If a male study participant that engages in sexual activity that has the risk of pregnancy, must agree to use a double barrier method (e.g., condom and spermicide) and agree to not donate sperm during the study and for at least 90 days after the last dose of the study medication.
- Is able and willing to comply with protocol requirements and the rules and regulations of the study site and is likely to complete all the study treatments.
Who cannot join
- Has any clinically significant finding within one year of Screening on medical history, physical examination, complete neurological examination, clinical laboratory test, vital signs (including hemoglobin saturation assessed by pulse oximetry, RR, HR, BP, oral body temperature ), or ECGs that contraindicate participation in the study. This includes but is not limited to history of or current cardiac, hepatic, renal, neurologic, gastrointestinal (GI) , pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy.
- Has clinically significant psychiatric symptoms and/or psychiatric comorbidities (schizophrenia, bipolar disorders, mania, unipolar depression, disruptive behaviors, etc.), or a history of such within one year of screening. Psychiatric assessment will be conducted by a Qualified Mental Health Professional using the Mini-International Neuropsychiatric Interview (MINI).
- Has a history of suicide attempts or evidence of suicidal ideation based on the Columbia-Suicide Severity Rating Scale (C-SSRS):
- Any lifetime history of serious or recurrent suicidal behavior.
- Previous history of suicidal behaviors in the past 10 years.
- Suicidal ideation with or without a plan (active or passive, respectively) in the past year.
Show all 19Show fewer
- Has a history of epilepsy, seizure disorder, or head trauma with neurological sequelae (e.g., loss of consciousness that required hospitalization); current anorexia nervosa or bulimia; or any other conditions that increase seizure risk in the opinion of the study clinician.
- Has a history of thyroid and/or parathyroid disease or abnormal T4 or PTH levels.
- Has evidence of second or third degree heart block, atrial fibrillation, atrial flutter, prolongation of the QTc, or any other finding on the screening ECG that, in the opinion of the study medical clinician, would preclude safe participation in the study.
- Has any clinically significant abnormal laboratory values
- Has taken kratom or any investigational drug in another study within 30 days of study consent.
- Requires treatment with opioid-containing medications (e.g., opioid analgesics) during the study period.
- Has used opioids intravenously or on 3 or more consecutive days during the 30 day period preceding screening.
- Has a sitting systolic blood pressure (SBP) >140 mmHg, diastolic BP (DBP) >90 mmHg or HR <50 or >100 beats per minute (BPM) at screening and clinic intake.
- Has orthostatic hypotension, defined as a 20 mmHg reduction in SBP and 10 mmHg in DBP.
- Has an O2 saturation, defined as the percentage of hemoglobin in the blood that is carrying oxygen, below 95% from a 10 second reading.
- Has donated blood (excluding plasma donation) of approximately 500 mL within 56 days prior to screening.
- Has donated plasma within 7 days prior to screening.
- Has taken any concomitant medications, including prescription, over-the-counter, dietary supplements, herbal products, vitamins, or medications interacting with CYP3A4, CYP2D6, or CYP1A2 within 14 days or 5-half-lives (whichever is longer) prior to study drug administration, and throughout the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Altasciences Clinical Kansas
Overland Park, Kansas, 66212
Debra Kelsh, MD, 913-696-1601, DKelsh@altasciences.com
About this study
Official title: Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral MG001
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.
Read the 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.
- Being tested
- mitragynine, Placebo
- Keywords
- mitragynine, kratom, opioid use disorder, opioid withdrawal
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mitragynineDrug
Mu opioid receptor partial agonist
PlaceboDrug
Each of the four dose groups of n=8 participants will be assigned to active drug or placebo in the ration 6:2.
| Study group | Role | What they receive |
|---|---|---|
| 25 mg dose | Experimental | oral administration in fasted state Receives: Drug: mitragynine |
| 50 mg dose | Experimental | oral administration in fasted state Receives: Drug: mitragynine |
| 75 mg dose | Experimental | oral administration in fasted state Receives: Drug: mitragynine |
| 100 mg dose | Experimental | oral administration in fasted state Receives: Drug: mitragynine |
| Placebo | Placebo comparator | oral administration in fasted state Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events in Healthy Adult Participants
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 to the treatment and maximum severity. Events will be identified either through subject self-report or clinically significant abnormal findings on: (i) Physical examination (ii) Vital signs assessments (heart rate (BPM), blood pressure (mmHg), respiration rate (BPM), hemoglobin saturation (%) and temperature (F)) (iii) ECG assessment (QTcF) as determined by the Investigator/consulting board-certified cardiologist (iv) pupil constriction (mm) (v) sedation as measured by VAS (score) and MOAA/S (score (vi) Clinical Laboratory Assessments
Measured: 4 days in clinic, follow-up on day 7
Secondary outcomes (4)
Cmax
maximum observed plasma concentration (ng/mL)
Measured: 144 hours
AUC
area under the concentration-time curve (mg*h/L)
Measured: 144 hours
Tmax
time of maximum observed plasma concentration (hours)
Measured: 144 hours
half-life (t1/2)
MG001 elimination half-life (hours)
Measured: 144 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study startSep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and Tolerability in Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This is first-in-human (FIH), randomized, double-blind, placebo-controlled, single ascending dose (SAD), phase I study in healthy participants. Four single ascending dose levels under fasting conditions are proposed.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Altasciences Company Inc., Technical Resources International, Inc.
- Responsible party
- Sponsor
- Investigators
- Julia Solarczyk Donnelly, MS, RAC, Study director, National Institute on Drug Abuse, NIH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204171
- Sponsor's protocol ID
- NIDA-MG001-Ph1a-001
- Other IDs
- 75N95023D20019
- Status last verified
- Sep 2025
- First submitted
- 24 Sep 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral MG001
- ClinicalTrials.gov ID
- NCT07204171
- Acronym / sponsor ID
- NIDA-MG001-Ph1a-001
- Keywords
- mitragynine, kratom, opioid use disorder, opioid withdrawal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Collaborators
- Altasciences Company Inc., Technical Resources International, Inc.
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- This is first-in-human (FIH), randomized, double-blind, placebo-controlled, single ascending dose (SAD), phase I study in healthy participants. Four single ascending dose levels under fasting conditions are proposed.
| Arm | Type | Receives |
|---|---|---|
| 25 mg dose | Experimental | Drug: mitragynineoral administration in fasted state |
| 50 mg dose | Experimental | Drug: mitragynineoral administration in fasted state |
| 75 mg dose | Experimental | Drug: mitragynineoral administration in fasted state |
| 100 mg dose | Experimental | Drug: mitragynineoral administration in fasted state |
| Placebo | Placebo comparator | Drug: Placebooral administration in fasted state |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Is a healthy male or female volunteer between 18 and 65 years of age, inclusive, at the time of consent.
- Has a body mass index (BMI) within the range of 18.0 to 32.0 kg/m2 and a minimum weight of at least 50.0 kg at screening.
- Has a recent history of oral opioid use , defined as using prescription or recreational oral opioids at least once during the 30-day period preceding screening.
- Is able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study.
- Has no clinically significant concurrent medical conditions determined by medical history, physical examination, clinical laboratory test , vital signs, and 12-lead ECG.
Key exclusion criteria (19 listed)
- Has any clinically significant finding within one year of Screening on medical history, physical examination, complete neurological examination, clinical laboratory test, vital signs (including hemoglobin saturation assessed by pulse oximetry, RR, HR, BP, oral body temperature ), or ECGs that contraindicate participation in the study. This includes but is not limited to history of or current cardiac, hepatic, renal, neurologic, gastrointestinal (GI) , pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy.
- Has clinically significant psychiatric symptoms and/or psychiatric comorbidities (schizophrenia, bipolar disorders, mania, unipolar depression, disruptive behaviors, etc.), or a history of such within one year of screening. Psychiatric assessment will be conducted by a Qualified Mental Health Professional using the Mini-International Neuropsychiatric Interview (MINI).
- Has a history of suicide attempts or evidence of suicidal ideation based on the Columbia-Suicide Severity Rating Scale (C-SSRS):
- Has a history of epilepsy, seizure disorder, or head trauma with neurological sequelae (e.g., loss of consciousness that required hospitalization); current anorexia nervosa or bulimia; or any other conditions that increase seizure risk in the opinion of the study clinician.
- Has a history of thyroid and/or parathyroid disease or abnormal T4 or PTH levels.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mitragynineMu opioid receptor partial agonist | Drug | 100 mg dose, 25 mg dose, 50 mg dose, 75 mg dose |
| PlaceboEach of the four dose groups of n=8 participants will be assigned to active drug or placebo in the ration 6:2. | Drug | Placebo |
Primary outcome
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 to the treatment and maximum severity. Events will be identified either through subject self-report or clinically significant abnormal findings on: (i) Physical examination (ii) Vital signs assessments (heart rate (BPM), blood pressure (mmHg), respiration rate (BPM), hemoglobin saturation (%) and temperature (F)) (iii) ECG assessment (QTcF) as determined by the Investigator/consulting board-certified cardiologist (iv) pupil constriction (mm) (v) sedation as measured by VAS (score) and MOAA/S (score (vi) Clinical Laboratory Assessments
4 secondary outcomes
Cmax
Time frame: 144 hours
AUC
Time frame: 144 hours
Tmax
Time frame: 144 hours
half-life (t1/2)
Time frame: 144 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julia Solarczyk Donnelly, MS, RAC study director
National Institute on Drug Abuse, NIH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mitragynine in people with Safety and Tolerability in Healthy Subjects, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Debra Kelsh, MD (913-696-1601, DKelsh@altasciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events in Healthy Adult Participants (time frame: 4 days in clinic, follow-up on day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.