Safety and TolerabilityPhase 1NCT06453824
SAD Evaluation of Safety, Tolerability, PK, and PD of MDI-2517 in Healthy Participants
A Phase 1 study testing MDI-2517 in people with Safety and Tolerability, run by MDI Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a Phase 1 study to test the safety and drug effects of MDI-2517 when given once in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety and Tolerability
- What is being tested?
- MDI-2517
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2024to 11 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to understand the study procedures and provide signed informed consent, which includes following the requirements in the informed consent form (ICF) and protocol.
- Healthy male and female participants from 18 to 55 years, at the time of signing the informed consent.
- Body weight of a minimum 50 kg for men and 45 kg for women and body mass index (BMI) within the range of 18.5 to 30 kg/m2.
- Participants who are generally healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Contraceptive use by men or women consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants should be postmenopausal, surgically sterilized, or if of childbearing potential they must agree to use effective contraception throughout the study. Women of childbearing potential and those with less than 24 weeks from menopause must undergo a urine pregnancy test at screening and the result must be negative.
- Participants must not eat Seville oranges, grapefruit or grapefruit juice, pomelos, exotic citrus fruits, grapefruit hybrids, or fruit juices from 7 days before participants check into the clinical site until collection of the final sample.
- Participants must not eat or drink caffeine- or xanthine-containing products (eg, coffee, black/green tea, cola drinks, and chocolate) or energy drinks for 48 hours before participants check into the clinical site until after collection of the final PK and/or PD sample.
- Participants must nor drink alcohol for 24 hours before admission to the clinical site until after collection of the final PK and/or PD sample.
Who cannot join
- Major medical illness or unstable medical condition within 6 months of screening that affect the participant's ability to complete the study procedures follow restrictions, or affect the ability to interpret safety data that would prevent completion of study procedures or assessments.
- Any clinically significant abnormal finding at physical examination. Absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
- Chronic or ongoing active infectious disease requiring systemic treatment
- Any acute infections within 14 days of screening.
- Vaccination received within 1 month of screening.
- Participants known or suspected of not being able to comply with this study (eg, due to alcoholism, drug dependency or psychological disorder).
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- Any clinically significant lab abnormalities
- Abnormal ECG findings
- Abnormal screening estimated glomerular filtration rate
- Positive test results for Hepatitis B, hepatitis C virus antibody, or human immunodeficiency virus (HIV). Negative evaluation for coronavirus disease 2019 (COVID-19).
- History of significant allergic reactions to any drug.
- Use of prescription or nonprescription drugs, including vitamins, herbal and dietary supplements within 7 days or 5 half-lives prior to the first dose of study drug
- Treatment with nonsteroidal anti-inflammatory drugs (NSAIDs, eg, acetylsalicylic acid) or selective serotonin reuptake inhibitors within 7 days prior to screening.
- Positive urine cotinine test. Use of tobacco products or uses other nicotine-containing products from screening until final follow-up visit. Use of cigarettes 3 months before screening until final visit.
- History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 7 units for women or 14 units for men of alcohol per week
- History of drug abuse within 1 year prior to screening or recreational use of soft drugs within 1 month or hard drugs within 3 months prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MDI-2517 in Healthy Participants
This is a Phase 1 study to test the safety and drug effects of MDI-2517 when given once in healthy volunteers.
Read the detailed description
This is a first-in-human study in healthy adult volunteers to assess the safety, tolerability, and pharmacokinetics (PK), with additional exploratory objective to assess pharmacodynamics (PD) of a single dose of MDI-2517.
- Conditions
- Safety and Tolerability
- Being tested
- MDI-2517, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDI-2517Drug
study drug
PlaceboOther
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose (SAD) 1 | Active comparator | MDI-2517 tablet, single oral dose or placebo Receives: Drug: MDI-2517; Other: Placebo |
| SAD 2 | Active comparator | less than or equal to twice the highest MDI2517 dose administered to date, or placebo Receives: Drug: MDI-2517; Other: Placebo |
| SAD 3 | Active comparator | less than or equal to twice the highest MDI2517 dose administered to date, or placebo Receives: Drug: MDI-2517; Other: Placebo |
| SAD 4 | Active comparator | less than or equal to twice the highest MDI2517 dose administered to date, or placebo Receives: Drug: MDI-2517; Other: Placebo |
| SAD 5 | Active comparator | less than or equal to twice the highest MDI2517 dose administered to date, or placebo Receives: Drug: MDI-2517; Other: Placebo |
| SAD 6 | Active comparator | less than or equal to twice the highest MDI2517 dose administered to date, or placebo Receives: Drug: MDI-2517; Other: Placebo |
| SAD 7 | Active comparator | less than or equal to twice the highest MDI2517 dose administered to date, or placebo Receives: Drug: MDI-2517; Other: Placebo |
| SAD 8 | Active comparator | less than or equal to twice the highest MDI2517 dose administered to date, or placebo Receives: Drug: MDI-2517; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the incidence of treatment emergent adverse events [safety and tolerability] of a single-ascending oral dose of MDI-2517 in healthy participants
Adverse reactions to the study drug MDI-2517 will be measured
Measured: 5 days
Secondary outcomes (1)
To evaluate the levels of MDI-2517 in blood plasma following a single oral dose of MDI-2517 in healthy participants
The levels of MDI-2517 in blood plasma following an oral single-dose of MDI-2517 tablets will be measured.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start17 May 2024
- Primary completion11 Nov 2024
- Study completion11 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and TolerabilityStudies 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
- 2 sentinel patients will be treated with one dose of MDI-2517 or placebo and if safe after 48h, 6 additional patients will be dosed (5 on MDI-2517 and 1 on placebo). Progression to enroll the next new group of patients will happen after review of safety and available PK data by the Safety Review Committee (SRC). The SRC will decide to move to the next dose level, decrease the next dose level, repeat a dose level, or to not evaluate any additional doses. Patients are randomized to MDI-2517 or Placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- MDI Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Wyatt, MD, Principal investigator, Syneos Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453824
- Sponsor's protocol ID
- MDI-2517-01-001
- Status last verified
- Mar 2025
- First submitted
- 22 May 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MDI-2517 in Healthy Participants
- ClinicalTrials.gov ID
- NCT06453824
- Acronym / sponsor ID
- MDI-2517-01-001
- Conditions
- Safety and Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- MDI Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 May 2024 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 11 Nov 2024 (actual)
- First posted
- 12 Jun 2024 (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 is a Phase 1 study to test the safety and drug effects of MDI-2517 when given once in healthy volunteers.
Detailed description
This is a first-in-human study in healthy adult volunteers to assess the safety, tolerability, and pharmacokinetics (PK), with additional exploratory objective to assess pharmacodynamics (PD) of a single dose of MDI-2517.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
- Model description
- 2 sentinel patients will be treated with one dose of MDI-2517 or placebo and if safe after 48h, 6 additional patients will be dosed (5 on MDI-2517 and 1 on placebo). Progression to enroll the next new group of patients will happen after review of safety and available PK data by the Safety Review Committee (SRC). The SRC will decide to move to the next dose level, decrease the next dose level, repeat a dose level, or to not evaluate any additional doses. Patients are randomized to MDI-2517 or Placebo.
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose (SAD) 1 | Active comparator | Drug: MDI-2517, Other: PlaceboMDI-2517 tablet, single oral dose or placebo |
| SAD 2 | Active comparator | Drug: MDI-2517, Other: Placeboless than or equal to twice the highest MDI2517 dose administered to date, or placebo |
| SAD 3 | Active comparator | Drug: MDI-2517, Other: Placeboless than or equal to twice the highest MDI2517 dose administered to date, or placebo |
| SAD 4 | Active comparator | Drug: MDI-2517, Other: Placeboless than or equal to twice the highest MDI2517 dose administered to date, or placebo |
| SAD 5 | Active comparator | Drug: MDI-2517, Other: Placeboless than or equal to twice the highest MDI2517 dose administered to date, or placebo |
| SAD 6 | Active comparator | Drug: MDI-2517, Other: Placeboless than or equal to twice the highest MDI2517 dose administered to date, or placebo |
| SAD 7 | Active comparator | Drug: MDI-2517, Other: Placeboless than or equal to twice the highest MDI2517 dose administered to date, or placebo |
| SAD 8 | Active comparator | Drug: MDI-2517, Other: Placeboless than or equal to twice the highest MDI2517 dose administered to date, or placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Able to understand the study procedures and provide signed informed consent, which includes following the requirements in the informed consent form (ICF) and protocol.
- Healthy male and female participants from 18 to 55 years, at the time of signing the informed consent.
- Body weight of a minimum 50 kg for men and 45 kg for women and body mass index (BMI) within the range of 18.5 to 30 kg/m2.
- Participants who are generally healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Contraceptive use by men or women consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants should be postmenopausal, surgically sterilized, or if of childbearing potential they must agree to use effective contraception throughout the study. Women of childbearing potential and those with less than 24 weeks from menopause must undergo a urine pregnancy test at screening and the result must be negative.
Key exclusion criteria (16 listed)
- Major medical illness or unstable medical condition within 6 months of screening that affect the participant's ability to complete the study procedures follow restrictions, or affect the ability to interpret safety data that would prevent completion of study procedures or assessments.
- Any clinically significant abnormal finding at physical examination. Absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
- Chronic or ongoing active infectious disease requiring systemic treatment
- Any acute infections within 14 days of screening.
- Vaccination received within 1 month of screening.
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 |
|---|---|---|
| MDI-2517study drug | Drug | SAD 2, SAD 3, SAD 4, SAD 5, SAD 6, SAD 7, SAD 8, Single Ascending Dose (SAD) 1 |
| Placebomatching placebo | Other | SAD 2, SAD 3, SAD 4, SAD 5, SAD 6, SAD 7, SAD 8, Single Ascending Dose (SAD) 1 |
Primary outcome
To evaluate the incidence of treatment emergent adverse events [safety and tolerability] of a single-ascending oral dose of MDI-2517 in healthy participants
Time frame: 5 days
Adverse reactions to the study drug MDI-2517 will be measured
1 secondary outcome
To evaluate the levels of MDI-2517 in blood plasma following a single oral dose of MDI-2517 in healthy participants
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
David Wyatt, MD principal investigator
Syneos Health
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 MDI-2517 in people with Safety and Tolerability, run by MDI Therapeutics, Inc. 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 16 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: finished, as of the sponsor's last update on 14 Mar 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the incidence of treatment emergent adverse events [safety and tolerability] of a single-ascending oral dose of MDI-2517 in healthy participants (time frame: 5 days). 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 14 Mar 2025.