Opioid Use DisorderEarly Phase 1NCT07602335
Safety, Tolerability, and Pharmacokinetics of MCAM in Healthy Adult Participants
A Early Phase 1 study testing MCAM in people with Opioid Use Disorder, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
The goal of this clinical trial is to test the safety and to see if there are any side effects of the investigational drug, MCAM. The main aim is to measure blood levels of the study drug after oral administration. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- MCAM
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2026to 31 Dec 2027
- Phase
- Early 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is willing and able to provide informed consent and comply with all protocol requirements
- Is aged ≥18 years and ≤55 years at time of informed consent
- Has a body mass index (BMI) between 18.0 and 32.0 kg/m2 and body weight (BW) not lower than 50 kg
- Participant is a nonsmoker (for at least 3 months prior to Screening) and does not use tobacco-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, or nicotine patch or gum)
- Has Blood pressure (BP) and Heart rate (HR) within the normal range at the Screening visit after 5 minutes in a seated position:
- Systolic BP between 90 and 145 mmHg
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- Diastolic BP between 60 and 90 mmHg
- HR between 60 and 90 beats per minute
- Electrocardiogram (ECG) is normal based on 12-lead ECG assessment at Screening:
- ECG PR interval between 120 and 200 ms
- ECG QRS interval <100 ms
- ECG QT interval (corrected) (QTc) with Fridericia formula (QTcF) <450 ms and no history of additional risk factors for Torsades de pointes (TdP)
- No sign of any sinus node dysfunction
- Has clinical laboratory parameters (hematology [including coagulation], clinical chemistry, and urinalysis) within normal ranges. Individual values out of the normal range may be acceptable if judged clinically insignificant by an Investigator.
- Has not been dosed in an interventional clinical drug trial within 30 days prior to screening or within 5 half-lives of the last dose of study drug, whichever is longer.
- If female, participants who are not of childbearing potential should be surgically sterile (e.g., have undergone hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or tubal ligation/occlusion) or in a post-menopausal state (at least one year without menses). Female participants of childbearing potential will use a highly effective (i.e., failure rate of <1%) method of contraception throughout the study and for at least five half-lives following MCAM dosing. Methods of contraception that are considered to be highly effective with a failure rate of <1% that are appropriate for this study include the following: a) intrauterine device (IUD)/intrauterine system (IUS); b) implantable rod; c) bilateral tubal occlusion; d) complete abstinence from sexual intercourse; and e) infertile male partner (e.g., vasectomized [with documented evidence of azoospermia], permanently sterile following bilateral orchidectomy, or any other documented cause of infertility).
- If female, must have a negative serum or urine pregnancy test at Screening and a negative serum or urine test at Admission (day 1)
- Male participants who report surgical sterilization will be required to confirm sterility by post-vasectomy semen analysis (PVSA). Participants in whom PVSA confirmation cannot be obtained will be required to use a double-barrier method (e.g., condom with spermicide), same as for the rest of the male participants, or agree to remain abstinent from heterosexual intercourse at the time of Screening, during the study, and for at least five half-lives following MCAM dosing.
- If male, participants must agree not to donate sperm for the duration of the study and for 90 days after the last dose of study drug.
Who cannot join
- Any significant acute or chronic medical illness
- Any history of cancer within 5 years of enrollment, with the exception of fully resected skin basal cell carcinoma
- Any major hospitalization or surgery 3 months prior to study drug administration
- Has donated or experienced a blood loss of 500 mL or more within 56 days prior to Screening or has donated plasma within 7 days prior to Screening
- Poor venous access assessed at Screening
- Has ever participated or plans to participate in a substance or alcohol rehabilitation program to treat their substance or alcohol dependence. If participation in a rehabilitation program was court-mandated as part of a plea agreement, entry may be permissible at an Investigator's discretion
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- Any history of substance use disorder) as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5; e.g. a score of ≥2, within a 12-month period) or recent use of an opioid-containing product (e.g., codeine) within 6 months prior to study drug administration
- History of, or currently diagnosed with, any clinically significant psychiatric disorder (based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition [DSM-5] and Mini International Neuropsychiatric Interview [MINI] criteria), which in the opinion of an Investigator could interfere with study participation or study data collection
- History of any suicidal ideation within the past 6 months or a lifetime history of suicidal behavior, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
- Any neurological, renal, cardiac, hepatic, or other medical condition that could interfere with study assessments as determined by and Investigator, or Sponsor
- Any significant illness or infection, as determined by an Investigator or Sponsor, within the prior 30 days
- Positive urine alcohol or urine drug screen for substance of abuse at Screening
- Must not be physically dependent on opioids, as demonstrated by successful completion of the naloxone challenge
- Known hypersensitivity to any component of the MCAM drug product, naloxone, or placebo
- Use of any prescription or over-the-counter medications (such as antacids, vitamins, minerals, dietary/herbal preparations, St. John's Wort, and nutritional supplements) within 14 days prior to Screening or 5 half-lives prior to the study
- Positive screen for hepatitis B surface antigen (HBsAg), Hepatitis C (HCV) antibody, or HIV-1 and HIV-2 antibodies
- Have a procedure planned that would require the use of opioids for pain management within at least 2 weeks after the conclusion of the study (participants may be resistant to opioids for two weeks or longer after study participation)
- Is likely, in the opinion of an Investigator, to be non-compliant or uncooperative with study procedures for any reason
- If female, are pregnant, nursing, or planning to become pregnant during 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
Dr. Vince Clinical Research
Overland Park, Kansas, 66212
Benjamin Sundling, DO, 913-333-3000, bsundling@drvince.com
About this study
Official title: A Phase 1, First-In-Human, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of MCAM in Randomized Healthy Adult Participants (Double-Blind)
The goal of this clinical trial is to test the safety and to see if there are any side effects of the investigational drug, MCAM. The main aim is to measure blood levels of the study drug after oral administration.
Researchers will compare the active study drug to a placebo to test for any differences between the two groups.
Participants will be screened for up to 28 days before starting study treatment. Following the screening visit, participants will be admitted to a clinic for 4 days for treatment with either the study drug or placebo. They will attend a follow-up visit on Days 5 and 7 and participate in a follow-up phone call on Day 8. Three different doses will be tested to find the highest safe dose.
Read the detailed description
A Single ascending dose (SAD) will be administered to evaluate safety, tolerability and pharmacokinetics (PK) of MCAM.
MCAM will be dosed orally to healthy adult participants at one of 3 dose levels: 3, 10, or 30 mg or a matching placebo.
- Conditions
- Opioid Use Disorder
- Being tested
- Placebo, MCAM
- Keywords
- Healthy participants, μ-Opioid Receptor
- 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.
PlaceboOther
Also called methylcellulose solution
A 1% methylcellulose solution will be dosed orally using an amber syringe to maintain blinding.
MCAMDrug
MCAM will be dosed orally as a 3, 10, or 30 mg suspension in an amber syringe to maintain blinding.
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Group (SAD) MCAM | Experimental | MCAM will be dosed orally using 3 dose levels: 3, 10 and 30 mg free base on Day 1. Receives: Drug: MCAM |
| Single Ascending Group Placebo | Placebo comparator | Participants randomized to placebo will receive 1% methylcellulose solution on Day 1. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single Ascending Dose (SAD): Cmax
Maximum plasma concentration in the blood after administration
Measured: Baseline to 96 hours
SAD: Tmax
Time to maximum concentration of drug in the blood
Measured: Baseline to 96 hours
SAD: T1/2
Known as the "plasma half-life," this is the time required for the concentration of a substance (like a drug) in blood plasma to decrease by half its initial value.
Measured: Baseline to 96 hours
SAD: Area under the curve from 0-24 hours
Area under the plasma concentration time curve from time 0 to 24 hours
Measured: Baseline to 96 hours
SAD: Area under the curve from 0-t
Area under the plasma concentration time curve from time 0 to the last measurable concentration
Measured: Baseline to 96 hours
SAD: Area under the curve from 0-infinity
Area Under the Curve from time zero to infinity (AUC 0-infinity) is a fundamental pharmacokinetic parameter representing the total drug exposure over time, from administration until the drug is completely eliminated. It measures the entire extent of absorption, distribution, metabolism, and excretion.
Measured: Baseline to 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start22 Oct 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A phase 1, first-in-human, placebo-controlled study. A dose escalation to determine maximum tolerable dose.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Benjamin Sundling, DO, Principal investigator, Dr. Vince Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602335
- Sponsor's protocol ID
- UTHSCSA-MCAM-101
- Other IDs
- U01DA060704
- Status last verified
- Oct 2026
- First submitted
- 15 May 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results of the study will be used for the purposes of national and international registration, publication, and information for medical and pharmaceutical professionals.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-In-Human, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of MCAM in Randomized Healthy Adult Participants (Double-Blind)
- ClinicalTrials.gov ID
- NCT07602335
- Acronym / sponsor ID
- UTHSCSA-MCAM-101
- Conditions
- Opioid Use Disorder
- Keywords
- Healthy participants, μ-Opioid Receptor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 22 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 May 2026 (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.
The goal of this clinical trial is to test the safety and to see if there are any side effects of the investigational drug, MCAM. The main aim is to measure blood levels of the study drug after oral administration.
Researchers will compare the active study drug to a placebo to test for any differences between the two groups.
Participants will be screened for up to 28 days before starting study treatment. Following the screening visit, participants will be admitted to a clinic for 4 days for treatment with either the study drug or placebo. They will attend a follow-up visit on Days 5 and 7 and participate in a follow-up phone call on Day 8. Three different doses will be tested to find the highest safe dose.
Detailed description
A Single ascending dose (SAD) will be administered to evaluate safety, tolerability and pharmacokinetics (PK) of MCAM.
MCAM will be dosed orally to healthy adult participants at one of 3 dose levels: 3, 10, or 30 mg or a matching placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A phase 1, first-in-human, placebo-controlled study. A dose escalation to determine maximum tolerable dose.
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Group (SAD) MCAM | Experimental | Drug: MCAMMCAM will be dosed orally using 3 dose levels: 3, 10 and 30 mg free base on Day 1. |
| Single Ascending Group Placebo | Placebo comparator | Other: PlaceboParticipants randomized to placebo will receive 1% methylcellulose solution on Day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Is willing and able to provide informed consent and comply with all protocol requirements
- Is aged ≥18 years and ≤55 years at time of informed consent
- Has a body mass index (BMI) between 18.0 and 32.0 kg/m2 and body weight (BW) not lower than 50 kg
- Participant is a nonsmoker (for at least 3 months prior to Screening) and does not use tobacco-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, or nicotine patch or gum)
- Has Blood pressure (BP) and Heart rate (HR) within the normal range at the Screening visit after 5 minutes in a seated position:
Key exclusion criteria (19 listed)
- Any significant acute or chronic medical illness
- Any history of cancer within 5 years of enrollment, with the exception of fully resected skin basal cell carcinoma
- Any major hospitalization or surgery 3 months prior to study drug administration
- Has donated or experienced a blood loss of 500 mL or more within 56 days prior to Screening or has donated plasma within 7 days prior to Screening
- Poor venous access assessed at 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 |
|---|---|---|
| PlaceboAlso: methylcellulose solutionA 1% methylcellulose solution will be dosed orally using an amber syringe to maintain blinding. | Other | Single Ascending Group Placebo |
| MCAMMCAM will be dosed orally as a 3, 10, or 30 mg suspension in an amber syringe to maintain blinding. | Drug | Single Ascending Group (SAD) MCAM |
Primary outcome
Single Ascending Dose (SAD): Cmax
Time frame: Baseline to 96 hours
Maximum plasma concentration in the blood after administration
SAD: Tmax
Time frame: Baseline to 96 hours
Time to maximum concentration of drug in the blood
SAD: T1/2
Time frame: Baseline to 96 hours
Known as the "plasma half-life," this is the time required for the concentration of a substance (like a drug) in blood plasma to decrease by half its initial value.
SAD: Area under the curve from 0-24 hours
Time frame: Baseline to 96 hours
Area under the plasma concentration time curve from time 0 to 24 hours
SAD: Area under the curve from 0-t
Time frame: Baseline to 96 hours
Area under the plasma concentration time curve from time 0 to the last measurable concentration
SAD: Area under the curve from 0-infinity
Time frame: Baseline to 96 hours
Area Under the Curve from time zero to infinity (AUC 0-infinity) is a fundamental pharmacokinetic parameter representing the total drug exposure over time, from administration until the drug is completely eliminated. It measures the entire extent of absorption, distribution, metabolism, and excretion.
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 5 Oct 2026.
- Individual participant dataSharing planned: Yes. The results of the study will be used for the purposes of national and international registration, publication, and information for medical and pharmaceutical professionals.
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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.
Benjamin Sundling, DO principal investigator
Dr. Vince Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing MCAM in people with Opioid Use Disorder, run by The University of Texas Health Science Center at San Antonio 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 19 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 5 Oct 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Charles France, PhD (210 567 6969, france@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single Ascending Dose (SAD): Cmax (time frame: Baseline to 96 hours). The study lists 6 primary outcomes in all. 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 5 Oct 2026.