Safety, Tolerability, and Pharmacokinetics of MCAM in Healthy Adult Participants (NCT07602335) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Safety, Tolerability, and Pharmacokinetics of MCAM in Healthy Adult Participants
United States24 participantsStarted 2026-08-08
Plain-language 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.
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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Single Ascending Dose (SAD): Cmax
Timeframe: Baseline to 96 hours
2
SAD: Tmax
Timeframe: Baseline to 96 hours
3
SAD: T1/2
Timeframe: Baseline to 96 hours
4
SAD: Area under the curve from 0-24 hours
Timeframe: Baseline to 96 hours
5
SAD: Area under the curve from 0-t
Timeframe: Baseline to 96 hours
6
SAD: Area under the curve from 0-infinity
Timeframe: Baseline to 96 hours
Trial details
NCT IDNCT07602335
SponsorThe University of Texas Health Science Center at San Antonio
. 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
. 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