Clinical Trial

Safety, Tolerability, and Pharmacokinetics of MCAM in Healthy Adult Participants

Not Yet Recruiting Early Phase 1
View on ClinicalTrials.gov →
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.
Protocol Amendment History 5 changes
critical Primary endpoint(s) modified 2026-06-12
notable Enrollment reduced: 39 -> 24 participants 2026-06-12
minor Trial arms changed: 3 -> 2 2026-06-12
notable Primary completion pushed: 2027-05-31 -> 2027-06-30 2026-06-12
minor Completion pushed: 2027-11-30 -> 2027-12-31 2026-06-12
Trial Details
NCT Number NCT07602335
Lead Sponsor The University of Texas Health Science Center at San Antonio
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions Opioid Use Disorder
Enrollment 24 participants
Start Date 2026-08-08
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-11