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

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT07602335
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Placebo — OTHER
    A 1% methylcellulose solution will be dosed orally using an amber syringe to maintain blinding.
  • MCAM — DRUG
    MCAM will be dosed orally as a 3, 10, or 30 mg suspension in an amber syringe to maintain blinding.

Study Details

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.

Key Dates

Start date
Aug 8, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Single Ascending Group (SAD) MCAM
    MCAM will be dosed orally using 3 dose levels: 3, 10 and 30 mg free base on Day 1.
  • Placebo Comparator: Single Ascending Group Placebo
    Participants randomized to placebo will receive 1% methylcellulose solution on Day 1.

Primary Outcome Measure

Single Ascending Dose (SAD): Cmax [ Time Frame: Baseline to 96 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dr. Vince Clinical ResearchOverland ParkKansas66212
Benjamin Sundling, DO
[email protected]
913-333-3000

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Dr. Vince Clinical Research· Overland Park, KS

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