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)

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.

Description

Eligibility

Age range

18–55 years

Sex

All

Healthy volunteers

Yes

Interventions

• Other
  Placebo

  A 1% methylcellulose solution will be dosed orally using an amber syringe to maintain blinding.

• Drug
  MCAM

  MCAM will be dosed orally as a 3, 10, or 30 mg suspension in an amber syringe to maintain blinding.

Location