SAD Study to Assess the Safety, Tolerability, PK, and In-Vivo Performance of AMT-126 in Healthy Male and Female Subjects

A Phase 1 Study in up to 2 Parts, to Assess the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of AMT-126 in the Fasted State (in Part 1) and to Evaluate the In Vivo Performance of an AMT-126 Oral Tablet Through Pharmacoscintigraphic Assessment in the Fed and Fasted State (in Optional Part 2) in Healthy Male and Female Subjects

PART 1 & 2 (Healthy Volunteers)

Inclusion criteria

• Healthy male subjects and female subjects of NOCBP.
• Between 18 and 55 years of age (Part 1) and 30 and 55 years of age (Part 2), inclusive.
• A body mass index of between 18.0 and 32.0 kg/m2, inclusive.
• Contraception requirements for male & female subjects.

Exclusion criteria

• Known hypersensitivity or allergy to AMT-126 or excipient contained in the drug formulation.
• Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including kidney panel, and urinalysis).
• Presence, or history of clinically significant disease which requires treatment, as judged by the investigator.
• Evidence of current SARS-CoV-2 or COVID infection.
• Women of child-bearing potential.