Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJM347 in Healthy Male Caucasian and Japanese Subjects in the Fasted and Fed State

A First-in-Human, Randomised, Double Blind, Placebo Controlled, Single and Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJM347 in Healthy Male Caucasian and Japanese Subjects in the Fasted and Fed State

This study will be conducted to determine the safety and tolerability of single and multiple oral ascending doses of AJM347 in healthy male participants, and to assess the pharmacodynamic response following single and multiple oral ascending doses of AJM347 in the same population. This study will also aim to determine the single and multiple oral ascending dose pharmacokinetics of AJM347 and its metabolite in healthy male participants, and to determine the effect of food on the single and multiple oral dose pharmacokinetics of AJM347 and its metabolite in the same population.

Inclusion Criteria:

Main Inclusion Criteria for all participants:

• Participants will be male
• Participants will be in good health

Main Inclusion Criteria for Japanese participants:

• Be ≥20 to ≤45 years of age
• Have body mass index (BMI) ≥18.5 to ≤25.0 kilograms per meters squared (kg/m^2)
• Be Japanese

Main Inclusion Criteria for Caucasian participants:

• Be ≥18 to ≤45 years of age
• Have a BMI ≥18.5 to ≤30.0 kg/m^2
• Be Caucasian

Exclusion Criteria:

Main Exclusion Criteria for all participants:

Participants will be excluded from the study if they satisfy any of the following criteria at the Screening visit, unless otherwise stated.

• Participants who have donated or lost ≥200 milliliters (mL) blood within 1 month or ≥400 mL within 3 months prior to Check-in

• Participants who have an abnormality in heart rate, blood pressure, temperature, or respiration rate at Screening

• Participants who have:

  • a positive urine drugs of abuse screen;
  • a positive alcohol breath test

• Participants who have an abnormality in the 12-lead electrocardiogram (ECG) at Screening

• Participants who are still participating in another clinical study (eg, attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months prior to first dose administration

• Participants who have a significant history of drug allergy, as determined by the Investigator

• Participants who have any clinically significant abnormal physical examination finding

• Participants who:

  • are carriers of the hepatitis B surface antigen (HBsAg);
  • are carriers of the hepatitis C antibody;
  • have a positive result for the test for human immunodeficiency virus (HIV) antibodies

• Participants who, in the opinion of the Investigator, should not participate in this study