Study to Assess PDM608 in Healthy Adult Subjects

Korábbi kezelés

• History of clinically significant autoimmune, cardiovascular, renal, hepatic, chronic respiratory or GI disease (except cholecystectomy), neurological or psychiatric disorder, illness/infection/hospitalization or surgical procedure within 30 days prior to first dose of study drug or any uncontrolled medical illness as judged by the investigator
• Evidence of current SARS-CoV-2 infection or exposure to confirmed infection within 10 days prior to the first dose of study drug
• Received any IMP in a clinical research study within 5 half-lives or within 30 days prior to first dose (whichever is longer)
• Taking any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g per day acetaminophen and HRT) in the 14 days or 5 half-lives (whichever is longer) before IMP administration
• COVID-19 vaccine within 14 days prior to first dose or have a COVID-19 vaccine scheduled between their first dose of IMP and last dose of IMP.
• Drug or alcohol abuse in the past 2 years
• Donation of blood within 2 months or donation of plasma within 7 days prior to first dose of study medication

Más betegség

• Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
• Significant allergy requiring treatment
• Hepatitis B, Hepatitis C, HIV, TB
• Renal impairment

Egyéb

• Have poor venous access that limits phlebotomy
• Clinically significant abnormal clinical chemistry, hematology or urinalysis
• Pregnant or lactating women or men with pregnant or lactating partners
• Regular alcohol consumption in men >21 units per week and women >14 units per week (1 unit = 12 oz 1 bottle/can of beer, 1 oz 40% spirit or 5 oz glass of wine)
• Positive alcohol urine test at screening or first admission
• Current and within the last six months-smokers, e-cigarettes and nicotine replacement users
• Subjects who are, or are immediate family members of, a study site or Sponsor employee

• Healthy men, or women of non-childbearing potential
• Must agree to use an adequate method of contraception
• Body mass index (BMI) of 18.0 to 33.0 kg/m2 as measured at screening