For Healthcare Professionals

Study to Assess PDM608 in Healthy Adult Subjects

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About the study

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of PDM608 in healthy adult subjects.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

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

EXCLUSION CRITERIA

Exclusion Criteria:

  1. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
  2. Significant allergy requiring treatment
  3. 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
  4. Have poor venous access that limits phlebotomy
  5. Evidence of current SARS-CoV-2 infection or exposure to confirmed infection within 10 days prior to the first dose of study drug
  6. Clinically significant abnormal clinical chemistry, hematology or urinalysis
  7. Hepatitis B, Hepatitis C, HIV, TB
  8. Renal impairment
  9. Pregnant or lactating women or men with pregnant or lactating partners
  10. Received any IMP in a clinical research study within 5 half-lives or within 30 days prior to first dose (whichever is longer)
  11. 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
  12. 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.
  13. Drug or alcohol abuse in the past 2 years
  14. 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)
  15. Positive alcohol urine test at screening or first admission
  16. Current and within the last six months-smokers, e-cigarettes and nicotine replacement users
  17. Donation of blood within 2 months or donation of plasma within 7 days prior to first dose of study medication
  18. Subjects who are, or are immediate family members of, a study site or Sponsor employee
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 425-739-5288Email iconEmail Study Center

Study Details


Contition

Parkinson Disease

Age

18 - 65

Phase

PHASE1

Participants Needed

88

Est. Completion Date

Apr 30, 2024

Treatment Type

INTERVENTIONAL


Sponsor

Calibr, a division of Scripps Research

ClinicalTrials.gov NCT Identifier

NCT05950906

Study Number

CBR-PDM608-3001

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