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 (in years)
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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