Study to Assess PDM608 in Healthy Adult Subjects
- Registration Number
- NCT05950906
- Lead Sponsor
- Calibr, a division of Scripps Research
- Brief Summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of PDM608 in healthy adult subjects.
- Detailed Description
This is a 2-part, single-center, first-in-human study of single ascending doses (SAD; Part 1) and multiple ascending doses (MAD; Part 2) of PDM608 in healthy adult subjects.
Part 1 is a double-blind, randomized, placebo-controlled assessment of subcutaneous (SC) SAD administrations of PDM608 across 5 cohorts of subjects. All SAD cohorts will follow a sentinel design. Following completion of each cohort, safety and tolerability data through 96 hours post-dose will be reviewed to determine whether to progress to the next dose level and the dose level for the next cohort.
Part 2 is a double-blind, randomized, placebo-controlled assessment of SC MAD administrations (once weekly for 4 weeks) of PDM608 across up to 4 cohorts of subjects. Following completion of each cohort the safety and tolerability data 96 hours post last dose will be reviewed to determine whether to progress to the next dose level and the dose level to be administered.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- 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
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- Significant allergy requiring treatment
- 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
- Have poor venous access that limits phlebotomy
- Evidence of current SARS-CoV-2 infection or exposure to confirmed infection within 10 days prior to the first dose of study drug
- Clinically significant abnormal clinical chemistry, hematology or urinalysis
- Hepatitis B, Hepatitis C, HIV, TB
- Renal impairment
- Pregnant or lactating women or men with pregnant or lactating partners
- 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
- 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
- Donation of blood within 2 months or donation of plasma within 7 days prior to first dose of study medication
- Subjects who are, or are immediate family members of, a study site or Sponsor employee
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1 SAD SC PDM608 PDM608 Single ascending dose, subcutaneous administration of PDM608 Part 1 SAD SC Placebo Placebo Single ascending dose, subcutaneous administration of matching placebo Part 2 MAD SC PDM608 PDM608 Multiple ascending dose, subcutaneous administration of PDM608 once weekly for 4 weeks. Part 2 MAD SC Placebo Placebo Multiple ascending dose, subcutaneous administration of placebo once weekly for 4 weeks.
- Primary Outcome Measures
Name Time Method Number of participants with abnormal electrocardiogram readings: VR Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 Abnormal ventricular rate
Number of participants with abnormal electrocardiogram readings: QRS duration Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 Abnormal QRS duration
Number of participants with abnormal electrocardiogram readings: QRS axis Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 Abnormal QRS axis
Number of participants with abnormal vital signs: BP Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 Abnormal systolic and/or diastolic pressure (mmHg)
Number of participants with abnormal vital signs: HR Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 Abnormal heart rate (beats/minute)
Number of participants with abnormal vital signs: Temp Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 Abnormal body temperature (Celsius)
Number of participants with abnormal vital signs: RR Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 Abnormal respiratory rate (breaths/minute)
Number of participants with abnormal physical exams Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 Physical exams will include evaluation of general appearance, head, neck, thyroid, eyes, ears, nose and throat, respiratory, cardiovascular, abdomen, dermatological, genitourinary, musculoskeletal and neurological systems
Assess PK parameters for single (Part 1) and multiple (Part 2) SC doses of PDM608 in healthy volunteers. Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 Analysis of PDM608 plasma concentration data will be performed using PK parameters.
Number of participants with adverse events Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 Adverse events will be analyzed for severity and potential relationship to PDM608 to determine safety and tolerability of PDM608
Number of participants with clinically significant abnormal laboratory test results Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 Results outside of laboratory defined normal ranges will be analyzed for clinical significance and used to determine safety and tolerability of PDM608
Number of participants with abnormal electrocardiogram readings: PR interval Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 Abnormal PR interval
Number of participants with abnormal electrocardiogram readings: QTcF Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 Abnormal QTcF interval
- Secondary Outcome Measures
Name Time Method To assess immunogenicity following single and multiple doses of PDM608 Part 1: Day 1 through Day 22; Part 2: Day 1 through Day 60 Incidence of ADA in blood
Trial Locations
- Locations (1)
Quotient Sciences-Miami, Inc
🇺🇸Miami, Florida, United States