Clinical trial NCT05950906: Study to Assess PDM608 in Healthy Adult Subjects
Official title: A Two-Part Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of PDM608 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson Disease
Lead sponsor: Calibr, a division of Scripps Research
Sponsor class: OTHER
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
name: Alzheimer's Drug Discovery Foundation
First posted: 2023-07-18
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Part 1 Cohorts 1-5 will assess single ascending doses (SAD) of subcutaneous administration PDM608. Part 2 will assess multiple ascending doses (MAD) administrations given once weekly for 4 weeks in up to 4 cohorts of participants. The parts of the study are not required to be conducted entirely sequentially, provided that this is justified by PK and safety data obtained from completed cohorts. The first MAD cohort will not start until data are available from SAD Cohort 3 and dosing for each MAD cohort will not exceed the a dose level previously deemed safe in a SAD cohort.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
measure: Number of participants with clinically significant abnormal laboratory test results
timeFrame: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
measure: Number of participants with abnormal electrocardiogram readings: QTcF
timeFrame: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
measure: Number of participants with abnormal electrocardiogram readings: VR
timeFrame: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
measure: Number of participants with abnormal electrocardiogram readings: PR interval
timeFrame: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
measure: Number of participants with abnormal electrocardiogram readings: QRS duration
timeFrame: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
measure: Number of participants with abnormal electrocardiogram readings: QRS axis
timeFrame: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
measure: Number of participants with abnormal vital signs: BP
timeFrame: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
measure: Number of participants with abnormal vital signs: HR
timeFrame: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
measure: Number of participants with abnormal vital signs: Temp
timeFrame: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
measure: Number of participants with abnormal vital signs: RR
timeFrame: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
measure: Number of participants with abnormal physical exams
timeFrame: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
measure: Assess PK parameters for single (Part 1) and multiple (Part 2) SC doses of PDM608 in healthy volunteers.
timeFrame: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
Secondary outcomes:
measure: To assess immunogenicity following single and multiple doses of PDM608
timeFrame: Part 1: Day 1 through Day 22; Part 2: Day 1 through Day 60
Other outcomes:
Locations:
city: Miami
country: United States
facility: Quotient Sciences-Miami, Inc
state: Florida
Study officials:
References: