Study to Assess PDM608 in Healthy Adult Subjects

A Two-Part Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of PDM608 in Healthy Adult Subjects

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

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: PDM608; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Zon Wang; Phone Number: 425-739-5288; Email: zonwang@scripps.edu
• Study Contact Backup: Name: Alex Brooks; Phone Number: 858-242-1130; Email: abrooks@scripps.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33126
      • Recruiting
      • Quotient Sciences-Miami, Inc
      • Principal Investigator: Johnathan Levy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1 SAD SC PDM608; Single ascending dose, subcutaneous administration of PDM608	Drug: PDM608; PDM608 subcutaneous at single or multiple dose(s) assigned by cohort
Placebo Comparator: Part 1 SAD SC Placebo; Single ascending dose, subcutaneous administration of matching placebo	Drug: Placebo; Placebo subcutaneous at single or multiple dose(s) to match PDM608 administration.
Experimental: Part 2 MAD SC PDM608; Multiple ascending dose, subcutaneous administration of PDM608 once weekly for 4 weeks.	Drug: PDM608; PDM608 subcutaneous at single or multiple dose(s) assigned by cohort
Placebo Comparator: Part 2 MAD SC Placebo; Multiple ascending dose, subcutaneous administration of placebo once weekly for 4 weeks.	Drug: Placebo; Placebo subcutaneous at single or multiple dose(s) to match PDM608 administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events	Adverse events will be analyzed for severity and potential relationship to PDM608 to determine safety and tolerability of PDM608	Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
Number of participants with clinically significant abnormal laboratory test results	Results outside of laboratory defined normal ranges will be analyzed for clinical significance and used to determine safety and tolerability of PDM608	Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
Number of participants with abnormal electrocardiogram readings: QTcF	Abnormal QTcF interval	Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
Number of participants with abnormal electrocardiogram readings: VR	Abnormal ventricular rate	Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
Number of participants with abnormal electrocardiogram readings: PR interval	Abnormal PR interval	Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
Number of participants with abnormal electrocardiogram readings: QRS duration	Abnormal QRS duration	Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
Number of participants with abnormal electrocardiogram readings: QRS axis	Abnormal QRS axis	Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
Number of participants with abnormal vital signs: HR	Abnormal heart rate (beats/minute)	Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
Number of participants with abnormal vital signs: Temp	Abnormal body temperature (Celsius)	Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
Number of participants with abnormal vital signs: RR	Abnormal respiratory rate (breaths/minute)	Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
Number of participants with abnormal physical exams	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	Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
Assess PK parameters for single (Part 1) and multiple (Part 2) SC doses of PDM608 in healthy volunteers.	Analysis of PDM608 plasma concentration data will be performed using PK parameters.	Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
Number of participants with abnormal vital signs: BP	Abnormal systolic and/or diastolic pressure (mmHg)	Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess immunogenicity following single and multiple doses of PDM608	Incidence of ADA in blood	Part 1: Day 1 through Day 22; Part 2: Day 1 through Day 60

Collaborators and Investigators

• Sponsor: Calibr, a division of Scripps Research
• Collaborators: Alzheimer's Drug Discovery Foundation; Michael J. Fox Foundation for Parkinson's Research

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2023
• Primary Completion (Estimated): March 26, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: May 22, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: CBR-PDM608-3001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No