Study to Assess PDM608 in Healthy Adult Subjects

NCT05950906 | Completed Phase 1 Results FDA Drug

• 1 other identifier: CBR-PDM608-3001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (13)

• 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: BP

  Abnormal systolic and/or diastolic pressure (mmHg)

  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

Secondary Outcomes (1)

• To Assess Immunogenicity Following Single and Multiple Doses of PDM608

  Part 1: Day 1 through Day 22; Part 2: Day 1 through Day 60

Study Arms (4)

Part 1 SAD SC PDM608

EXPERIMENTAL

Single ascending dose, subcutaneous administration of PDM608

Drug: PDM608

Part 1 SAD SC Placebo

PLACEBO COMPARATOR

Single ascending dose, subcutaneous administration of matching placebo

Drug: Placebo

Part 2 MAD SC PDM608

EXPERIMENTAL

Multiple ascending dose, subcutaneous administration of PDM608 once weekly for 4 weeks.

Drug: PDM608

Part 2 MAD SC Placebo

PLACEBO COMPARATOR

Multiple ascending dose, subcutaneous administration of placebo once weekly for 4 weeks.

Drug: Placebo

Interventions

PDM608 DRUG

PDM608 subcutaneous at single or multiple dose(s) assigned by cohort

Part 1 SAD SC PDM608; Part 2 MAD SC PDM608

Placebo DRUG

Placebo subcutaneous at single or multiple dose(s) to match PDM608 administration.

Part 1 SAD SC Placebo; Part 2 MAD SC Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Quotient Sciences-Miami, Inc

Miami, Florida, 33126, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Calibr-Skaggs

abrooks@scripps.edu

(858) 242-1000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study; treatment assignment will not be known to the subjects, the Sponsor and staff involved in the clinical evaluation of the subjects and the analysis of data. The randomization schedule and disclosure envelopes will be generated by an unblinded statistician. The unblinded statistician will not be involved in decisions relating to populations for analysis prior to unblinding. Prior to database lock and unblinding, all original randomization materials including the original final signed and dated randomization schedule will be held by the Quality Assurance department at the study site. The Data Sciences department will not have access to the randomization schedule before database lock/unblinding. There may be instances where interim data has the potential to reveal treatment. In these cases, every effort will be made by the unblinded pharmacokinetic scientist to maintain blinding by appropriate presentation of data to the study team.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: July 18, 2023
• Study Start: June 27, 2023
• Primary Completion: March 17, 2024
• Study Completion: April 19, 2024
• Last Updated: November 18, 2025
• Results First Posted: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)