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| Name | Class |
|---|---|
| Michael J. Fox Foundation for Parkinson's Research | OTHER |
| Alzheimer's Drug Discovery Foundation | OTHER |
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The purpose of this study is to assess the safety, tolerability and pharmacokinetics of PDM608 in healthy adult subjects.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 SAD SC PDM608 | Experimental | Single ascending dose, subcutaneous administration of PDM608 |
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| Part 1 SAD SC Placebo | Placebo Comparator | Single ascending dose, subcutaneous administration of matching placebo |
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| Part 2 MAD SC PDM608 | Experimental | Multiple ascending dose, subcutaneous administration of PDM608 once weekly for 4 weeks. |
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| Part 2 MAD SC Placebo | Placebo Comparator | Multiple ascending dose, subcutaneous administration of placebo once weekly for 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PDM608 | Drug | PDM608 subcutaneous at single or multiple dose(s) assigned by cohort |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences-Miami, Inc | Miami | Florida | 33126 | United States |
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Participant enrollment was reported as a combined arm (reporting PDM608 and Placebo subjects) to in sections where there is no major benefit to differentiate between treatment vs placebo. Comments were added to Part 2 MAD SC Placebo Cohort 2 to denote that the two subjects who didn't complete the study were assigned to receive active treatment. For the PK and ADA, analysis was only done on subjects who received PDM608.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1 SAD SC PDM608 Cohort 1 | One time subcutaneous administration of 350 ug of PDM608. 6 subjects received PDM608 |
| FG001 | Part 1 SAD SC Placebo Cohort 1 | One time subcutaneous administration of 350 ug of PDM608. 2 subjects received Placebo. |
| FG002 | Part 1 SAD SC PDM608 Cohort 2 | One time subcutaneous administration of 1050 ug of PDM608. 2 subjects received Placebo. |
| FG003 | Part 1 SAD SC Placebo Cohort 2 | One time subcutaneous administration of 1050 ug of PDM608. 2 subjects received Placebo. |
| FG004 | Part 1 SAD SC PDM608 Cohort 3 | One time subcutaneous administration of 3150 ug of PDM608. 6 subjects received PDM608. |
| FG005 | Part 1 SAD SC Placebo Cohort 3 | One time subcutaneous administration of 3150 ug of PDM608. 2 subjects received Placebo. |
| FG006 | Part 1 SAD SC PDM608 Cohort 4 | One time subcutaneous administration of 6300 ug of PDM608. 6 subjects received PDM608. |
| FG007 | Part 1 SAD SC Placebo Cohort 4 | One time subcutaneous administration of 6300 ug of PDM608. 2 subjects received Placebo. |
| FG008 | Part 1 SAD SC PDM608 Cohort 5 | One time subcutaneous administration of 12600 ug of PDM608. 6 subjects received PDM60. |
| FG009 | Part 1 SAD SC Placebo Cohort 5 | One time subcutaneous administration of 12600 ug of PDM608. 2 subjects received Placebo. |
| FG010 | Part 2 MAD SC PDM608 Cohort 1 | Subcutaneous administration of 6300ug of PDM608/Placebo once weekly for 4 weeks. 9 subjects received PDM608 |
| FG011 | Part 2 MAD SC Placebo Cohort 1 | Subcutaneous administration of 6300ug of PDM608/Placebo once weekly for 4 weeks. 3 subjects received Placebo |
| FG012 | Part 2 MAD SC PDM608 Cohort 2 | Subcutaneous administration of 12600ug of PDM608/Placebo once weekly for 4 weeks. 9 subjects received PDM608 on week 1. 2 subjects were withdrawn per PI's discretion before receiving all 4 weekly doses of PDM608. |
| FG013 | Part 2 MAD SC Placebo Cohort 2 | Subcutaneous administration of 12600ug of PDM608/Placebo once weekly for 4 weeks. 3 subjects received Placeb |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Two subjects from MAD Cohort 2 (both assigned to receive PDM608) did not complete the study and are excluded.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1 SAD SC PDM608 Cohort 1 | Single SC administration dose of 350 ug PDM608 |
| BG001 | Part 1 SAD SC PDM608/Placebo Cohort 1 | Single SC administration dose of 350 ug Placebo |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 |
|
Adverse events was collected from the time of consent to 30 days after the last dose of study drug. For Part 1, duration of study participation is 22 days with PDM608/Placebo administered on Day 1. Study duration for Part 2 is 60 with the last dose of PDM608/Placebo administered on Day 22. If subjects have ongoing AEs at the end of study visit, the study team contacted the subjects weekly until AE resolution.
During each study visit, subjects were questioned directly regarding occurrence of any adverse medical event. All AEs were documented in the EDC, including date, time of onset, description of AE, severity, seriousness, duration, actions taken, outcome and an investigator's opinion on relationship between study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1 SAD SC PDM608 Cohort 1 | Single SC administration dose of 350 ug PDM608 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Reactions | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Calibr-Skaggs | (858) 242-1000 | abrooks@scripps.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2023 | Aug 6, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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.
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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.
| Placebo | Drug | Placebo subcutaneous at single or multiple dose(s) to match PDM608 administration. |
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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 |
| Physician Decision |
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| BG002 | Part 1 SAD SC PDM608 Cohort 2 | Single SC administration dose of 1050 ug PDM608 |
| BG003 | Part 1 SAD SC Placebo Cohort 2 | Single SC administration dose of 1050 ug Placebo |
| BG004 | Part 1 SAD SC PDM608Cohort 3 | Single SC administration dose of 3150 ug PDM608 |
| BG005 | Part 1 SAD SC Placebo Cohort 3 | Single SC administration dose of 3150 ug Placebo |
| BG006 | Part 1 SAD SC PDM608 Cohort 4 | Single SC administration dose of 6300 ug PDM608 |
| BG007 | Part 1 SAD SC Placebo Cohort 4 | Single SC administration dose of 6300 ug Placebo |
| BG008 | Part 1 SAD SC PDM608 Cohort 5 | Single SC administration dose of 12600 ug PDM608 |
| BG009 | Part 1 SAD SC Placebo Cohort 5 | Single SC administration dose of 12600 ug Placebo |
| BG010 | Part 2 MAD SC PDM608 Cohort 1 | Once a week subcutaneous administration of 6300 ug of PDM608 for 4 weeks |
| BG011 | Part 2 MAD SC Placebo Cohort 1 | Once a week subcutaneous administration of 6300 ug of Placebo for 4 weeks |
| BG012 | Part 2 MAD SC PDM608 Cohort 2 | Once a week subcutaneous administration of 12600 ug of PDM608 for 4 weeks |
| BG013 | Part 2 MAD SC Placebo Cohort 2 | Once a week subcutaneous administration of 12600 ug of Placebo for 4 weeks |
| BG014 | Total | Total of all reporting groups |
| Participants |
| No |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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Single SC administration dose of 1050 ug PDM608 |
| OG003 | Part 1 SAD SC Placebo Cohort 2 | Single SC administration dose of 1050 ug Placebo |
| OG004 | Part 1 SAD SC PDM608 Cohort 3 | Single SC administration dose of 3150 ug PDM608 |
| OG005 | Part 1 SAD SC Placebo Cohort 3 | Single SC administration dose of 3150 ug Placebo |
| OG006 | Part 1 SAD SC PDM608 Cohort 4 | Single SC administration dose of 6300 ug PDM608 |
| OG007 | Part 1 SAD SC Placebo Cohort 4 | Single SC administration dose of 6300 ug Placebo |
| OG008 | Part 1 SAD SC PDM608 Cohort 5 | Single SC administration dose of 12600 ug PDM608 |
| OG009 | Part 1 SAD SC Placebo Cohort 5 | Single SC administration dose of 12600 ug Placebo |
| OG010 | Part 2 MAD SC PDM608 Cohort 1 | Once a week subcutaneous administration of 6300 ug of PDM608 for 4 weeks |
| OG011 | Part 2 MAD SC Placebo Cohort 1 | Once a week subcutaneous administration of 6300 ug of Placebo for 4 weeks |
| OG012 | Part 2 MAD SC PDM608 Cohort 2 | Once a week subcutaneous administration of 12600 ug of PDM608 for 4 weeks 2 subjects withdrew from the study prior to receiving all 4 weekly doses of PDM608. |
| OG013 | Part 2 MAD SC Placebo Cohort 2 | Once a week subcutaneous administration of 12600 ug of Placebo for 4 weeks |
|
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| Primary | 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 | Posted | Count of Participants | Participants | Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 |
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| Primary | Number of Participants With Abnormal Electrocardiogram Readings: QTcF | Abnormal QTcF interval | Posted | Count of Participants | Participants | Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 |
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| Primary | Number of Participants With Abnormal Electrocardiogram Readings: VR | Abnormal ventricular rate | Posted | Count of Participants | Participants | Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 |
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| Primary | Number of Participants With Abnormal Electrocardiogram Readings: PR Interval | Abnormal PR interval | Posted | Count of Participants | Participants | Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 |
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| Primary | Number of Participants With Abnormal Electrocardiogram Readings: QRS Duration | Abnormal QRS duration | Posted | Count of Participants | Participants | Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 |
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| Primary | Number of Participants With Abnormal Electrocardiogram Readings: QRS Axis | Abnormal QRS axis | Posted | Count of Participants | Participants | Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 |
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| Primary | Number of Participants With Abnormal Vital Signs: BP | Abnormal systolic and/or diastolic pressure (mmHg) | Posted | Count of Participants | Participants | Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 |
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| Primary | Number of Participants With Abnormal Vital Signs: HR | Abnormal heart rate (beats/minute) | Posted | Count of Participants | Participants | Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 |
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| Primary | Number of Participants With Abnormal Vital Signs: Temp | Abnormal body temperature (Celsius) | Posted | Count of Participants | Participants | Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 |
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| Primary | Number of Participants With Abnormal Vital Signs: RR | Abnormal respiratory rate (breaths/minute) | Posted | Count of Participants | Participants | Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 |
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| Primary | 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 | Posted | Count of Participants | Participants | Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 |
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| Primary | 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. | Cmax for subjects dosed with PDM608 Following a single SC administration of PDM608 at dose levels of 350 μg (cohort 1) and 1050 μg (cohort 2), serum concentrations of PDM608 were BLQ (<10.0 ng/mL) for all subjects and time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 |
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| Secondary | To Assess Immunogenicity Following Single and Multiple Doses of PDM608 | Incidence of ADA in blood | The Number of Participants with Positive Anti-Drug Antibodies. Data was not collected for SAD cohorts for 144 and 912 hours pose dose. Data was not collected for MAD cohorts 1-2 for 336 and 504 hours post dose. | Posted | Number | participants | Part 1: Day 1 through Day 22; Part 2: Day 1 through Day 60 |
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| 0 |
| 6 |
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | Part 1 SAD SC Placebo Cohort 1 | Single SC administration dose of 350 ug Placebo | 0 | 2 | 0 | 2 | 0 | 2 |
| EG002 | Part 1 SAD SC PDM608 Cohort 2 | Single SC administration dose of 1050 ug PDM608 | 0 | 6 | 0 | 6 | 5 | 6 |
| EG003 | Part 1 SAD SC Placebo Cohort 2 | Single SC administration dose of 1050 ug Placebo | 0 | 2 | 0 | 2 | 1 | 2 |
| EG004 | Part 1 SAD SC PDM608 Cohort 3 | Single SC administration dose of 3150 ug PDM608 | 0 | 6 | 0 | 6 | 4 | 6 |
| EG005 | Part 1 SAD SC Placebo Cohort 3 | Single SC administration dose of 3150 ug Placebo | 0 | 2 | 0 | 2 | 0 | 2 |
| EG006 | Part 1 SAD SC PDM608 Cohort 4 | Single SC administration dose of 6300 ug PDM608 | 0 | 6 | 0 | 6 | 6 | 6 |
| EG007 | Part 1 SAD SC Placebo Cohort 4 | Single SC administration dose of 6300 ug Placebo | 0 | 2 | 0 | 2 | 0 | 2 |
| EG008 | Part 1 SAD SC PDM608 Cohort 5 | Single SC administration dose of 12600 ug PDM608 | 0 | 6 | 0 | 6 | 6 | 6 |
| EG009 | Part 1 SAD SC Placebo Cohort 5 | Single SC administration dose of 12600 ug Placebo | 0 | 2 | 0 | 2 | 0 | 2 |
| EG010 | Part 2 MAD SC PDM608 Cohort 1 | Once a week subcutaneous administration of 6300 ug of PDM608 for 4 weeks | 0 | 9 | 0 | 9 | 9 | 9 |
| EG011 | Part 2 MAD SC Placebo Cohort 1 | Once a week subcutaneous administration of 6300 ug of Placebo for 4 weeks | 0 | 3 | 0 | 3 | 2 | 3 |
| EG012 | Part 2 MAD SC PDM608 Cohort 2 | Once a week subcutaneous administration of 12600 ug of PDM608 for 4 weeks | 0 | 9 | 0 | 9 | 9 | 9 |
| EG013 | Part 2 MAD SC Placebo Cohort 2 | Once a week subcutaneous administration of 12600 ug of Placebo for 4 weeks | 0 | 3 | 0 | 3 | 2 | 3 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| 504 hours post-dose |
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| Day 28 (144 hours post-dose) |
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| Day 60 (912 hours post-dose) |
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