CompletedNCT05950906Updated Nov 18, 2025Results posted

Study to Assess PDM608 in Healthy Adult Subjects

A Phase 1 interventional study of PDM608 and Placebo in Parkinson Disease, sponsored by Calibr, a division of Scripps Research. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-18.

Sponsored by Calibr, a division of Scripps Research · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 64
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

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

Read the 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.

Conditions studied

Parkinson Disease

Browse trials for

Parkinson Disease 4,487

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.

This study's enrollment of 64 is above the median of 40 across 3,293 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Calibr, a division of Scripps Research is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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 design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 64 participants (actual)

Study arms

Experimental
Part 1 SAD SC PDM608
Single ascending dose, subcutaneous administration of PDM608
Drug: PDM608
Placebo comparator
Part 1 SAD SC Placebo
Single ascending dose, subcutaneous administration of matching placebo
Drug: Placebo
Experimental
Part 2 MAD SC PDM608
Multiple ascending dose, subcutaneous administration of PDM608 once weekly for 4 weeks.
Drug: PDM608
Placebo comparator
Part 2 MAD SC Placebo
Multiple ascending dose, subcutaneous administration of placebo once weekly for 4 weeks.
Drug: Placebo

Interventions

DrugPDM608
PDM608 subcutaneous at single or multiple dose(s) assigned by cohort
DrugPlacebo
Placebo subcutaneous at single or multiple dose(s) to match PDM608 administration.

What researchers measure

Primary outcomes

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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26

Secondary outcomes

To Assess Immunogenicity Following Single and Multiple Doses of PDM608
Incidence of ADA in blood
Time frame: Part 1: Day 1 through Day 22; Part 2: Day 1 through Day 60

Results

Posted Nov 18, 2025

Participant flow

Participant flow — Overall Study
Milestone	Part 1 SAD SC PDM608 Cohort 1	Part 1 SAD SC Placebo Cohort 1	Part 1 SAD SC PDM608 Cohort 2	Part 1 SAD SC Placebo Cohort 2	Part 1 SAD SC PDM608 Cohort 3	Part 1 SAD SC Placebo Cohort 3	Part 1 SAD SC PDM608 Cohort 4	Part 1 SAD SC Placebo Cohort 4	Part 1 SAD SC PDM608 Cohort 5	Part 1 SAD SC Placebo Cohort 5	Part 2 MAD SC PDM608 Cohort 1	Part 2 MAD SC Placebo Cohort 1	Part 2 MAD SC PDM608 Cohort 2	Part 2 MAD SC Placebo Cohort 2
Started	6	2	6	2	6	2	6	2	6	2	9	3	9	3
Completed	6	2	6	2	6	2	6	2	6	2	9	3	7	3
Not completed	0	0	0	0	0	0	0	0	0	0	0	0	2	0
Withdrew: Adverse event	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Withdrew: Physician decision	0	0	0	0	0	0	0	0	0	0	0	0	1	0

Outcome measures

PrimaryNumber of Participants With Adverse Events

Adverse events will be analyzed for severity and potential relationship to PDM608 to determine safety and tolerability of PDM608

Time frame:: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
Reported as:: Count of participants · Participants

Number of Participants With Adverse Events
Participants	Part 1 SAD SC PDM608 Cohort 1	Part 2 SAD SC Placebo Cohort 1	Part 1 SAD SC PDM608 Cohort 2	Part 1 SAD SC Placebo Cohort 2	Part 1 SAD SC PDM608 Cohort 3	Part 1 SAD SC Placebo Cohort 3	Part 1 SAD SC PDM608 Cohort 4	Part 1 SAD SC Placebo Cohort 4	Part 1 SAD SC PDM608 Cohort 5	Part 1 SAD SC Placebo Cohort 5	Part 2 MAD SC PDM608 Cohort 1	Part 2 MAD SC Placebo Cohort 1	Part 2 MAD SC PDM608 Cohort 2	Part 2 MAD SC Placebo Cohort 2
Number of Participants With Adverse Events	0	0	0	0	0	0	0	0	0	0	0	0	0	0

PrimaryNumber 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

Time frame:: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
Reported as:: Count of participants · Participants

Number of Participants With Clinically Significant Abnormal Laboratory Test Results
Participants	Part 1 SAD SC PDM608 Cohort 1	Part 1 SAD SC Placebo Cohort 1	Part 1 SAD SC PDM608 Cohort 2	Part SAD SC Placebo Cohort 2	Part 1 SAD SC PDM608 Cohort 3	Part SAD SC Placebo Cohort 3	Part 1 SAD SC PDM608 Cohort 4	Part 1 SAD SC Placebo Cohort 4	Part 1 SAD PDM608 Cohort 5	Part 1 SAD Placebo Cohort 5	Part 2 MAD SC PDM608 Cohort 1	Part 2 MAD SC Placebo Cohort 1	Part 2 MAD SC PDM608 Cohort 2	Part 2 MAD SC Placebo Cohort 2
Number of Participants With Clinically Significant Abnormal Laboratory Test Results	0	0	0	0	0	0	0	0	0	0	0	0	0	0

PrimaryNumber of Participants With Abnormal Electrocardiogram Readings: QTcF

Abnormal QTcF interval

Time frame:: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
Reported as:: Count of participants · Participants

Number of Participants With Abnormal Electrocardiogram Readings: QTcF
Participants	Part 1 SAD SC PDM608 Cohort 1	Part 1 SAD SC Placebo Cohort 1	Part 1 SAD SC PDM608 Cohort 2	Part 1 SAD SC Placebo Cohort 2	Part 1 SAD SC PDM608 Cohort 3	Part 1 SAD SC Placebo Cohort 3	Part 1 SAD SC PDM608 Cohort 4	Part 1 SAD SC Placebo Cohort 4	Part 1 SAD SC PDM608 Cohort 5	Part 1 SAD SC Placebo Cohort 5	Part 2 MAD SC PDM608 Cohort 1	Part 2 MAD SC Placebo Cohort 1	Part 2 MAD SC PDM608 Cohort 2	Part 2 MAD SC PDM608 Placebo Cohort 2
Number of Participants With Abnormal Electrocardiogram Readings: QTcF	0	0	0	0	0	0	0	0	0	0	0	0	0	0

PrimaryNumber of Participants With Abnormal Electrocardiogram Readings: VR

Abnormal ventricular rate

Time frame:: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
Reported as:: Count of participants · Participants

Number of Participants With Abnormal Electrocardiogram Readings: VR
Participants	Part 1 SAD SC PDM608 Cohort 1	Part 1 SAD SC Placebo Cohort 1	Part 1 SAD SC PDM608 Cohort 2	Part 1 SAD SC Placebo Cohort 2	Part 1 SAD SC PDM608 Cohort 3	Part 1 SAD SC Placebo Cohort 3	Part 1 SAD SC PDM608 Cohort 4	Part 1 SAD SC Placebo Cohort 4	Part 1 SAD SC PDM608Cohort 5	Part 1 SAD SC Placebo Cohort 5	Part 2 MAD SC PDM608 Cohort 1	Part 2 MAD SC Placebo Cohort 1	Part 2 MAD SC PDM608 Cohort 2	Part 2 MAD SC Placebo Cohort 2
Number of Participants With Abnormal Electrocardiogram Readings: VR	0	0	0	0	0	0	0	0	0	0	0	0	0	0

PrimaryNumber of Participants With Abnormal Electrocardiogram Readings: PR Interval

Abnormal PR interval

Time frame:: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
Reported as:: Count of participants · Participants

Number of Participants With Abnormal Electrocardiogram Readings: PR Interval
Participants	Part 1 SAD SC PDM608 Cohort 1	Part 1 SAD SC Placebo Cohort 1	Part 1 SAD SC PDM608 Cohort 2	Part 1 SAD SC Placebo Cohort 2	Part 1 SAD SC PDM608 Cohort 3	Part 1 SAD SC Placebo Cohort 3	Part 1 SAD SC PDM608 Cohort 4	Part 1 SAD SC Placebo Cohort 4	Part 1 SAD SC PDM608 Cohort 5	Part 1 SAD SC Placebo Cohort 5	Part 2 MAD SC PDM608 Cohort 1	Part 2 MAD SC Placebo Cohort 1	Part 2 MAD SC PDM608 Cohort 2	Part 2 MAD SC Placebo Cohort 2
Number of Participants With Abnormal Electrocardiogram Readings: PR Interval	0	0	0	0	0	0	0	0	0	0	0	0	0	0

PrimaryNumber of Participants With Abnormal Electrocardiogram Readings: QRS Duration

Abnormal QRS duration

Time frame:: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
Reported as:: Count of participants · Participants

Number of Participants With Abnormal Electrocardiogram Readings: QRS Duration
Participants	Part 1 SAD SC PDM608 Cohort 1	Part 1 SAD SC Placebo Cohort 1	Part 1 SAD SC PDM608 Cohort 2	Part 1 SAD SC Placebo Cohort 2	Part 1 SAD SC PDM608 Cohort 3	Part 1 SAD SC Placebo Cohort 3	Part 1 SAD SC PDM608 Cohort 4	Part 1 SAD SC Placebo Cohort 4	Part 1 SAD SC PDM608 Cohort 5	Part 1 SAD SC Placebo Cohort 5	Part 2 MAD SC PDM608 Cohort 1	Part 2 MAD SC Placebo Cohort 1	Part 2 MAD SC PDM608 Cohort 2	Part 2 MAD SC Placebo Cohort 2
Number of Participants With Abnormal Electrocardiogram Readings: QRS Duration	0	0	0	0	0	0	0	0	0	0	0	0	0	0

PrimaryNumber of Participants With Abnormal Electrocardiogram Readings: QRS Axis

Abnormal QRS axis

Time frame:: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
Reported as:: Count of participants · Participants

Number of Participants With Abnormal Electrocardiogram Readings: QRS Axis
Participants	Part 1 SAD SC PDM608 Cohort 1	Part 1 SAD SC Placebo Cohort 1	Part 1 SAD SC PDM608 Cohort 2	Part 1 SAD SC Placebo Cohort 2	Part 1 SAD SC PDM608 Cohort 3	Part 1 SAD SC Placebo Cohort 3	Part 1 SAD SC PDM608 Cohort 4	Part 1 SAD SC Placebo Cohort 4	Part 1 SAD SC PDM608 Cohort 5	Part 1 SAD SC Placebo Cohort 5	Part 2 MAD SC PDM608 Cohort 1	Part 2 MAD SC Placebo Cohort 1	Part 2 MAD SC PDM608 Cohort 2	Part 2 MAD SC Placebo Cohort 2
Number of Participants With Abnormal Electrocardiogram Readings: QRS Axis	0	0	0	0	0	0	0	0	0	0	0	0	0	0

PrimaryNumber of Participants With Abnormal Vital Signs: BP

Abnormal systolic and/or diastolic pressure (mmHg)

Time frame:: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
Reported as:: Count of participants · Participants

Number of Participants With Abnormal Vital Signs: BP
Participants	Part 1 SAD SC PDM608 Cohort 1	Part 1 SAD SC Placebo Cohort 1	Part 1 SAD SC PDM608 Cohort 2	Part 1 SAD SC Placebo Cohort 2	Part 1 SAD SC PDM608 Cohort 3	Part 1 SAD SC Placebo Cohort 3	Part 1 SAD SC PDM608 Cohort 4	Part 1 SAD SC Placebo Cohort 4	Part 1 SAD SC PDM608 Cohort 5	Part 1 SAD SC Placebo Cohort 5	Part 2 MAD SC PDM608 Cohort 1	Part 2 MAD SC Placebo Cohort 1	Part 2 MAD SC PDM608 Cohort 2	Part 2 MAD SC Placebo Cohort 2
Number of Participants With Abnormal Vital Signs: BP	0	0	0	0	0	0	0	0	0	0	0	0	0	0

PrimaryNumber of Participants With Abnormal Vital Signs: HR

Abnormal heart rate (beats/minute)

Time frame:: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
Reported as:: Count of participants · Participants

Number of Participants With Abnormal Vital Signs: HR
Participants	Part 1 SAD SC PDM608 Cohort 1	Part 1 SAD SC Placebo Cohort 1	Part 1 SAD SC PDM608 Cohort 2	Part 1 SAD SC Placebo Cohort 2	Part 1 SAD SC PDM608 Cohort 3	Part 1 SAD Placebo Cohort 3	Part 1 SAD SC PDM608 Cohort 4	Part 1 SAD SC Placebo Cohort 4	Part 1 SAD SC PDM608 Cohort 5	Part 1 SAD SC Placebo Cohort 5	Part 2 MAD SC PDM608 Cohort 1	Part 2 MAD SC Placebo Cohort 1	Part 2 MAD SC PDM608 Cohort 2	Part 2 MAD SC Placebo Cohort 2
Number of Participants With Abnormal Vital Signs: HR	0	0	0	0	0	0	0	0	0	0	0	0	0	0

PrimaryNumber of Participants With Abnormal Vital Signs: Temp

Abnormal body temperature (Celsius)

Time frame:: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
Reported as:: Count of participants · Participants

Number of Participants With Abnormal Vital Signs: Temp
Participants	Part 1 SAD SC PDM608 Cohort 1	Part 1 SAD SC Placebo Cohort 1	Part 1 SAD SC PDM608 Cohort 2	Part 1 SAD SC Placebo Cohort 2	Part 1 SAD SC PDM608 Cohort 3	Part 1 SAD SC Placebo Cohort 3	Part 1 SAD SC PDM608 Cohort 4	Part 1 SAD SC Placebo Cohort 4	Part 1 SAD SC PDM608 Cohort 5	Part 1 SAD SC Placebo Cohort 5	Part 2 MAD SC PDM608 Cohort 1	Part 2 MAD SC Placebo Cohort 1	Part 2 MAD SC PDM608 Cohort 2	Part 2 MAD SC Placebo Cohort 2
Number of Participants With Abnormal Vital Signs: Temp	0	0	0	0	0	0	0	0	0	0	0	0	0	0

PrimaryNumber of Participants With Abnormal Vital Signs: RR

Abnormal respiratory rate (breaths/minute)

Time frame:: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
Reported as:: Count of participants · Participants

Number of Participants With Abnormal Vital Signs: RR
Participants	Part 1 SAD SC PDM608 Cohort 1	Part 1 SAD SC Placebo Cohort 1	Part 1 SAD SC PDM608 Cohort 2	Part 1 SAD SC Placebo Cohort 2	Part 1 SAD SC PDM608 Cohort 3	Part 1 SAD SC Placebo Cohort 3	Part 1 SAD SC PDM608 Cohort 4	Part 1 SAD SC Placebo Cohort 4	Part 1 SAD SC PDM608 Cohort 5	Part 1 SAD SC Placebo Cohort 5	Part 2 MAD SC PDM608 Cohort 1	Part 2 MAD SC Placebo Cohort 1	Part 2 MAD SC PDM608 Cohort 2	Part 2 MAD SC Placebo Cohort 2
Number of Participants With Abnormal Vital Signs: RR	0	0	0	0	0	0	0	0	0	0	0	0	0	0

PrimaryNumber 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

Time frame:: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
Reported as:: Count of participants · Participants

Number of Participants With Abnormal Physical Exams
Participants	Part 1 SAD SC PDM608 Cohort 1	Part 1 SAD SC Placebo Cohort 1	Part 1 SAD SC PDM608 Cohort 2	Part 1 SAD SC Placebo Cohort 2	Part 1 SAD SC PDM608 Cohort 3	Part 1 SAD SC Placebo Cohort 3	Part 1 SAD SC PDM608 Cohort 4	Part 1 SAD SC Placebo Cohort 4	Part 1 SAD SC PDM608 Cohort 5	Part 1 SAD SC Placebo Cohort 5	Part 2 MAD SC PDM608 Cohort 1	Part 2 MAD SC Placebo Cohort 1	Part 2 MAD SC PDM608 Cohort 2	Part 2 MAD SC Placebo Cohort 2
Number of Participants With Abnormal Physical Exams	0	0	0	0	0	0	0	0	0	0	0	0	0	0

PrimaryAssess 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.

Time frame:: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
Reported as:: Geometric mean · ng/mL

Assess PK Parameters for Single (Part 1) and Multiple (Part 2) SC Doses of PDM608 in Healthy Volunteers.
ng/mL	Part 1 SAD SC PDM608 Cohort 1	Part 1 SAD SC PDM608 Cohort 2	Part 1 SAD SC PDM608 Cohort 3	Part 1 SAD SC PDM608 Cohort 4	Part 1 SAD SC PDM608 Cohort 5	Part 2 MAD SC PDM608 Cohort 1 Day 1	Part 2 MAD SC PDM608 Cohort 1 Day 22	Part 2 MAD SC PDM608 Cohort 2 Day 1	Part 2 MAD S CPDM608 Cohort 2 Day 22
Assess PK Parameters for Single (Part 1) and Multiple (Part 2) SC Doses of PDM608 in Healthy Volunteers.	NA ± NA	NA ± NA	23.4 ± 52.2	52.4 ± 96.4	203 ± 70.5	44.2 ± 60.2	21.9 ± 247.9	150 ± 0	10.7 ± 0

SecondaryTo Assess Immunogenicity Following Single and Multiple Doses of PDM608

Incidence of ADA in blood

Time frame:: Part 1: Day 1 through Day 22; Part 2: Day 1 through Day 60
Reported as:: Number · participants

To Assess Immunogenicity Following Single and Multiple Doses of PDM608
participants	Part 1 SAD SC PDM608 Cohort 1	Part 1 SAD SC PDM608 Cohort 2	Part 1 SAD SC PDM608 Cohort 3	Part 1 SC PDM608 Cohort 4	Part 1 SAD SC PDM608 Cohort 5	Part 2 MAD SC PDM608 Cohort 1	Part 2 MAD SC PDM608 Cohort 2
336 hours post-dose	4	6	5	5	6	—	—
504 hours post-dose	4	5	5	6	6	—	—
Day 28 (144 hours post-dose)	—	—	—	—	—	9	7
Day 60 (912 hours post-dose)	—	—	—	—	—	7	7

Adverse events

Collected over 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.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Part 1 SAD SC PDM608 Cohort 1	0/6 (0%)	0/6 (0%)	5/6 (83.3%)
Part 1 SAD SC Placebo Cohort 1	0/2 (0%)	0/2 (0%)	0/2 (0%)
Part 1 SAD SC PDM608 Cohort 2	0/6 (0%)	0/6 (0%)	5/6 (83.3%)
Part 1 SAD SC Placebo Cohort 2	0/2 (0%)	0/2 (0%)	1/2 (50%)
Part 1 SAD SC PDM608 Cohort 3	0/6 (0%)	0/6 (0%)	4/6 (66.7%)
Part 1 SAD SC Placebo Cohort 3	0/2 (0%)	0/2 (0%)	0/2 (0%)
Part 1 SAD SC PDM608 Cohort 4	0/6 (0%)	0/6 (0%)	6/6 (100%)
Part 1 SAD SC Placebo Cohort 4	0/2 (0%)	0/2 (0%)	0/2 (0%)
Part 1 SAD SC PDM608 Cohort 5	0/6 (0%)	0/6 (0%)	6/6 (100%)
Part 1 SAD SC Placebo Cohort 5	0/2 (0%)	0/2 (0%)	0/2 (0%)
Part 2 MAD SC PDM608 Cohort 1	0/9 (0%)	0/9 (0%)	9/9 (100%)
Part 2 MAD SC Placebo Cohort 1	0/3 (0%)	0/3 (0%)	2/3 (66.7%)
Part 2 MAD SC PDM608 Cohort 2	0/9 (0%)	0/9 (0%)	9/9 (100%)
Part 2 MAD SC Placebo Cohort 2	0/3 (0%)	0/3 (0%)	2/3 (66.7%)

Most frequent other events

Most frequent other events
Event	Part 1 SAD SC PDM608 Cohort 1	Part 1 SAD SC Placebo Cohort 1	Part 1 SAD SC PDM608 Cohort 2	Part 1 SAD SC Placebo Cohort 2	Part 1 SAD SC PDM608 Cohort 3	Part 1 SAD SC Placebo Cohort 3	Part 1 SAD SC PDM608 Cohort 4	Part 1 SAD SC Placebo Cohort 4	Part 1 SAD SC PDM608 Cohort 5	Part 1 SAD SC Placebo Cohort 5	Part 2 MAD SC PDM608 Cohort 1	Part 2 MAD SC Placebo Cohort 1	Part 2 MAD SC PDM608 Cohort 2	Part 2 MAD SC Placebo Cohort 2
Injection Site ReactionsSkin and subcutaneous tissue disorders	5/6	0/2	5/6	1/2	4/6	0/2	6/6	0/2	6/6	0/2	9/9	2/3	9/9	2/3

Baseline characteristics

Two subjects from MAD Cohort 2 (both assigned to receive PDM608) did not complete the study and are excluded.

Age, Categorical
Age, Categorical(Participants)	Part 1 SAD SC PDM608 Cohort 1	Part 1 SAD SC PDM608/Placebo Cohort 1	Part 1 SAD SC PDM608 Cohort 2	Part 1 SAD SC Placebo Cohort 2	Part 1 SAD SC PDM608Cohort 3	Part 1 SAD SC Placebo Cohort 3	Part 1 SAD SC PDM608 Cohort 4	Part 1 SAD SC Placebo Cohort 4	Part 1 SAD SC PDM608 Cohort 5	Part 1 SAD SC Placebo Cohort 5	Part 2 MAD SC PDM608 Cohort 1	Part 2 MAD SC Placebo Cohort 1	Part 2 MAD SC PDM608 Cohort 2	Part 2 MAD SC Placebo Cohort 2	Total
<=18 years	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Between 18 and 65 years	6	2	6	2	6	2	6	2	6	2	9	3	7	3	62
>=65 years	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	Part 1 SAD SC PDM608 Cohort 1	Part 1 SAD SC PDM608/Placebo Cohort 1	Part 1 SAD SC PDM608 Cohort 2	Part 1 SAD SC Placebo Cohort 2	Part 1 SAD SC PDM608Cohort 3	Part 1 SAD SC Placebo Cohort 3	Part 1 SAD SC PDM608 Cohort 4	Part 1 SAD SC Placebo Cohort 4	Part 1 SAD SC PDM608 Cohort 5	Part 1 SAD SC Placebo Cohort 5	Part 2 MAD SC PDM608 Cohort 1	Part 2 MAD SC Placebo Cohort 1	Part 2 MAD SC PDM608 Cohort 2	Part 2 MAD SC Placebo Cohort 2	Total
Female	2	0	1	1	1	1	2	1	1	0	2	1	1	1	15
Male	4	2	5	1	5	1	4	1	5	2	7	2	6	2	47

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Part 1 SAD SC PDM608 Cohort 1	Part 1 SAD SC PDM608/Placebo Cohort 1	Part 1 SAD SC PDM608 Cohort 2	Part 1 SAD SC Placebo Cohort 2	Part 1 SAD SC PDM608Cohort 3	Part 1 SAD SC Placebo Cohort 3	Part 1 SAD SC PDM608 Cohort 4	Part 1 SAD SC Placebo Cohort 4	Part 1 SAD SC PDM608 Cohort 5	Part 1 SAD SC Placebo Cohort 5	Part 2 MAD SC PDM608 Cohort 1	Part 2 MAD SC Placebo Cohort 1	Part 2 MAD SC PDM608 Cohort 2	Part 2 MAD SC Placebo Cohort 2	Total
Hispanic or Latino	6	2	6	2	6	2	6	2	6	2	9	3	7	3	62
Not Hispanic or Latino	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Part 1 SAD SC PDM608 Cohort 1	Part 1 SAD SC PDM608/Placebo Cohort 1	Part 1 SAD SC PDM608 Cohort 2	Part 1 SAD SC Placebo Cohort 2	Part 1 SAD SC PDM608Cohort 3	Part 1 SAD SC Placebo Cohort 3	Part 1 SAD SC PDM608 Cohort 4	Part 1 SAD SC Placebo Cohort 4	Part 1 SAD SC PDM608 Cohort 5	Part 1 SAD SC Placebo Cohort 5	Part 2 MAD SC PDM608 Cohort 1	Part 2 MAD SC Placebo Cohort 1	Part 2 MAD SC PDM608 Cohort 2	Part 2 MAD SC Placebo Cohort 2	Total
American Indian or Alaska Native	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Asian	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Black or African American	1	0	0	0	1	0	2	1	2	0	1	0	0	1	9
White	5	2	6	2	5	2	4	1	4	2	8	3	7	2	53
More than one race	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Study locations

1 site

Quotient Sciences-Miami, Inc
Miami, Florida 33126, United States

References and documents

Study documents

Protocol and statistical analysis plan · Jan 30, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05950906
Lead sponsor: Calibr, a division of Scripps Research
Collaborators: Michael J. Fox Foundation for Parkinson's Research, Alzheimer's Drug Discovery Foundation
Responsible party: Sponsor
First posted: Jul 18, 2023
Start date: Jun 27, 2023
Primary completion: Mar 17, 2024
Completion: Apr 19, 2024
Results posted: Nov 18, 2025
Last update: Nov 18, 2025

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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