Parkinson Disease
Conditions
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.
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.
Sponsors
Michael J. Fox Foundation for Parkinson's Research
Alzheimer's Drug Discovery Foundation
Calibr, a division of Scripps Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess PK Parameters for Single (Part 1) and Multiple (Part 2) SC Doses of PDM608 in Healthy Volunteers. | Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 | Analysis of PDM608 plasma concentration data will be performed using PK parameters. |
| Number of Participants With Adverse Events | Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 | Adverse events will be analyzed for severity and potential relationship to PDM608 to determine safety and tolerability of PDM608 |
| Number of Participants With Clinically Significant Abnormal Laboratory Test Results | Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 | Results outside of laboratory defined normal ranges will be analyzed for clinical significance and used to determine safety and tolerability of PDM608 |
| Number of Participants With Abnormal Electrocardiogram Readings: QTcF | Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 | Abnormal QTcF interval |
| Number of Participants With Abnormal Electrocardiogram Readings: VR | Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 | Abnormal ventricular rate |
| Number of Participants With Abnormal Electrocardiogram Readings: PR Interval | Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 | Abnormal PR interval |
| Number of Participants With Abnormal Electrocardiogram Readings: QRS Duration | Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 | Abnormal QRS duration |
| Number of Participants With Abnormal Electrocardiogram Readings: QRS Axis | Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 | Abnormal QRS axis |
| Number of Participants With Abnormal Vital Signs: BP | Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 | Abnormal systolic and/or diastolic pressure (mmHg) |
| Number of Participants With Abnormal Vital Signs: HR | Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 | Abnormal heart rate (beats/minute) |
| Number of Participants With Abnormal Vital Signs: Temp | Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 | Abnormal body temperature (Celsius) |
| Number of Participants With Abnormal Vital Signs: RR | Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 | Abnormal respiratory rate (breaths/minute) |
| Number of Participants With Abnormal Physical Exams | Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Assess Immunogenicity Following Single and Multiple Doses of PDM608 | Part 1: Day 1 through Day 22; Part 2: Day 1 through Day 60 | Incidence of ADA in blood |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Part 1 SAD SC PDM608 Cohort 1 Single SC administration dose of 350 ug PDM608 | 6 |
| Part 1 SAD SC PDM608/Placebo Cohort 1 Single SC administration dose of 350 ug Placebo | 2 |
| Part 1 SAD SC PDM608 Cohort 2 Single SC administration dose of 1050 ug PDM608 | 6 |
| Part 1 SAD SC Placebo Cohort 2 Single SC administration dose of 1050 ug Placebo | 2 |
| Part 1 SAD SC PDM608Cohort 3 Single SC administration dose of 3150 ug PDM608 | 6 |
| Part 1 SAD SC Placebo Cohort 3 Single SC administration dose of 3150 ug Placebo | 2 |
| Part 1 SAD SC PDM608 Cohort 4 Single SC administration dose of 6300 ug PDM608 | 6 |
| Part 1 SAD SC Placebo Cohort 4 Single SC administration dose of 6300 ug Placebo | 2 |
| Part 1 SAD SC PDM608 Cohort 5 Single SC administration dose of 12600 ug PDM608 | 6 |
| Part 1 SAD SC Placebo Cohort 5 Single SC administration dose of 12600 ug Placebo | 2 |
| Part 2 MAD SC PDM608 Cohort 1 Once a week subcutaneous administration of 6300 ug of PDM608 for 4 weeks | 9 |
| Part 2 MAD SC Placebo Cohort 1 Once a week subcutaneous administration of 6300 ug of Placebo for 4 weeks | 3 |
| Part 2 MAD SC PDM608 Cohort 2 Once a week subcutaneous administration of 12600 ug of PDM608 for 4 weeks | 7 |
| Part 2 MAD SC Placebo Cohort 2 Once a week subcutaneous administration of 12600 ug of Placebo for 4 weeks | 3 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | 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 PDM608 Cohort 1 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 62 Participants | 2 Participants | 6 Participants | 2 Participants | 6 Participants | 6 Participants | 2 Participants | 6 Participants | 2 Participants | 6 Participants | 2 Participants | 9 Participants | 3 Participants | 7 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 62 Participants | 2 Participants | 6 Participants | 2 Participants | 6 Participants | 6 Participants | 2 Participants | 6 Participants | 2 Participants | 6 Participants | 2 Participants | 9 Participants | 3 Participants | 7 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 53 Participants | 2 Participants | 6 Participants | 2 Participants | 5 Participants | 5 Participants | 2 Participants | 4 Participants | 1 Participants | 4 Participants | 2 Participants | 8 Participants | 3 Participants | 7 Participants | 2 Participants |
| Sex: Female, Male Female | 15 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 47 Participants | 2 Participants | 5 Participants | 1 Participants | 4 Participants | 5 Participants | 1 Participants | 4 Participants | 1 Participants | 5 Participants | 2 Participants | 7 Participants | 2 Participants | 6 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 2 | 0 / 6 | 0 / 2 | 0 / 6 | 0 / 2 | 0 / 6 | 0 / 2 | 0 / 6 | 0 / 2 | 0 / 9 | 0 / 3 | 0 / 9 | 0 / 3 |
| other Total, other adverse events | 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 |
| serious Total, serious adverse events | 0 / 6 | 0 / 2 | 0 / 6 | 0 / 2 | 0 / 6 | 0 / 2 | 0 / 6 | 0 / 2 | 0 / 6 | 0 / 2 | 0 / 9 | 0 / 3 | 0 / 9 | 0 / 3 |
Outcome results
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.
Time frame: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 SAD SC PDM608 Cohort 1 | Assess PK Parameters for Single (Part 1) and Multiple (Part 2) SC Doses of PDM608 in Healthy Volunteers. | NA ng/mL | — |
| Part 2 SAD SC Placebo Cohort 1 | Assess PK Parameters for Single (Part 1) and Multiple (Part 2) SC Doses of PDM608 in Healthy Volunteers. | NA ng/mL | — |
| Part 1 SAD SC PDM608 Cohort 2 | Assess PK Parameters for Single (Part 1) and Multiple (Part 2) SC Doses of PDM608 in Healthy Volunteers. | 23.4 ng/mL | Geometric Coefficient of Variation 52.2 |
| Part 1 SAD SC Placebo Cohort 2 | Assess PK Parameters for Single (Part 1) and Multiple (Part 2) SC Doses of PDM608 in Healthy Volunteers. | 52.4 ng/mL | Geometric Coefficient of Variation 96.4 |
| Part 1 SAD SC PDM608 Cohort 3 | Assess PK Parameters for Single (Part 1) and Multiple (Part 2) SC Doses of PDM608 in Healthy Volunteers. | 203 ng/mL | Geometric Coefficient of Variation 70.5 |
| Part 1 SAD SC Placebo Cohort 3 | Assess PK Parameters for Single (Part 1) and Multiple (Part 2) SC Doses of PDM608 in Healthy Volunteers. | 44.2 ng/mL | Geometric Coefficient of Variation 60.2 |
| Part 1 SAD SC PDM608 Cohort 4 | Assess PK Parameters for Single (Part 1) and Multiple (Part 2) SC Doses of PDM608 in Healthy Volunteers. | 21.9 ng/mL | Geometric Coefficient of Variation 247.9 |
| Part 1 SAD SC Placebo Cohort 4 | Assess PK Parameters for Single (Part 1) and Multiple (Part 2) SC Doses of PDM608 in Healthy Volunteers. | 150 ng/mL | Geometric Coefficient of Variation 0 |
| Part 1 SAD SC PDM608 Cohort 5 | Assess PK Parameters for Single (Part 1) and Multiple (Part 2) SC Doses of PDM608 in Healthy Volunteers. | 10.7 ng/mL | Geometric Coefficient of Variation 0 |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1 SAD SC PDM608 Cohort 1 | Number of Participants With Abnormal Electrocardiogram Readings: PR Interval | 0 Participants |
| Part 2 SAD SC Placebo Cohort 1 | Number of Participants With Abnormal Electrocardiogram Readings: PR Interval | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 2 | Number of Participants With Abnormal Electrocardiogram Readings: PR Interval | 0 Participants |
| Part 1 SAD SC Placebo Cohort 2 | Number of Participants With Abnormal Electrocardiogram Readings: PR Interval | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 3 | Number of Participants With Abnormal Electrocardiogram Readings: PR Interval | 0 Participants |
| Part 1 SAD SC Placebo Cohort 3 | Number of Participants With Abnormal Electrocardiogram Readings: PR Interval | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 4 | Number of Participants With Abnormal Electrocardiogram Readings: PR Interval | 0 Participants |
| Part 1 SAD SC Placebo Cohort 4 | Number of Participants With Abnormal Electrocardiogram Readings: PR Interval | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 5 | Number of Participants With Abnormal Electrocardiogram Readings: PR Interval | 0 Participants |
| Part 1 SAD SC Placebo Cohort 5 | Number of Participants With Abnormal Electrocardiogram Readings: PR Interval | 0 Participants |
| Part 2 MAD SC PDM608 Cohort 1 | Number of Participants With Abnormal Electrocardiogram Readings: PR Interval | 0 Participants |
| Part 2 MAD SC Placebo Cohort 1 | Number of Participants With Abnormal Electrocardiogram Readings: PR Interval | 0 Participants |
| Part 2 MAD SC PDM608 Cohort 2 | Number of Participants With Abnormal Electrocardiogram Readings: PR Interval | 0 Participants |
| Part 2 MAD SC Placebo Cohort 2 | Number of Participants With Abnormal Electrocardiogram Readings: PR Interval | 0 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1 SAD SC PDM608 Cohort 1 | Number of Participants With Abnormal Electrocardiogram Readings: QRS Axis | 0 Participants |
| Part 2 SAD SC Placebo Cohort 1 | Number of Participants With Abnormal Electrocardiogram Readings: QRS Axis | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 2 | Number of Participants With Abnormal Electrocardiogram Readings: QRS Axis | 0 Participants |
| Part 1 SAD SC Placebo Cohort 2 | Number of Participants With Abnormal Electrocardiogram Readings: QRS Axis | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 3 | Number of Participants With Abnormal Electrocardiogram Readings: QRS Axis | 0 Participants |
| Part 1 SAD SC Placebo Cohort 3 | Number of Participants With Abnormal Electrocardiogram Readings: QRS Axis | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 4 | Number of Participants With Abnormal Electrocardiogram Readings: QRS Axis | 0 Participants |
| Part 1 SAD SC Placebo Cohort 4 | Number of Participants With Abnormal Electrocardiogram Readings: QRS Axis | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 5 | Number of Participants With Abnormal Electrocardiogram Readings: QRS Axis | 0 Participants |
| Part 1 SAD SC Placebo Cohort 5 | Number of Participants With Abnormal Electrocardiogram Readings: QRS Axis | 0 Participants |
| Part 2 MAD SC PDM608 Cohort 1 | Number of Participants With Abnormal Electrocardiogram Readings: QRS Axis | 0 Participants |
| Part 2 MAD SC Placebo Cohort 1 | Number of Participants With Abnormal Electrocardiogram Readings: QRS Axis | 0 Participants |
| Part 2 MAD SC PDM608 Cohort 2 | Number of Participants With Abnormal Electrocardiogram Readings: QRS Axis | 0 Participants |
| Part 2 MAD SC Placebo Cohort 2 | Number of Participants With Abnormal Electrocardiogram Readings: QRS Axis | 0 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1 SAD SC PDM608 Cohort 1 | Number of Participants With Abnormal Electrocardiogram Readings: QRS Duration | 0 Participants |
| Part 2 SAD SC Placebo Cohort 1 | Number of Participants With Abnormal Electrocardiogram Readings: QRS Duration | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 2 | Number of Participants With Abnormal Electrocardiogram Readings: QRS Duration | 0 Participants |
| Part 1 SAD SC Placebo Cohort 2 | Number of Participants With Abnormal Electrocardiogram Readings: QRS Duration | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 3 | Number of Participants With Abnormal Electrocardiogram Readings: QRS Duration | 0 Participants |
| Part 1 SAD SC Placebo Cohort 3 | Number of Participants With Abnormal Electrocardiogram Readings: QRS Duration | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 4 | Number of Participants With Abnormal Electrocardiogram Readings: QRS Duration | 0 Participants |
| Part 1 SAD SC Placebo Cohort 4 | Number of Participants With Abnormal Electrocardiogram Readings: QRS Duration | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 5 | Number of Participants With Abnormal Electrocardiogram Readings: QRS Duration | 0 Participants |
| Part 1 SAD SC Placebo Cohort 5 | Number of Participants With Abnormal Electrocardiogram Readings: QRS Duration | 0 Participants |
| Part 2 MAD SC PDM608 Cohort 1 | Number of Participants With Abnormal Electrocardiogram Readings: QRS Duration | 0 Participants |
| Part 2 MAD SC Placebo Cohort 1 | Number of Participants With Abnormal Electrocardiogram Readings: QRS Duration | 0 Participants |
| Part 2 MAD SC PDM608 Cohort 2 | Number of Participants With Abnormal Electrocardiogram Readings: QRS Duration | 0 Participants |
| Part 2 MAD SC Placebo Cohort 2 | Number of Participants With Abnormal Electrocardiogram Readings: QRS Duration | 0 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1 SAD SC PDM608 Cohort 1 | Number of Participants With Abnormal Electrocardiogram Readings: QTcF | 0 Participants |
| Part 2 SAD SC Placebo Cohort 1 | Number of Participants With Abnormal Electrocardiogram Readings: QTcF | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 2 | Number of Participants With Abnormal Electrocardiogram Readings: QTcF | 0 Participants |
| Part 1 SAD SC Placebo Cohort 2 | Number of Participants With Abnormal Electrocardiogram Readings: QTcF | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 3 | Number of Participants With Abnormal Electrocardiogram Readings: QTcF | 0 Participants |
| Part 1 SAD SC Placebo Cohort 3 | Number of Participants With Abnormal Electrocardiogram Readings: QTcF | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 4 | Number of Participants With Abnormal Electrocardiogram Readings: QTcF | 0 Participants |
| Part 1 SAD SC Placebo Cohort 4 | Number of Participants With Abnormal Electrocardiogram Readings: QTcF | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 5 | Number of Participants With Abnormal Electrocardiogram Readings: QTcF | 0 Participants |
| Part 1 SAD SC Placebo Cohort 5 | Number of Participants With Abnormal Electrocardiogram Readings: QTcF | 0 Participants |
| Part 2 MAD SC PDM608 Cohort 1 | Number of Participants With Abnormal Electrocardiogram Readings: QTcF | 0 Participants |
| Part 2 MAD SC Placebo Cohort 1 | Number of Participants With Abnormal Electrocardiogram Readings: QTcF | 0 Participants |
| Part 2 MAD SC PDM608 Cohort 2 | Number of Participants With Abnormal Electrocardiogram Readings: QTcF | 0 Participants |
| Part 2 MAD SC Placebo Cohort 2 | Number of Participants With Abnormal Electrocardiogram Readings: QTcF | 0 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1 SAD SC PDM608 Cohort 1 | Number of Participants With Abnormal Electrocardiogram Readings: VR | 0 Participants |
| Part 2 SAD SC Placebo Cohort 1 | Number of Participants With Abnormal Electrocardiogram Readings: VR | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 2 | Number of Participants With Abnormal Electrocardiogram Readings: VR | 0 Participants |
| Part 1 SAD SC Placebo Cohort 2 | Number of Participants With Abnormal Electrocardiogram Readings: VR | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 3 | Number of Participants With Abnormal Electrocardiogram Readings: VR | 0 Participants |
| Part 1 SAD SC Placebo Cohort 3 | Number of Participants With Abnormal Electrocardiogram Readings: VR | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 4 | Number of Participants With Abnormal Electrocardiogram Readings: VR | 0 Participants |
| Part 1 SAD SC Placebo Cohort 4 | Number of Participants With Abnormal Electrocardiogram Readings: VR | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 5 | Number of Participants With Abnormal Electrocardiogram Readings: VR | 0 Participants |
| Part 1 SAD SC Placebo Cohort 5 | Number of Participants With Abnormal Electrocardiogram Readings: VR | 0 Participants |
| Part 2 MAD SC PDM608 Cohort 1 | Number of Participants With Abnormal Electrocardiogram Readings: VR | 0 Participants |
| Part 2 MAD SC Placebo Cohort 1 | Number of Participants With Abnormal Electrocardiogram Readings: VR | 0 Participants |
| Part 2 MAD SC PDM608 Cohort 2 | Number of Participants With Abnormal Electrocardiogram Readings: VR | 0 Participants |
| Part 2 MAD SC Placebo Cohort 2 | Number of Participants With Abnormal Electrocardiogram Readings: VR | 0 Participants |
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
Time frame: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1 SAD SC PDM608 Cohort 1 | Number of Participants With Abnormal Physical Exams | 0 Participants |
| Part 2 SAD SC Placebo Cohort 1 | Number of Participants With Abnormal Physical Exams | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 2 | Number of Participants With Abnormal Physical Exams | 0 Participants |
| Part 1 SAD SC Placebo Cohort 2 | Number of Participants With Abnormal Physical Exams | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 3 | Number of Participants With Abnormal Physical Exams | 0 Participants |
| Part 1 SAD SC Placebo Cohort 3 | Number of Participants With Abnormal Physical Exams | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 4 | Number of Participants With Abnormal Physical Exams | 0 Participants |
| Part 1 SAD SC Placebo Cohort 4 | Number of Participants With Abnormal Physical Exams | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 5 | Number of Participants With Abnormal Physical Exams | 0 Participants |
| Part 1 SAD SC Placebo Cohort 5 | Number of Participants With Abnormal Physical Exams | 0 Participants |
| Part 2 MAD SC PDM608 Cohort 1 | Number of Participants With Abnormal Physical Exams | 0 Participants |
| Part 2 MAD SC Placebo Cohort 1 | Number of Participants With Abnormal Physical Exams | 0 Participants |
| Part 2 MAD SC PDM608 Cohort 2 | Number of Participants With Abnormal Physical Exams | 0 Participants |
| Part 2 MAD SC Placebo Cohort 2 | Number of Participants With Abnormal Physical Exams | 0 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1 SAD SC PDM608 Cohort 1 | Number of Participants With Abnormal Vital Signs: BP | 0 Participants |
| Part 2 SAD SC Placebo Cohort 1 | Number of Participants With Abnormal Vital Signs: BP | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 2 | Number of Participants With Abnormal Vital Signs: BP | 0 Participants |
| Part 1 SAD SC Placebo Cohort 2 | Number of Participants With Abnormal Vital Signs: BP | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 3 | Number of Participants With Abnormal Vital Signs: BP | 0 Participants |
| Part 1 SAD SC Placebo Cohort 3 | Number of Participants With Abnormal Vital Signs: BP | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 4 | Number of Participants With Abnormal Vital Signs: BP | 0 Participants |
| Part 1 SAD SC Placebo Cohort 4 | Number of Participants With Abnormal Vital Signs: BP | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 5 | Number of Participants With Abnormal Vital Signs: BP | 0 Participants |
| Part 1 SAD SC Placebo Cohort 5 | Number of Participants With Abnormal Vital Signs: BP | 0 Participants |
| Part 2 MAD SC PDM608 Cohort 1 | Number of Participants With Abnormal Vital Signs: BP | 0 Participants |
| Part 2 MAD SC Placebo Cohort 1 | Number of Participants With Abnormal Vital Signs: BP | 0 Participants |
| Part 2 MAD SC PDM608 Cohort 2 | Number of Participants With Abnormal Vital Signs: BP | 0 Participants |
| Part 2 MAD SC Placebo Cohort 2 | Number of Participants With Abnormal Vital Signs: BP | 0 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1 SAD SC PDM608 Cohort 1 | Number of Participants With Abnormal Vital Signs: HR | 0 Participants |
| Part 2 SAD SC Placebo Cohort 1 | Number of Participants With Abnormal Vital Signs: HR | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 2 | Number of Participants With Abnormal Vital Signs: HR | 0 Participants |
| Part 1 SAD SC Placebo Cohort 2 | Number of Participants With Abnormal Vital Signs: HR | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 3 | Number of Participants With Abnormal Vital Signs: HR | 0 Participants |
| Part 1 SAD SC Placebo Cohort 3 | Number of Participants With Abnormal Vital Signs: HR | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 4 | Number of Participants With Abnormal Vital Signs: HR | 0 Participants |
| Part 1 SAD SC Placebo Cohort 4 | Number of Participants With Abnormal Vital Signs: HR | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 5 | Number of Participants With Abnormal Vital Signs: HR | 0 Participants |
| Part 1 SAD SC Placebo Cohort 5 | Number of Participants With Abnormal Vital Signs: HR | 0 Participants |
| Part 2 MAD SC PDM608 Cohort 1 | Number of Participants With Abnormal Vital Signs: HR | 0 Participants |
| Part 2 MAD SC Placebo Cohort 1 | Number of Participants With Abnormal Vital Signs: HR | 0 Participants |
| Part 2 MAD SC PDM608 Cohort 2 | Number of Participants With Abnormal Vital Signs: HR | 0 Participants |
| Part 2 MAD SC Placebo Cohort 2 | Number of Participants With Abnormal Vital Signs: HR | 0 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1 SAD SC PDM608 Cohort 1 | Number of Participants With Abnormal Vital Signs: RR | 0 Participants |
| Part 2 SAD SC Placebo Cohort 1 | Number of Participants With Abnormal Vital Signs: RR | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 2 | Number of Participants With Abnormal Vital Signs: RR | 0 Participants |
| Part 1 SAD SC Placebo Cohort 2 | Number of Participants With Abnormal Vital Signs: RR | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 3 | Number of Participants With Abnormal Vital Signs: RR | 0 Participants |
| Part 1 SAD SC Placebo Cohort 3 | Number of Participants With Abnormal Vital Signs: RR | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 4 | Number of Participants With Abnormal Vital Signs: RR | 0 Participants |
| Part 1 SAD SC Placebo Cohort 4 | Number of Participants With Abnormal Vital Signs: RR | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 5 | Number of Participants With Abnormal Vital Signs: RR | 0 Participants |
| Part 1 SAD SC Placebo Cohort 5 | Number of Participants With Abnormal Vital Signs: RR | 0 Participants |
| Part 2 MAD SC PDM608 Cohort 1 | Number of Participants With Abnormal Vital Signs: RR | 0 Participants |
| Part 2 MAD SC Placebo Cohort 1 | Number of Participants With Abnormal Vital Signs: RR | 0 Participants |
| Part 2 MAD SC PDM608 Cohort 2 | Number of Participants With Abnormal Vital Signs: RR | 0 Participants |
| Part 2 MAD SC Placebo Cohort 2 | Number of Participants With Abnormal Vital Signs: RR | 0 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1 SAD SC PDM608 Cohort 1 | Number of Participants With Abnormal Vital Signs: Temp | 0 Participants |
| Part 2 SAD SC Placebo Cohort 1 | Number of Participants With Abnormal Vital Signs: Temp | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 2 | Number of Participants With Abnormal Vital Signs: Temp | 0 Participants |
| Part 1 SAD SC Placebo Cohort 2 | Number of Participants With Abnormal Vital Signs: Temp | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 3 | Number of Participants With Abnormal Vital Signs: Temp | 0 Participants |
| Part 1 SAD SC Placebo Cohort 3 | Number of Participants With Abnormal Vital Signs: Temp | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 4 | Number of Participants With Abnormal Vital Signs: Temp | 0 Participants |
| Part 1 SAD SC Placebo Cohort 4 | Number of Participants With Abnormal Vital Signs: Temp | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 5 | Number of Participants With Abnormal Vital Signs: Temp | 0 Participants |
| Part 1 SAD SC Placebo Cohort 5 | Number of Participants With Abnormal Vital Signs: Temp | 0 Participants |
| Part 2 MAD SC PDM608 Cohort 1 | Number of Participants With Abnormal Vital Signs: Temp | 0 Participants |
| Part 2 MAD SC Placebo Cohort 1 | Number of Participants With Abnormal Vital Signs: Temp | 0 Participants |
| Part 2 MAD SC PDM608 Cohort 2 | Number of Participants With Abnormal Vital Signs: Temp | 0 Participants |
| Part 2 MAD SC Placebo Cohort 2 | Number of Participants With Abnormal Vital Signs: Temp | 0 Participants |
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
Time frame: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1 SAD SC PDM608 Cohort 1 | Number of Participants With Adverse Events | 0 Participants |
| Part 2 SAD SC Placebo Cohort 1 | Number of Participants With Adverse Events | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 2 | Number of Participants With Adverse Events | 0 Participants |
| Part 1 SAD SC Placebo Cohort 2 | Number of Participants With Adverse Events | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 3 | Number of Participants With Adverse Events | 0 Participants |
| Part 1 SAD SC Placebo Cohort 3 | Number of Participants With Adverse Events | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 4 | Number of Participants With Adverse Events | 0 Participants |
| Part 1 SAD SC Placebo Cohort 4 | Number of Participants With Adverse Events | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 5 | Number of Participants With Adverse Events | 0 Participants |
| Part 1 SAD SC Placebo Cohort 5 | Number of Participants With Adverse Events | 0 Participants |
| Part 2 MAD SC PDM608 Cohort 1 | Number of Participants With Adverse Events | 0 Participants |
| Part 2 MAD SC Placebo Cohort 1 | Number of Participants With Adverse Events | 0 Participants |
| Part 2 MAD SC PDM608 Cohort 2 | Number of Participants With Adverse Events | 0 Participants |
| Part 2 MAD SC Placebo Cohort 2 | Number of Participants With Adverse Events | 0 Participants |
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
Time frame: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1 SAD SC PDM608 Cohort 1 | Number of Participants With Clinically Significant Abnormal Laboratory Test Results | 0 Participants |
| Part 2 SAD SC Placebo Cohort 1 | Number of Participants With Clinically Significant Abnormal Laboratory Test Results | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 2 | Number of Participants With Clinically Significant Abnormal Laboratory Test Results | 0 Participants |
| Part 1 SAD SC Placebo Cohort 2 | Number of Participants With Clinically Significant Abnormal Laboratory Test Results | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 3 | Number of Participants With Clinically Significant Abnormal Laboratory Test Results | 0 Participants |
| Part 1 SAD SC Placebo Cohort 3 | Number of Participants With Clinically Significant Abnormal Laboratory Test Results | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 4 | Number of Participants With Clinically Significant Abnormal Laboratory Test Results | 0 Participants |
| Part 1 SAD SC Placebo Cohort 4 | Number of Participants With Clinically Significant Abnormal Laboratory Test Results | 0 Participants |
| Part 1 SAD SC PDM608 Cohort 5 | Number of Participants With Clinically Significant Abnormal Laboratory Test Results | 0 Participants |
| Part 1 SAD SC Placebo Cohort 5 | Number of Participants With Clinically Significant Abnormal Laboratory Test Results | 0 Participants |
| Part 2 MAD SC PDM608 Cohort 1 | Number of Participants With Clinically Significant Abnormal Laboratory Test Results | 0 Participants |
| Part 2 MAD SC Placebo Cohort 1 | Number of Participants With Clinically Significant Abnormal Laboratory Test Results | 0 Participants |
| Part 2 MAD SC PDM608 Cohort 2 | Number of Participants With Clinically Significant Abnormal Laboratory Test Results | 0 Participants |
| Part 2 MAD SC Placebo Cohort 2 | Number of Participants With Clinically Significant Abnormal Laboratory Test Results | 0 Participants |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 SAD SC PDM608 Cohort 1 | To Assess Immunogenicity Following Single and Multiple Doses of PDM608 | 336 hours post-dose | 4 participants |
| Part 1 SAD SC PDM608 Cohort 1 | To Assess Immunogenicity Following Single and Multiple Doses of PDM608 | 504 hours post-dose | 4 participants |
| Part 2 SAD SC Placebo Cohort 1 | To Assess Immunogenicity Following Single and Multiple Doses of PDM608 | 504 hours post-dose | 5 participants |
| Part 2 SAD SC Placebo Cohort 1 | To Assess Immunogenicity Following Single and Multiple Doses of PDM608 | 336 hours post-dose | 6 participants |
| Part 1 SAD SC PDM608 Cohort 2 | To Assess Immunogenicity Following Single and Multiple Doses of PDM608 | 504 hours post-dose | 5 participants |
| Part 1 SAD SC PDM608 Cohort 2 | To Assess Immunogenicity Following Single and Multiple Doses of PDM608 | 336 hours post-dose | 5 participants |
| Part 1 SAD SC Placebo Cohort 2 | To Assess Immunogenicity Following Single and Multiple Doses of PDM608 | 336 hours post-dose | 5 participants |
| Part 1 SAD SC Placebo Cohort 2 | To Assess Immunogenicity Following Single and Multiple Doses of PDM608 | 504 hours post-dose | 6 participants |
| Part 1 SAD SC PDM608 Cohort 3 | To Assess Immunogenicity Following Single and Multiple Doses of PDM608 | 336 hours post-dose | 6 participants |
| Part 1 SAD SC PDM608 Cohort 3 | To Assess Immunogenicity Following Single and Multiple Doses of PDM608 | 504 hours post-dose | 6 participants |
| Part 1 SAD SC Placebo Cohort 3 | To Assess Immunogenicity Following Single and Multiple Doses of PDM608 | Day 28 (144 hours post-dose) | 9 participants |
| Part 1 SAD SC Placebo Cohort 3 | To Assess Immunogenicity Following Single and Multiple Doses of PDM608 | Day 60 (912 hours post-dose) | 7 participants |
| Part 1 SAD SC PDM608 Cohort 4 | To Assess Immunogenicity Following Single and Multiple Doses of PDM608 | Day 28 (144 hours post-dose) | 7 participants |
| Part 1 SAD SC PDM608 Cohort 4 | To Assess Immunogenicity Following Single and Multiple Doses of PDM608 | Day 60 (912 hours post-dose) | 7 participants |