Parkinson DiseasePhase 1NCT05950906

Study to Assess PDM608 in Healthy Adult Subjects

A Phase 1 study testing PDM608 in people with Parkinson Disease, run by Calibr, a division of Scripps Research at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Parkinson Disease
What is being tested?: PDM608
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 64 participants
Where: 1 siteUnited States
Study dates: 27 Jun 2023to 19 Apr 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 18Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Quotient Sciences-Miami, Inc
Miami, Florida, 33126

Other trials in United States

About this study

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

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

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: Parkinson Disease
Being tested: PDM608, Placebo
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PDM608Drug
PDM608 subcutaneous at single or multiple dose(s) assigned by cohort
PlaceboDrug
Placebo subcutaneous at single or multiple dose(s) to match PDM608 administration.

Study groups in NCT05950906
Study group	Role	What they receive
Part 1 SAD SC PDM608	Experimental	Single ascending dose, subcutaneous administration of PDM608 Receives: Drug: PDM608
Part 1 SAD SC Placebo	Placebo comparator	Single ascending dose, subcutaneous administration of matching placebo Receives: Drug: Placebo
Part 2 MAD SC PDM608	Experimental	Multiple ascending dose, subcutaneous administration of PDM608 once weekly for 4 weeks. Receives: Drug: PDM608
Part 2 MAD SC Placebo	Placebo comparator	Multiple ascending dose, subcutaneous administration of placebo once weekly for 4 weeks. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jun 202319 Apr 2024

First posted18 Jul 2023
Study start27 Jun 2023
Primary completion17 Mar 2024
Study completion19 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05950906
Sponsor's protocol ID: CBR-PDM608-3001
Status last verified: Nov 2025
First submitted: 22 May 2023
Last updated: 18 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Two-Part Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of PDM608 in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT05950906
Acronym / sponsor ID: CBR-PDM608-3001
Conditions: Parkinson Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Calibr, a division of Scripps ResearchUniversity, hospital or other
Collaborators: Michael J. Fox Foundation for Parkinson's Research, Alzheimer's Drug Discovery Foundation
Study start: 27 Jun 2023 (actual)
Primary completion: 17 Mar 2024 (actual)
Study completion: 19 Apr 2024 (actual)
First posted: 18 Jul 2023 (actual)
Results: Posted 18 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
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.

Arm	Type	Receives
Part 1 SAD SC PDM608	Experimental	Drug: PDM608Single ascending dose, subcutaneous administration of PDM608
Part 1 SAD SC Placebo	Placebo comparator	Drug: PlaceboSingle ascending dose, subcutaneous administration of matching placebo
Part 2 MAD SC PDM608	Experimental	Drug: PDM608Multiple ascending dose, subcutaneous administration of PDM608 once weekly for 4 weeks.
Part 2 MAD SC Placebo	Placebo comparator	Drug: PlaceboMultiple ascending dose, subcutaneous administration of placebo once weekly for 4 weeks.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (18 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PDM608PDM608 subcutaneous at single or multiple dose(s) assigned by cohort	Drug	Part 1 SAD SC PDM608, Part 2 MAD SC PDM608
PlaceboPlacebo subcutaneous at single or multiple dose(s) to match PDM608 administration.	Drug	Part 1 SAD SC Placebo, Part 2 MAD SC Placebo

Primary outcome

Number of Participants With Adverse Events
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Assess PK Parameters for Single (Part 1) and Multiple (Part 2) SC Doses of PDM608 in Healthy Volunteers.
Time frame: 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.

1 secondary outcome

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

Results and safety

Results posted to the registry on 18 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1 SAD SC PDM608 Cohort 1	6	6
Part 1 SAD SC Placebo Cohort 1	2	2
Part 1 SAD SC PDM608 Cohort 2	6	6
Part 1 SAD SC Placebo Cohort 2	2	2
Part 1 SAD SC PDM608 Cohort 3	6	6
Part 1 SAD SC Placebo Cohort 3	2	2
Part 1 SAD SC PDM608 Cohort 4	6	6
Part 1 SAD SC Placebo Cohort 4	2	2
Part 1 SAD SC PDM608 Cohort 5	6	6
Part 1 SAD SC Placebo Cohort 5	2	2
Part 2 MAD SC PDM608 Cohort 1	9	9
Part 2 MAD SC Placebo Cohort 1	3	3
Part 2 MAD SC PDM608 Cohort 2	9	7
Part 2 MAD SC Placebo Cohort 2	3	3

Primary outcome: Number of Participants With Adverse Events

Time frame: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26. Count of participants. Unit: Participants

Measure	Part 1 SAD SC PDM608 Cohort 1 n = 6	Part 2 SAD SC Placebo Cohort 1 n = 2	Part 1 SAD SC PDM608 Cohort 2 n = 6	Part 1 SAD SC Placebo Cohort 2 n = 2	Part 1 SAD SC PDM608 Cohort 3 n = 6	Part 1 SAD SC Placebo Cohort 3 n = 2	Part 1 SAD SC PDM608 Cohort 4 n = 6	Part 1 SAD SC Placebo Cohort 4 n = 2	Part 1 SAD SC PDM608 Cohort 5 n = 6	Part 1 SAD SC Placebo Cohort 5 n = 2	Part 2 MAD SC PDM608 Cohort 1 n = 9	Part 2 MAD SC Placebo Cohort 1 n = 3	Part 2 MAD SC PDM608 Cohort 2 n = 7	Part 2 MAD SC Placebo Cohort 2 n = 3
Value	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Primary outcome: Number of Participants With Clinically Significant Abnormal Laboratory Test Results

Time frame: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26. Count of participants. Unit: Participants

Measure	Part 1 SAD SC PDM608 Cohort 1 n = 6	Part 1 SAD SC Placebo Cohort 1 n = 2	Part 1 SAD SC PDM608 Cohort 2 n = 6	Part SAD SC Placebo Cohort 2 n = 2	Part 1 SAD SC PDM608 Cohort 3 n = 6	Part SAD SC Placebo Cohort 3 n = 2	Part 1 SAD SC PDM608 Cohort 4 n = 6	Part 1 SAD SC Placebo Cohort 4 n = 2	Part 1 SAD PDM608 Cohort 5 n = 6	Part 1 SAD Placebo Cohort 5 n = 2	Part 2 MAD SC PDM608 Cohort 1 n = 9	Part 2 MAD SC Placebo Cohort 1 n = 3	Part 2 MAD SC PDM608 Cohort 2 n = 7	Part 2 MAD SC Placebo Cohort 2 n = 3
Value	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Primary outcome: Number of Participants With Abnormal Electrocardiogram Readings: QTcF

Time frame: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26. Count of participants. Unit: Participants

Measure	Part 1 SAD SC PDM608 Cohort 1 n = 6	Part 1 SAD SC Placebo Cohort 1 n = 2	Part 1 SAD SC PDM608 Cohort 2 n = 6	Part 1 SAD SC Placebo Cohort 2 n = 2	Part 1 SAD SC PDM608 Cohort 3 n = 6	Part 1 SAD SC Placebo Cohort 3 n = 2	Part 1 SAD SC PDM608 Cohort 4 n = 6	Part 1 SAD SC Placebo Cohort 4 n = 2	Part 1 SAD SC PDM608 Cohort 5 n = 6	Part 1 SAD SC Placebo Cohort 5 n = 2	Part 2 MAD SC PDM608 Cohort 1 n = 9	Part 2 MAD SC Placebo Cohort 1 n = 3	Part 2 MAD SC PDM608 Cohort 2 n = 7	Part 2 MAD SC PDM608 Placebo Cohort 2 n = 3
Value	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Primary outcome: Number of Participants With Abnormal Electrocardiogram Readings: VR

Time frame: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26. Count of participants. Unit: Participants

Measure	Part 1 SAD SC PDM608 Cohort 1 n = 6	Part 1 SAD SC Placebo Cohort 1 n = 2	Part 1 SAD SC PDM608 Cohort 2 n = 6	Part 1 SAD SC Placebo Cohort 2 n = 2	Part 1 SAD SC PDM608 Cohort 3 n = 6	Part 1 SAD SC Placebo Cohort 3 n = 2	Part 1 SAD SC PDM608 Cohort 4 n = 6	Part 1 SAD SC Placebo Cohort 4 n = 2	Part 1 SAD SC PDM608Cohort 5 n = 6	Part 1 SAD SC Placebo Cohort 5 n = 2	Part 2 MAD SC PDM608 Cohort 1 n = 9	Part 2 MAD SC Placebo Cohort 1 n = 3	Part 2 MAD SC PDM608 Cohort 2 n = 7	Part 2 MAD SC Placebo Cohort 2 n = 3
Value	0	0	0	0	0	0	0	0	0	0	0	0	0	0

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1 SAD SC PDM608 Cohort 1	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Part 1 SAD SC Placebo Cohort 1	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Part 1 SAD SC PDM608 Cohort 2	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Part 1 SAD SC Placebo Cohort 2	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Part 1 SAD SC PDM608 Cohort 3	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Part 1 SAD SC Placebo Cohort 3	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Part 1 SAD SC PDM608 Cohort 4	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Part 1 SAD SC Placebo Cohort 4	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Part 1 SAD SC PDM608 Cohort 5	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Part 1 SAD SC Placebo Cohort 5	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Part 2 MAD SC PDM608 Cohort 1	0 of 9 (0%)	9 of 9 (100%)	0 of 9
Part 2 MAD SC Placebo Cohort 1	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
Part 2 MAD SC PDM608 Cohort 2	0 of 9 (0%)	9 of 9 (100%)	0 of 9
Part 2 MAD SC Placebo Cohort 2	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PDM608 in people with Parkinson Disease, run by Calibr, a division of Scripps Research at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (time frame: Part 1: Day 1 through Day 5; Part 2: Day 1 through Day 26). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05950906.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.