Study to Assess PDM608 in Healthy Adult Subjects

Sponsor

Calibr, a division of Scripps Research (Other)

Overall Status

Recruiting

CT.gov ID

NCT05950906

Collaborator

Michael J. Fox Foundation for Parkinson's Research (Other), Alzheimer's Drug Discovery Foundation (Other)

Enrollment

Location

Arms

10.1

Anticipated Duration (Months)

8.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Drug: PDM608 Drug: Placebo	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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 (Participant, Care Provider, 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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 27, 2023

Anticipated Primary Completion Date :

Mar 26, 2024

Anticipated Study Completion Date :

Apr 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1 SAD SC PDM608 Single ascending dose, subcutaneous administration of PDM608	Drug: PDM608 PDM608 subcutaneous at single or multiple dose(s) assigned by cohort
Placebo Comparator: Part 1 SAD SC Placebo Single ascending dose, subcutaneous administration of matching placebo	Drug: Placebo Placebo subcutaneous at single or multiple dose(s) to match PDM608 administration.
Experimental: Part 2 MAD SC PDM608 Multiple ascending dose, subcutaneous administration of PDM608 once weekly for 4 weeks.	Drug: PDM608 PDM608 subcutaneous at single or multiple dose(s) assigned by cohort
Placebo Comparator: Part 2 MAD SC Placebo Multiple ascending dose, subcutaneous administration of placebo once weekly for 4 weeks.	Drug: Placebo Placebo subcutaneous at single or multiple dose(s) to match PDM608 administration.

Outcome Measures

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Quotient Sciences-Miami, Inc	Miami	Florida	United States	33126

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Calibr, a division of Scripps Research

ClinicalTrials.gov Identifier:

NCT05950906

Other Study ID Numbers:

CBR-PDM608-3001

First Posted:

Jul 18, 2023

Last Update Posted:

Jul 19, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Jul 19, 2023