Phase 1 N=64 Randomized Quadruple-blind Treatment

Study to Assess PDM608 in Healthy Adult Subjects

Parkinson Disease

Bottom Line

View on ClinicalTrials.gov: NCT05950906 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2025

Primary outcome: Primary: Number of Participants With Adverse Events — 0; 0; 0; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: PDM608 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Calibr, a division of Scripps Research
Primary completion: Mar 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Clinically Significant Abnormal Laboratory Test Results	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Abnormal Electrocardiogram Readings: QTcF	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Abnormal Electrocardiogram Readings: VR	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Abnormal Electrocardiogram Readings: PR Interval	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Abnormal Electrocardiogram Readings: QRS Duration	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Abnormal Electrocardiogram Readings: QRS Axis	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Abnormal Vital Signs: BP	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Abnormal Vital Signs: HR	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Abnormal Vital Signs: Temp	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Abnormal Vital Signs: RR	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Abnormal Physical Exams	0; 0; 0; 0; 0; 0	—
PRIMARY Assess PK Parameters for Single (Part 1) and Multiple (Part 2) SC Doses of PDM608 in Healthy Volunteers.	NA; NA; 23.4; 52.4; 203; 44.2	—
SECONDARY To Assess Immunogenicity Following Single and Multiple Doses of PDM608	4; 6; 5; 5; 6; 4	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05950906). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.