← Back to Search

Other

PDM608 Safety Study in Healthy Adults

Phase 1
Recruiting
Research Sponsored by Calibr, a division of Scripps Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part 1: day 1 through day 22; part 2: day 1 through day 60
Awards & highlights

Study Summary

This trial will study a new drug to see if it's safe and works well in adults without health problems.

Who is the study for?
Healthy adults who can join this trial include men and non-childbearing potential women with a BMI of 18.0 to 33.0 kg/m2, willing to use contraception. Excluded are those with serious allergies, significant health issues, recent illness/surgery, drug/alcohol abuse history, or taking certain medications.Check my eligibility
What is being tested?
The study is testing PDM608's safety and how the body processes it compared to a placebo (a substance with no active drug). Participants will not know if they're getting PDM608 or the placebo as part of the study's design.See study design
What are the potential side effects?
While specific side effects for PDM608 aren't listed here, common ones in trials may include nausea, headaches, dizziness or allergic reactions. The trial aims to identify any side effects from taking PDM608.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part 1: day 1 through day 22; part 2: day 1 through day 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and part 1: day 1 through day 22; part 2: day 1 through day 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assess PK parameters for single (Part 1) and multiple (Part 2) SC doses of PDM608 in healthy volunteers.
Number of participants with abnormal electrocardiogram readings: PR interval
Number of participants with abnormal electrocardiogram readings: QRS axis
+10 more
Secondary outcome measures
To assess immunogenicity following single and multiple doses of PDM608

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2 MAD SC PDM608Experimental Treatment1 Intervention
Multiple ascending dose, subcutaneous administration of PDM608 once weekly for 4 weeks.
Group II: Part 1 SAD SC PDM608Experimental Treatment1 Intervention
Single ascending dose, subcutaneous administration of PDM608
Group III: Part 1 SAD SC PlaceboPlacebo Group1 Intervention
Single ascending dose, subcutaneous administration of matching placebo
Group IV: Part 2 MAD SC PlaceboPlacebo Group1 Intervention
Multiple ascending dose, subcutaneous administration of placebo once weekly for 4 weeks.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Alzheimer's Drug Discovery FoundationOTHER
21 Previous Clinical Trials
3,053 Total Patients Enrolled
Calibr, a division of Scripps ResearchLead Sponsor
5 Previous Clinical Trials
169 Total Patients Enrolled
Michael J. Fox Foundation for Parkinson's ResearchOTHER
112 Previous Clinical Trials
535,033 Total Patients Enrolled

Media Library

PDM608 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05950906 — Phase 1
Parkinson's Disease Research Study Groups: Part 1 SAD SC PDM608, Part 1 SAD SC Placebo, Part 2 MAD SC PDM608, Part 2 MAD SC Placebo
Parkinson's Disease Clinical Trial 2023: PDM608 Highlights & Side Effects. Trial Name: NCT05950906 — Phase 1
PDM608 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05950906 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the study include geriatric participants?

"All participants in this trial must fall between 18-65 years of age to be eligible for inclusion."

Answered by AI

Am I eligible to volunteer for this medical research?

"To be considered for this trial, patients must have been diagnosed with Parkinson's disease and range in age between 18-65. Currently, 88 individuals are being sought out to participate."

Answered by AI

Are new volunteers still being recruited for this experiment?

"Affirmative, the clinical trial is actively recruiting according to information published on clinicaltrials.gov. This study was submitted to the website on June 27th 2023 and updated most recently on July 10th 2023. It needs 88 people across 1 site in order to complete its objectives."

Answered by AI

What is the enrolment capacity of this research experiment?

"Correct. Clinicaltrials.gov shows that this trial is actively seeking participants, with the protocol being initially posted on June 27th 2023 and most recently updated on July 10th of the same year. 88 individuals need to be recruited from one medical site for successful completion of this research study."

Answered by AI

Has the FDA declared Part 1 SAD SC PDM608 to be safe and effective?

"As this is the initial stage of research, our team has assigned Part 1 SAD SC PDM608 a safety rating of 1 due to limited evidence for its efficacy and safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study to Assess PDM608 in Healthy Adult Subjects
2023. "Study to Assess PDM608 in Healthy Adult Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05950906.
~48 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top