SAD Study of SER-252 for Parkinson's Disease with Motor Fluctuations
This study is testing a new drug called SER-252 (PEOZ-apomorphine) delivered using a device called enFuse. It's for people aged 40-80 who have Parkinson's disease and experience motor fluctuations (changes in their movement abilities). The main goal is to see how safe SER-252 is and what side effects it might cause. Researchers will look at how often side effects happen and how severe they are. This is a single ascending dose (SAD) study, meaning different groups of participants will receive increasing doses of SER-252, or a placebo (an inactive substance). The study plans to enroll 40 participants in total. The current recruitment status is unclear.
- Study design
- This is a randomized, placebo-controlled study with 40 participants divided into five groups. Each group will have six participants receiving SER-252 and two receiving a placebo.
- What's involved
- You will receive a single dose of the study drug, either SER-252 or a placebo, given as a subcutaneous injection (under the skin) using the enFuse device.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for 21 days after your first dose, and serious adverse events will be tracked for 44 days after your first dose.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
SAD Study in Patients With Parkinson's Disease and Motor Fluctuations
At a glance
Conditions
NCT07422675
Where you'd take part
This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
CMAX
Adelaide, South Australia, Australiastudy coordinator listed
Recruiting
Monash
Melbourne, Victoria, Australiastudy coordinator listed
Recruiting
Quest Research Institute
Farmington Hills, Michiganstudy coordinator listed
Recruiting
Rocky Mountain Clinical Research
Englewood, Coloradostudy coordinator listed
Not yet recruiting
Velocity Clinical Research
Hallandale, Floridastudy coordinator listed
Recruiting
K2 Medical Research LLC
Maitland, Floridano site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Incidence and Temporal Profile of Treatment-Emergent Adverse Events (TEAEs)From first dose through Day 21 (7 days after the Day 14 end-of-participation visit).
Proportion of participants with TEAEs (new onset or worsening) and temporal profile post-dose; TEAEs summarized by type/nature, severity/intensity, seriousness, and relationship to study treatment per protocol.
- Incidence of Moderate or Severe TEAEs Related to Study InterventionFrom first dose through Day 21 (7 days after the Day 14 end-of-participation visit).
Proportion of participants experiencing moderate or severe TEAEs related to study intervention (including possibly and probably related).
- Incidence of Serious Adverse Events (SAEs), including suicidality by Columbia-Suicide Severity Rating Scale (C-SSRS)From first dose through Day 44 (30 days after the Day 14 end-of-participation visit).
Proportion of participants with SAEs (ICH-GCP), including suicidality identified via C-SSRS
- Change from Baseline in Vital SignsBaseline to Day 8 (with Day 14 follow-up vitals also collected)
Mean change from baseline in systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature.
- Area under the concentration-time curve (AUC0-24, AUC0-96, AUC0-∞)Day 1 through Day 8 (0-168 hours post-dose)
AUC from time zero to infinity hours post-dose, calculated using noncompartmental methods (ng·h/mL)
- Change from Baseline in Corrected QT Interval (QTcF)Baseline to Day 8 (with Day 14 safety follow-up ECGs).
Mean change from baseline in Fridericia-corrected QT interval (QTcF) from 12-lead ECGs. (millisecond (ms))
- Time to Maximum Plasma Concentration (Tmax)Day 1 through Day 8 (0-168 hours post-dose).
Observed time to reach Cmax (first occurrence), based on the protocol-defined sampling schedule. (hours)
- Change from Baseline in Clinical Laboratory ParametersBaseline to Day 8 (laboratories at safety follow-up only if needed to follow up abnormalities).
Mean change from baseline in hematology and serum chemistry panels.
- Fluctuation Index (FI)Day 1 through Day 8 (0-168 hours)
FI calculated as (Cmax - Cmin) / Cavg over 0-168 hours.
- Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS)Screening/Day -1 and Day 8.
Incidence and severity of impulsive-compulsive behaviors assessed by QUIP-RS. The QUIP-RS total score ranges 0-112, with higher scores indicating more severe symptoms.
- Trough Concentration (Ctrough)Days 2-8 (24-168 hours post-dose).
Observed plasma concentrations at nominal trough timepoints: 24, 48, 72, 96, 120, 144, and 168 hours post-dose. (ng/mL)
- Coefficient of Variation (CV%) for ExposureDay 1 through Day 8 (0-168 hours).
Between-participant variability in key PK parameters (e.g., Cmax, AUC), calculated as 100 × (SD / mean).
- Distributional Half-Life (h)Day 1 through Day 8
Distributional half-life estimated from the distribution phase of the concentration-time profile, when model assumptions permit. (hours)
- Maximum Plasma Concentration (Cmax)Day 1 through Day 8 (0-168 hours post-dose)
Cmax of SER-252-derived apomorphine following a single subcutaneous dose, derived from plasma concentrations collected at: pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12 hours on Day 1; and 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and 168 hours post-dose.(ng/mL)