SAD Study in Patients With Parkinson's Disease and Motor Fluctuations

NCT07422675 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: SER-252-1b
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 6

Brief Summary

This is a randomized, placebo-controlled, single ascending dose (SAD) study of SER-252 in participants with Parkinson's Disease (PD) and motor fluctuations.

Conditions

PARKINSON DISEASE (Disorder); Advanced Parkinson's Disease

Keywords

advanced Parkinson's Disease

Outcome Measures

Primary Outcomes (14)

• Incidence and Temporal Profile of Treatment-Emergent Adverse Events (TEAEs)

  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.

  From first dose through Day 21 (7 days after the Day 14 end-of-participation visit).

• Incidence of Moderate or Severe TEAEs Related to Study Intervention

  Proportion of participants experiencing moderate or severe TEAEs related to study intervention (including possibly and probably related).

  From first dose through Day 21 (7 days after the Day 14 end-of-participation visit).

• Incidence of Serious Adverse Events (SAEs), including suicidality by Columbia-Suicide Severity Rating Scale (C-SSRS)

  Proportion of participants with SAEs (ICH-GCP), including suicidality identified via C-SSRS

  From first dose through Day 44 (30 days after the Day 14 end-of-participation visit).

• Change from Baseline in Vital Signs

  Mean change from baseline in systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature.

  Baseline to Day 8 (with Day 14 follow-up vitals also collected)

• Area under the concentration-time curve (AUC0-24, AUC0-96, AUC0-∞)

  AUC from time zero to infinity hours post-dose, calculated using noncompartmental methods (ng·h/mL)

  Day 1 through Day 8 (0-168 hours post-dose)

• Change from Baseline in Corrected QT Interval (QTcF)

  Mean change from baseline in Fridericia-corrected QT interval (QTcF) from 12-lead ECGs. (millisecond (ms))

  Baseline to Day 8 (with Day 14 safety follow-up ECGs).

• Time to Maximum Plasma Concentration (Tmax)

  Observed time to reach Cmax (first occurrence), based on the protocol-defined sampling schedule. (hours)

  Day 1 through Day 8 (0-168 hours post-dose).

• Change from Baseline in Clinical Laboratory Parameters

  Mean change from baseline in hematology and serum chemistry panels.

  Baseline to Day 8 (laboratories at safety follow-up only if needed to follow up abnormalities).

• Fluctuation Index (FI)

  FI calculated as (Cmax - Cmin) / Cavg over 0-168 hours.

  Day 1 through Day 8 (0-168 hours)

• Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS)

  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.

  Screening/Day -1 and Day 8.

• Trough Concentration (Ctrough)

  Observed plasma concentrations at nominal trough timepoints: 24, 48, 72, 96, 120, 144, and 168 hours post-dose. (ng/mL)

  Days 2-8 (24-168 hours post-dose).

• Coefficient of Variation (CV%) for Exposure

  Between-participant variability in key PK parameters (e.g., Cmax, AUC), calculated as 100 × (SD / mean).

  Day 1 through Day 8 (0-168 hours).

• Distributional Half-Life (h)

  Distributional half-life estimated from the distribution phase of the concentration-time profile, when model assumptions permit. (hours)

  Day 1 through Day 8

• Maximum Plasma Concentration (Cmax)

  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)

  Day 1 through Day 8 (0-168 hours post-dose)

Other Outcomes (4)

• Exploratory Efficacy Endpoint: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II

  Change from Baseline at Day 8

• Exploratory Efficacy Endpoint: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III - Change from Baseline at 4 Hours

  Baseline to 4 hours post dose

• Exploratory Efficacy Endpoint: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III - Maximum Daily Change from Baseline

  Baseline to 12 hours post-dose

Study Arms (2)

SER-252 (PEOZ-apomorphine)

EXPERIMENTAL

SER-252 (PEOZ-apomorphine) Single subcutaneous dose delivered by enFuse® on body device; weight-based apomorphine equivalents/kg by cohort: 0.48, 0.60, 0.75, 0.90, 1.0 mg-eq/kg. SER-252 drug product consists of 20mg lyophilized apomorphine equivalent in SER-252 drug substance in a sterile vial for reconstitution with a diluent product containing 15mM acetate buffer at pH 6.0 and 7% trehalose to maintain final pH and isotonicity in the reconstituted product.

Drug: SER-252 (PEOZ-apomorphine); Device: enFuse

Diluent Product

PLACEBO COMPARATOR

The SER-252 Diluent Product, 12 ml size will be used as the placebo formulation. The appearance of the diluent product is clear and colorless. Matching subcutaneous administration by the same device.

Device: enFuse

Interventions

SER-252 (PEOZ-apomorphine) DRUG

SER-252 drug product consists of 20mg lyophilized apomorphine equivalent in SER-252 drug substance in a sterile vial for reconstitution with a diluent product containing 15mM acetate buffer at pH 6.0 and 7% trehalose to maintain final pH and isotonicity in the reconstituted product.

SER-252 (PEOZ-apomorphine)

enFuse DEVICE

The enFuse® device is a sterile, non-pyrogenic, user-filled, single-use, fixed-dose subcutaneous dose delivery system.

Diluent Product; SER-252 (PEOZ-apomorphine)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male participants 40-80 years of age, inclusive, at the time of screening
• Diagnosis of idiopathic Parkinson's disease consistent with UK Brain Bank and MDS Research Criteria; must include bradykinesia with sequence effect, motor asymmetry if no rest tremor, and a reliable, visible response to levodopa
• On a stable regimen of anti-Parkinsonian medication for at least 4 weeks prior to Screening; MAOBIs must be stable for at least 12 weeks prior to Screening
• Routine early-morning OFF, corroborated by investigator interview at Screening
• Presence of a total daily OFF time duration of ≥2 hours during the waking day based on participant self-assessment and Investigator's judgment
• \*Hoehn and Yahr scale ≤ 3 in the ON state during screening (\*part of the MDS- UPDRS Part III assessment)
• Levodopa administration at least 4 times daily (immediate or extended release) or three times daily (Rytary or Crexont)
• Ability to return to the clinic for blood sampling, clinical and laboratory assessment on scheduled days, based upon cohort
• Montreal Cognitive Assessment ≥ 24
• Women of child-bearing potential (WOCBP) who are sexually active with a male partner must use a reliable method of contraception from the time of consent through at least 3 months after the last dose of study medication. Reliable methods of contraception include oral contraceptive or long-term injectable or implantable hormonal contraceptive, or intra-uterine devices when used in combination with male condoms, and must have a negative serum pregnancy test at Screening and negative urine pregnancy test at baseline. Males who are sexually active and whose partners are females of childbearing potential must agree to use male condoms from the time of consent through 3 months after administration of the last dose of study drug, and their partners must be willing to use a highly effective method of contraception from screening through 3 months after administration of the last dose of study drug.
• Willing and able to comply with all study activities and requirements, including safety follow-up
• Provide written informed consent
• Approved by a central Enrollment Authorization Committee (EAC)

You may not qualify if:

• Diagnosis of secondary or atypical parkinsonism
• Any previous procedure or therapy designed to provide continuous levodopa or stimulation of dopaminergic tone (i.e., Duopa, apomorphine), surgery for PD (i.e., DBS), or anticipation of these during the study
• History of exclusively diphasic, OFF state, myoclonic or dystonic dyskinesias without peak-dose choreiform dyskinesia
• Clinically debilitating motor complications as determined by the principal investigator or delegate (severe, disabling dyskinesias or severe OFF)
• Participant inability to differentiate motor states (OFF/ON/ON with mild/moderate/severe dyskinesias) after training
• Clinically significant orthostatic hypotension (consistently symptomatic or requires medication)
• Clinically significant hallucinations requiring antipsychotic use
• Clinically significant medical, surgical, psychiatric, or laboratory abnormalities that in the judgment of the principal investigator or delegate would preclude adequate participation or completion of the study
• Clinically significant ECG abnormalities at Screening
• Prolonged Fridericia-corrected QT (QTcF) interval on ECG at Screening (defined as a QTcF interval of \>450 msec for males and 470 for females)
• Clinically significant heart disease within 2 years of Screening, defined as follows:
• A. Significant cardiac event within 12 weeks prior to Screening (e.g., admission for myocardial infarction, unstable angina, or decompensated heart failure), angina pectoris or episode of congestive heart failure with symptoms \> grade 2 New York Heart Association classification, or presence of cardiac disease that in the opinion of the investigator increases the risk of ventricular arrhythmia B. History of complex arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia) that was symptomatic or required treatment (Common Terminology Criteria for Adverse Events grade 3) C. Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia D. Symptomatic bradycardia, sick sinus syndrome or atrioventricular block greater than first degree in the absence of a pacemaker E. Unexplained syncope F. Brugada syndrome G. Hypertrophic cardiomyopathy
• Active major depressive disorder or history of clinically significant impulse control disorder, in the opinion of the Principal Investigator or delegate, or EAC.
• Note: Participants receiving treatment for depression with antidepressants may be enrolled if they have been on a stable daily dose of the antidepressant for at least 8 weeks prior to Screening.
• Has active suicidal ideation within one year prior to Screening as determined by the C-SSRS (answer of "yes" on questions 4 or 5) or attempted suicide within the last 5 years

Sponsors & Collaborators

• Serina Therapeutics: lead

Study Sites (6)

Rocky Mountain Clinical Research

Englewood, Colorado, 80113, United States

NOT YET RECRUITING

Velocity Clinical Research

Hallandale, Florida, 33009, United States

RECRUITING

K2 Medical Research LLC

Maitland, Florida, 32751, United States

RECRUITING

Quest Research Institute

Farmington Hills, Michigan, 28555, United States

RECRUITING

CMAX

Adelaide, South Australia, 5000, Australia

RECRUITING

Monash

Melbourne, Victoria, 3170, Australia

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Randall Moreadith, MD, PhD

CONTACT

(256) 783-7649; rmoreadith@serinatherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 20, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); AU (2)