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PARKINSON DISEASE (Disorder)Phase 1NCT07422675

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

A Phase 1 study testing SER-252 (PEOZ-apomorphine) and enFuse in people with PARKINSON DISEASE (Disorder) and Advanced Parkinson's Disease, run by Serina Therapeutics at 6 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years
What is being tested?
SER-252 (PEOZ-apomorphine) and enFuse
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
6 sitesin 2 countries
Study dates
1 Feb 2026to 31 Jan 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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)

Who cannot join

  • 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)
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  • 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:
  • 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
  • Has been diagnosed with or history of a substance-related disorder (excluding nicotine and caffeine), including alcohol-related disorder by DSM-V criteria, during the 12 months prior to Screening
  • Tests positive at Screening for drugs of abuse (amphetamines (AMP), barbiturates (BAR), benzodiazepines (BZO), cocaine (COC), opiates (OPI), methamphetamines (MET), methadone (MTD), Phencyclidine (PCP), tetrahydrocannabinol (THC), tricyclic antidepressants (TCA)) Note: does not exclude patients on physician-prescribed medications.
  • Has ALT or AST levels greater than 2.5 times the ULN or bilirubin > 2.0 mg/dL, or > 34.2 µmol/L
  • Significant renal impairment as determined by eGFR, using Cockcroft-Gault method, less than or equal to 55 ml/min or serum creatinine >2.0 mg/dL or >177 µmol/L
  • Has a positive test result for HBsAg, HCV antibody, or HIV infection at Screening
  • Currently lactating or pregnant or planning to become pregnant during the study.
  • Previous intolerance of apomorphine
  • Currently participating in or has participated in another investigational study within the last 30 days or 5 half-lives, or 90 days for biologics

Trial locations and contacts

6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Randall Moreadith, MD, PhD contact

(256) 783-7649

rmoreadith@serinatherapeutics.com

6 sites in 2 countries

United States4 sites, 4 recruiting

  • Rocky Mountain Clinical Research

    Englewood, Colorado, 80113

    Heather Fasczewski, (248) 957-8940, Heather.Fasczewski@questri.com

    Meagan Salinas, MD

    Not yet recruiting

  • Quest Research Institute

    Farmington Hills, Michigan, 28555

    Heather Fasczewski, (248) 957-8940, Heather.Fasczewski@questri.com

    Aaron Ellenbogan, MD

    Recruiting

  • Velocity Clinical Research

    Hallandale, Florida, 33009

    William Torres, (954) 455-5757, wtorres@velocityclinical.com

    Beth Safirstein, MD

    Recruiting

  • K2 Medical Research LLC

    Maitland, Florida, 32751

    Sheila Baez-Torres, MD

    Recruiting

Other trials in United States

Australia2 sites, 2 recruiting

  • CMAX

    Adelaide, South Australia, 5000

    CMAX Clinical Research Group, 61 8 7088 7900, parkinsonsC16625@cmax.com.au

    Michele de Sciscio, MD

    Recruiting

  • Monash

    Melbourne, Victoria, 3170

    Monash House Research Centre, +61 3 8394 0700, research@monashhouse.com.au

    Purwa Joshi, MD

    Recruiting

Other trials in Australia

About this study

Official title: A Randomized, Placebo-Controlled, Single Ascending Dose (SAD) Study to Assess the Safety, Tolerability, and Pharmacokinetics of SER-252 in Patients With Parkinson's Disease and Motor Fluctuations

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

Read the detailed description

Participants will be enrolled into five sequential groups. Each group will include eight participants, dosed in a 3:1 ratio (six receiving SER-252 and two receiving placebo). All participants will receive a single dose of study drug. Each successive group will receive a higher dose level of SER-252 than the previous group. Some participants will receive a subcutaneous injection of SER-252, while others will receive placebo.

Single ascending dose (SAD) cohorts will utilize a sentinel dosing approach, with subsequent dosing conducted in a staggered manner if ongoing safety and tolerability assessments allow. In each cohort, the first two participants (one receiving SER-252 and one receiving placebo) will be dosed separately ahead of the remaining participants. These sentinel participants will be observed and evaluated as described in the protocol before dosing proceeds for the rest of the cohort.

Being tested
SER-252 (PEOZ-apomorphine), enFuse
Keywords
advanced Parkinson's Disease
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • enFuseDevice

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

Study groups in NCT07422675
Study groupRoleWhat they receive
SER-252 (PEOZ-apomorphine)ExperimentalSER-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.
Receives: Drug: SER-252 (PEOZ-apomorphine); Device: enFuse
Diluent ProductPlacebo comparatorThe 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.
Receives: Device: enFuse

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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).

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

  3. 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

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

  4. Change from Baseline in Vital Signs

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

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

  5. 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)

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

  6. Change from Baseline in Corrected QT Interval (QTcF)

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

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

  7. Time to Maximum Plasma Concentration (Tmax)

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

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

  8. Change from Baseline in Clinical Laboratory Parameters

    Mean change from baseline in hematology and serum chemistry panels.

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

  9. Fluctuation Index (FI)

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

    Measured: Day 1 through Day 8 (0-168 hours)

  10. 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.

    Measured: Screening/Day -1 and Day 8.

  11. Trough Concentration (Ctrough)

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

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

  12. Coefficient of Variation (CV%) for Exposure

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

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

  13. Distributional Half-Life (h)

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

    Measured: Day 1 through Day 8

  14. 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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2026
  2. Study start1 Feb 2026
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07422675
Sponsor's protocol ID
SER-252-1b
Status last verified
Jun 2026
First submitted
5 Feb 2026
Last updated
5 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SER-252 (PEOZ-apomorphine) and enFuse in people with PARKINSON DISEASE (Disorder) and Advanced Parkinson's Disease, run by Serina Therapeutics at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Randall Moreadith, MD, PhD ((256) 783-7649, rmoreadith@serinatherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and Temporal Profile of Treatment-Emergent Adverse Events (TEAEs) (time frame: From first dose through Day 21 (7 days after the Day 14 end-of-participation visit).). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07422675.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.

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