SER-252 for Parkinson's Disease

Recruiting at 5 trial locations

Overseen By Randall Moreadith, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Serina Therapeutics

Must be taking: Anti-Parkinsonian medications

Must not be taking: Antipsychotics, others

Disqualifiers: Atypical parkinsonism, Heart disease, Depression, Substance abuse, others

Compensation: Varies

Number of Visits: 2

Duration: 1 day

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SER-252 for individuals with Parkinson's Disease who experience motor fluctuations, or changes in movement control throughout the day. The study aims to evaluate the safety and effectiveness of a single dose of SER-252 compared to a placebo. Suitable candidates for this trial have a Parkinson's Disease diagnosis, noticeable daily movement changes, and stable Parkinson's medication. As a Phase 1 trial, participants will be among the first to receive SER-252, aiding researchers in understanding how this new treatment works in people.

Is there any evidence suggesting that SER-252 is likely to be safe for humans?

Research has shown that SER-252, which includes the drug apomorphine, is undergoing safety testing in people with Parkinson's Disease. Apomorphine has previously improved movement, suggesting its potential safety, as it has been studied in other contexts.

In early studies, researchers tested SER-252 under close supervision to observe how the body processes it and to identify any side effects. These initial results contribute to determining if SER-252 is safe for broader use. However, as this treatment remains in early testing, its safety continues to be carefully evaluated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Parkinson's Disease?

Unlike the standard Parkinson's treatments like levodopa or dopamine agonists, which often require frequent dosing and can lead to complications like motor fluctuations, SER-252 offers a unique delivery method. It uses a subcutaneous device known as enFuse® to administer a single dose of PEOZ-apomorphine, ensuring a steady release of medication. This could mean more consistent symptom control and fewer side effects. Researchers are excited about this approach because it targets Parkinson's symptoms in a potentially more efficient and patient-friendly way.

What evidence suggests that SER-252 might be an effective treatment for Parkinson's Disease?

Research has shown that apomorphine, the main ingredient in SER-252, can improve movement problems in people with Parkinson's Disease. A study that combined results from different research found that apomorphine helps with involuntary movements and changes in movement control in Parkinson's patients. In this trial, participants will receive either SER-252, a new version of apomorphine designed for skin absorption to provide a steady effect, or a placebo diluent product. This steady delivery aims to offer consistent symptom relief. While researchers continue to study SER-252, the proven benefits of apomorphine suggest it could be effective for Parkinson's Disease. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

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

Ability to return to the clinic for blood sampling, clinical and laboratory assessment on scheduled days, based upon cohort

Exclusion Criteria

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

History of exclusively diphasic, OFF state, myoclonic or dystonic dyskinesias without peak-dose choreiform dyskinesia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive a single ascending dose of SER-252 or placebo, with sentinel dosing approach and staggered administration

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including adverse events and pharmacokinetics

6 weeks

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• SER-252

How Is the Trial Designed?

Group I: SER-252 (PEOZ-apomorphine) Experimental Treatment 2 Interventions

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.

Group II: Diluent Product Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Serina Therapeutics

Lead Sponsor

Trials

1

Recruited

20+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07422675

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

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

2.

parkinsonsnewstoday.com

parkinsonsnewstoday.com/news/new-funding-support-ser-252-trial-advanced-parkinsons/

New funding to support SER-252 trial in advanced ...

Serina secured up to $30 million to support a Phase 1b trial of SER-252 in advanced Parkinson's, with dosing now underway.

3.

serinatx.com

serinatx.com/ser252

SER-252 (POZ-apomorphine)

POZ Apomorphine is a potential Best-in-Class treatment for advanced patients. Apomorphine is similar to LD in terms of efficacy, but not dependent on the ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41310565/

Identification of the efficacy and safety of apomorphine ...

Conclusion: The meta-analysis results indicate that apomorphine effectively improves dyskinesia and motor fluctuations in patients with PD.

5.

theglobeandmail.com

theglobeandmail.com/investing/markets/stocks/SER/pressreleases/563467/serina-therapeutics-advances-ser-252-parkinsons-trial-marking-a-key-early-milestone-for-investors/

Serina Therapeutics Advances SER-252 Parkinson's Trial ...

The main treatment is SER-252, a drug based on apomorphine given under the skin, paired with the wearable enFuse device. It is designed to give ...

6.

firstwordpharma.com

firstwordpharma.com/story/7114431

Serina Therapeutics Announces Dosing of First Patient in ...

The Phase 1b registrational study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of SER-252 in ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12661833/

Identification of the efficacy and safety of apomorphine ... - PMC

The pooled results from RCTs indicate that apomorphine treatment significantly improved patients' motor function compared to placebo.

8.

investors.serinatx.com

investors.serinatx.com/news/news-details/2025/Serina-Therapeutics-Announces-FDA-FeedbackSupports-Registrational-Trial-Design-of-SER-252-in-Advanced-Parkinsons-Disease-under-505b2-NDA-Pathway/default.aspx

News Details

The SER-252-1b study is a randomized, double-blind, placebo-controlled Phase 1b trial with single-ascending-dose (five cohorts of eight; n=40) ...