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

Part of paid clinical trials in Englewood, Colorado.

Sponsor
Serina Therapeutics
Study ID
NCT07422675
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Parkinson's Disease
  • PARKINSON DISEASE (Disorder)

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

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

Study Details

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

Key Dates

Start date
Feb 1, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SER-252 (PEOZ-apomorphine)
    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.
  • Placebo Comparator: Diluent Product
    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.

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). ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Rocky Mountain Clinical ResearchEnglewoodColorado80113
Heather Fasczewski
[email protected]
(248) 957-8940
Meagan Salinas, MD (PRINCIPAL_INVESTIGATOR)
Velocity Clinical ResearchHallandaleFlorida33009
William Torres
[email protected]
(954) 455-5757
Beth Safirstein, MD (PRINCIPAL_INVESTIGATOR)
K2 Medical Research LLCMaitlandFlorida32751
Sheila Baez-Torres, MD (PRINCIPAL_INVESTIGATOR)
Quest Research InstituteFarmington HillsMichigan28555
Heather Fasczewski
[email protected]
(248) 957-8940
Aaron Ellenbogan, MD (PRINCIPAL_INVESTIGATOR)

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Rocky Mountain Clinical Research· Englewood, COVelocity Clinical Research· Hallandale, FLK2 Medical Research LLC· Maitland, FLQuest Research Institute· Farmington Hills, MI

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