RecruitingPhase 1

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

United States, Australia40 participantsStarted 2026-02-01

Plain-language 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.

Who can participate

Age range

40 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. Diagnosis of secondary or atypical parkinsonism

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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

Timeframe: 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)

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

Change from Baseline in Vital Signs

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

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

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

Change from Baseline in Corrected QT Interval (QTcF)

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

Trial details

NCT IDNCT07422675

SponsorSerina Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01-31

Contact for this trial

Randall Moreadith, MD, PhD

(256) 783-7649 rmoreadith@serinatherapeutics.com

View on ClinicalTrials.gov More PARKINSON DISEASE (Disorder) trials

Who can participate

Age range

40 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. Diagnosis of secondary or atypical parkinsonism

What they're measuring

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

Timeframe: 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

Timeframe: 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)

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

Change from Baseline in Vital Signs

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

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

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

Change from Baseline in Corrected QT Interval (QTcF)

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