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Tests treatment safety and results for Parkinson Disease
Official title A Two-Part Single and Multiple Ascending Dose Trial of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LBT-3627 in Healthy Participants and in Participants With Parkinson's Disease.
ClinicalTrials.gov ID: NCT06466525
What this study is testing
What is LBT-3627?
LBT-3627 is an investigational medicine, being studied as a potential treatment for parkinson disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Phase I a/b SAD/MAD study to evaluate safety and tolerability of LBT-3627 in both healthy volunteers and Parkinson's patients.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 89. Healthy volunteers may be eligible.
You may be able to join if
- (Everyone) Participants will be included in the study only if they satisfy all the following criteria:
- Must have given written informed consent, before any study-related activities are carried out and must be able to understand the full nature and...
- Healthy male or female, aged between 30 and 89 years, inclusive at screening.
- Body mass index (BMI) of 18 to 32 kg/m2, inclusive.
- Physical examination without any additional clinically relevant findings
You likely can't join if
- (Everyone) Participants will be excluded from the study if there is evidence of any of the following:
- Use of immunomodulators (including steroids and topical/oral/inhaled OTC glucocorticoids) within the past 60 days prior to the start of the first...
- Use of coenzyme Q10 within 5 days prior to the start of the first dose of study drug. (to be assessed at screening and Day -1)
- Received a vaccine within 60 days of first dose of study drug (to be assessed at screening and Day -1)
- History of hypersensitivity reaction, anaphylaxis or other clinically significant reactions or known allergy to any of the study drug ingredients.
- History of transient ischemic attack or stroke or any unexplained loss of consciousness within 12 months of screening
See the full eligibility criteria
Who can join
- (Everyone) Participants will be included in the study only if they satisfy all the following criteria:
- Must have given written informed consent, before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
- Healthy male or female, aged between 30 and 89 years, inclusive at screening.
- Body mass index (BMI) of 18 to 32 kg/m2, inclusive.
- Physical examination without any additional clinically relevant findings
- Systolic blood pressure in the range of 90 to 140 mmHg (inclusive) and diastolic blood pressure in the range of 40 to 90 (inclusive) mmHg after 5 minutes in supine/semi-supine, and subsequently after 3 minutes of...
- Heart rate in the range of 50 to 100 beats/minute after 5 minutes rest in supine/semi-supine position, and subsequently after 3 minutes of standing position. Note: Participants with orthostatic hypotension are not...
- Must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test on Day -1, prior to dose administration.
- Must agree not to donate ova or attempt to become pregnant from the time of signing consent until at least 30 days after the last dose of study drug.
- If not exclusively in a same-sex relationship, must agree to remain abstinent throughout the study, or must agree to use adequate contraception (which is defined as use of a condom by the male partner combined with use...
- Agree not to donate sperm from the time of signing consent until at least 30 days after the last dose of study drug.
- If engaging in sexual intercourse with a female partner who could become pregnant, agree to use adequate contraception (defined as use of a condom plus a highly effective method of contraception from the time of signing...
- If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, agree to use a condom from the time of signing consent until at least 30 days after the last dose of...
What rules you out
- (Everyone) Participants will be excluded from the study if there is evidence of any of the following:
- Use of immunomodulators (including steroids and topical/oral/inhaled OTC glucocorticoids) within the past 60 days prior to the start of the first dose of study drug, unless approval is given by the study Sponsor (to be...
- Use of coenzyme Q10 within 5 days prior to the start of the first dose of study drug. (to be assessed at screening and Day -1)
- Received a vaccine within 60 days of first dose of study drug (to be assessed at screening and Day -1)
- History of hypersensitivity reaction, anaphylaxis or other clinically significant reactions or known allergy to any of the study drug ingredients.
- History of transient ischemic attack or stroke or any unexplained loss of consciousness within 12 months of screening
- Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection upon admission to clinic on Day -1 (SARS-CoV-2 testing to be performed according to site standard process) or participant report of 'Long-COVID' any...
- History of any clinically significant disorder (which, in the opinion of the Investigator [or delegate] would make implementation of the protocol or interpretation of study results difficult, or that would put the...
- History of surgery or hospitalisation within 12 weeks prior to screening, or surgery planned during the study.
- Lack of suitable veins for multiple venepunctures/cannulations as assessed by the Investigator or delegate at screening.
- Presence of any tattoos or scarring which (in the opinion of the Investigator [or delegate]) would interfere with injection site reaction assessments.
- Laboratory results at screening that indicate inadequate renal function (estimated creatinine clearance (CrCl) \< 60mL/min (if either healthy and aged 40 and above or a Parkinson's patient) or \< 79mL/min (if healthy...
- Liver function test results elevated more than 1.5-fold above the ULN for gamma glutamyl transferase (GGT), alkaline phosphatase (ALP), aspartate aminotransferase (AST) or alanine aminotransferase (ALT). Volunteers with...
- Liver function tests outside the normal range for bilirubin (more than 1.5-fold above the ULN for total bilirubin).
- Any clinically relevant laboratory finding or medical condition that could place the volunteer at risk for participation in the study.
- Any active infection requiring systemic antibiotic, antifungal, or antiviral medication within 14 days prior to first dose of study drug (to be confirmed at screening and Day 1).
- Concurrent enrolment in another clinical study, or participation in another clinical study within 90 days prior to screening.
- Regular consumption of \>10 standard alcoholic drinks/week where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer [4.9% Alc/Vol], 100 mL wine [12% Alc/Vol], 30 mL spirit [40% Alc/Vol]).
- Positive alcohol breath or plasma test at screening or upon admission to the clinic on Day -1.
- Positive urine drugs of abuse test at screening or upon admission to the clinic on Day -1.
- Participant has a positive cotinine test upon admission to the clinic on Day -1.
- Participant smokes more than 5 cigarettes or equivalent per week, and/or participant is unwilling to abstain from smoking for 72 hours prior to check-in on Day -1 and throughout the confinement period at the study site.
- Use of cannabis or delta-9- tetrahydrocannabinol (THC), including for medicinal purposes, within 90 days prior to the start of the first dose of study drug, and/or participant is unwilling to abstain from use during the...
- Participant is breastfeeding or pregnant, or planning to breastfeed or become pregnant during the study.
- Known substance abuse or medical, psychological, or social conditions that, in the opinion of the PI (or delegate), may interfere with the participants inclusion in the clinical study or evaluation of the clinical study...
- Positive Hepatitis B surface antigen (HBsAg), Hepatitis C (HepC) virus antibody, or human immunodeficiency (HIV) antibody tests at screening.
- Participant has donated blood/blood products, experienced significant (\> 500 mL) blood loss within 3 months prior to the first dose administration or receipt of a blood transfusion within 1 year prior to the first dose...
- Any other condition or prior therapy that in the opinion of the Investigator (or delegate) would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study...
- Diagnosis of Parkinson's disease as defined by:
- Evidence (written confirmation by a neurologist or geriatrician) of diagnosis of Parkinson's disease between 1-10 years prior to first dose administration. Note: Criteria for diagnosis of Parkinson's disease is per the...
- Progressive asymmetric onset of bradykinesia
- Muscle rigidity and/or rest tremor (4- to 6-Hz tremor in the fully resting limb) o Hoehn and Yahr score of 1-3 (inclusive) o Not diagnosed with any other neurodegenerative diseases. o If on levodopa containing...
- If not on levodopa containing medications: To be able to remain treatment naïve throughout the study from screening through to the final EoS visit. Additional Exclusion Criteria (Parkinson's Disease Participants)...
- Any history of cancer within the last 5 years (excluding basal cell or squamous epithelial carcinomas of the skin that have been resected with clear margins and with no evidence of recurrence for at least 12 months).
- History of non-elective and/or non-routine surgery or hospitalisation within 12 weeks prior to screening, or surgery planned during the study, at the discretion of the PI.
The study team makes the final eligibility decision.
Where it's taking place
- Melbourne, Victoria, Australia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 89 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.