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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.
Phase I a/b SAD/MAD study to evaluate safety and tolerability of LBT-3627 in both healthy volunteers and Parkinson's patients.
Study details:
Evaluate the safety and tolerability of LBT-3627 in both a single and multiple ascending dose study. Phase Ia will explore safety and tolerability first in healthy volunteers then followed by Parkinson's patients after a single dose. Dose levels will escalate per cohort.
Phase Ib will explore safety and tolerability in Parkinson's patients after multiple doses. Dose levels will escalate per cohort.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 30 and older
Healthy volunteers accepted : Yes
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-07-16
Primary completion: 2025-03-01
Study completion finish: 2025-03-01
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT06466525
Intervention or treatment
DRUG: LBT-3627
DRUG: Placebo
Conditions
- • Parkinson Disease
Find a site
Closest Location:
Alfred Hospital
Research sites nearby
Select from list below to view details:
Alfred Hospital
Melbourne, Victoria, Australia
Nucleus Networks
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Healthy Volunteers - SAD
| DRUG: LBT-3627
|
EXPERIMENTAL: Parkinson's disease patients - SAD
| DRUG: LBT-3627
|
EXPERIMENTAL: Parkinson's disease patients - MAD
| DRUG: LBT-3627
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Incidence, nature, and severity of adverse events [Safety and Tolerability] | Not Specified | Day of treatment to end of follow-up period (1, 2 or 4 weeks) |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Maximum Plasma Concentration [Cmax] | The peak plasma concentration of a drug after administration. | Day of treatment to end of follow-up period (1, 2 or 4 weeks) |
Elimination half life [T1/2] | The time required for the concentration of the drug to reach half of its original value. | Day of treatment to end of follow-up period (1, 2 or 4 weeks) |
Time to reach Cmax [Tmax] | Time required to reach Cmax. | Day of treatment to end of follow-up period (1, 2 or 4 weeks) |
Volume of Distribution [Vd] | The apparent volume in which a drug is distributed (i.e., the parameter relating drug concentration in plasma to drug amount in the body). | Day of treatment to end of follow-up period (1, 2 or 4 weeks) |
Concentration [C] | Amount of drug in a given volume of plasma | Day of treatment to end of follow-up period (1, 2 or 4 weeks) |
Area under the curve [AUC] | The integral of the concentration-time curve (after a single dose or in steady state). | Day of treatment to end of follow-up period (1, 2 or 4 weeks) |
Clearance [CL] | The volume of plasma cleared of the drug per unit time. | Day of treatment to end of follow-up period (1, 2 or 4 weeks) |
Bioavailability [f] | The systemically available fraction of a drug. | Day of treatment to end of follow-up period (1, 2 or 4 weeks) |
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