Parkinson Disease
Conditions
Brief summary
Phase I a/b SAD/MAD study to evaluate safety and tolerability of LBT-3627 in both healthy volunteers and Parkinson's patients.
Detailed description
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.
Interventions
DRUGLBT-3627
Synthetic peptide
DRUGPlacebo
Vehicle
Sponsors
Longevity Biotech Australia Pty Ltd (subsidiary)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Placebo controlled, double blind (patient and investigator)
Intervention model description
Placebo controlled, double blind, SAD and MAD dose escalation
Eligibility
Sex/Gender
ALL
Age
30 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
Both cohorts (Healthy Volunteers and Parkinson's Disease) Key inclusion criteria * Male or female, 30-89 years inclusive at screening * BMI 18-32 kg/m² * Vital signs, ECG (QTcF \<450 ms male / \<470 ms female), and safety labs without clinically significant abnormality; no orthostatic hypotension * Women of non-childbearing potential, or using highly effective contraception per protocol Key
Exclusion criteria
* Immunomodulators / steroids - HV: any (incl. OTC) within 90 days; PD: systemic within 60 days and topical/nasal-inhaled OTC within 7 days (both waivable only with Sponsor approval) * Vaccine within 60 days (HV) / 45 days (PD) of first dose * CoQ10 within 5 days * Inadequate renal function (CrCl ≤ 60 mL/min; ≤ 79 if HV under 40), or LFTs / bilirubin \> 1.5× ULN * Clinically significant cardiovascular, hepatic, renal, neurological, or psychiatric disease * Active infection requiring systemic anti-infectives within 14 days; positive HBV/HCV/HIV serology Parkinson's Disease participants - additional key inclusion criteria * PD diagnosis by a neurologist/geriatrician, 6 months to \< 11 years before first dose, per MDS clinical diagnostic criteria * Hoehn \& Yahr stage 1-3 * If on levodopa: stable ≥ 2 months and able to withhold ≥ 12 hours (overnight) around dosing/assessments; if not, remain treatment-naïve through end of study Parkinson's Disease participants - additional key
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, nature, and severity of adverse events [Safety and Tolerability] | Day of treatment to end of follow-up period (1, 2 or 4 weeks) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration [Cmax] | Day of treatment to end of follow-up period (1, 2 or 4 weeks) | The peak plasma concentration of a drug after administration. |
| Elimination half life [T1/2] | Day of treatment to end of follow-up period (1, 2 or 4 weeks) | The time required for the concentration of the drug to reach half of its original value. |
| Time to reach Cmax [Tmax] | Day of treatment to end of follow-up period (1, 2 or 4 weeks) | Time required to reach Cmax. |
| Volume of Distribution [Vd] | Day of treatment to end of follow-up period (1, 2 or 4 weeks) | The apparent volume in which a drug is distributed (i.e., the parameter relating drug concentration in plasma to drug amount in the body). |
| Concentration [C] | Day of treatment to end of follow-up period (1, 2 or 4 weeks) | Amount of drug in a given volume of plasma |
| Area under the curve [AUC] | Day of treatment to end of follow-up period (1, 2 or 4 weeks) | The integral of the concentration-time curve (after a single dose or in steady state). |
| Bioavailability [f] | Day of treatment to end of follow-up period (1, 2 or 4 weeks) | The systemically available fraction of a drug. |
| Clearance [CL] | Day of treatment to end of follow-up period (1, 2 or 4 weeks) | The volume of plasma cleared of the drug per unit time. |
Countries
Australia
Contacts
CONTACTTim Porter, MBBS, FANZCA, MBioethics
Outcome results
None listed