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.

ConditionParkinson Disease

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age30-89

SponsorLongevity Biotech Australia Pty Ltd (subsidiary)

About this trial

Phase I a/b SAD/MAD study to evaluate safety and tolerability of LBT-3627 in both healthy volunteers and Parkinson's patients.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

LBT-3627
Placebo

Treatment groups

64 Participants

are divided into 3 treatment groups

Sponsors and collaborators

Longevity Biotech Australia Pty Ltd (subsidiary)

Lead sponsor

Source ClinicalTrials.gov