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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.

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

This trial accepts healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • LBT-3627

    Drug

    Synthetic peptide

  • Placebo

    Drug

    Vehicle

Treatment groups

64 Participants
are divided into 3 treatment groups
Group A: Healthy Volunteers - SADExperimental treatment 2 interventions
Group B: Parkinson's disease patients - SADExperimental treatment 2 interventions
Group C: Parkinson's disease patients - MADExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence, nature, and severity of adverse events [Safety and Tolerability]

Time frame
Day of treatment to end of follow-up period (1, 2 or 4 weeks)

Secondary outcomes

1

Maximum Plasma Concentration [Cmax]

The peak plasma concentration of a drug after administration.

Time frame
Day of treatment to end of follow-up period (1, 2 or 4 weeks)
2

Elimination half life [T1/2]

The time required for the concentration of the drug to reach half of its original value.

Time frame
Day of treatment to end of follow-up period (1, 2 or 4 weeks)
3

Time to reach Cmax [Tmax]

Time required to reach Cmax.

Time frame
Day of treatment to end of follow-up period (1, 2 or 4 weeks)
4

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).

Time frame
Day of treatment to end of follow-up period (1, 2 or 4 weeks)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Longevity Biotech Australia Pty Ltd (subsidiary)

Lead sponsor

Source ClinicalTrials.gov
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