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.

August 20, 2026 updated by: Longevity Biotech Australia Pty Ltd (subsidiary)
Phase I a/b SAD/MAD study to evaluate safety and tolerability of LBT-3627 in both healthy volunteers and Parkinson's patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia
      • Melbourne, Victoria, Australia
        • Active, not recruiting
        • Nucleus Networks

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 exclusion criteria

  • Prior PD brain surgery, focused ultrasound, or neuromodulation; no anti-amyloid/anti-tau biologics
  • Antibiotics within 30 days; OTC pre/probiotics; ≥ 3 unexplained falls in 12 months

Note: Additional protocol-defined criteria apply.

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?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy Volunteers - SAD
Single dose of LBT-3627 administered to healthy volunteers
Drug: Placebo
Vehicle
Drug: LBT-3627
Synthetic peptide
Experimental: Parkinson's disease patients - SAD
Single dose of LBT-3627 administered to Parkinson's disease patients
Drug: Placebo
Vehicle
Drug: LBT-3627
Synthetic peptide
Experimental: Parkinson's disease patients - MAD
Multiple doses of LBT-3627 administered to Parkinson's disease patients
Drug: Placebo
Vehicle
Drug: LBT-3627
Synthetic peptide

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Plasma Concentration [Cmax]
Time Frame: Day of treatment to end of follow-up period (1, 2 or 4 weeks)
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]
Time Frame: 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.
Day of treatment to end of follow-up period (1, 2 or 4 weeks)
Time to reach Cmax [Tmax]
Time Frame: Day of treatment to end of follow-up period (1, 2 or 4 weeks)
Time required to reach Cmax.
Day of treatment to end of follow-up period (1, 2 or 4 weeks)
Volume of Distribution [Vd]
Time Frame: 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).
Day of treatment to end of follow-up period (1, 2 or 4 weeks)
Concentration [C]
Time Frame: Day of treatment to end of follow-up period (1, 2 or 4 weeks)
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]
Time Frame: 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).
Day of treatment to end of follow-up period (1, 2 or 4 weeks)
Clearance [CL]
Time Frame: 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.
Day of treatment to end of follow-up period (1, 2 or 4 weeks)
Bioavailability [f]
Time Frame: Day of treatment to end of follow-up period (1, 2 or 4 weeks)
The systemically available fraction of a drug.
Day of treatment to end of follow-up period (1, 2 or 4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Longevity Biotech Australia Pty Ltd (subsidiary)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

June 10, 2024

First Submitted That Met QC Criteria

June 13, 2024

First Posted (Actual)

June 20, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2026

Last Update Submitted That Met QC Criteria

August 20, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LBT-3627-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe