Parkinson DiseasePhase 1NCT06466525
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.
A Phase 1 study testing LBT-3627 in people with Parkinson Disease, run by Longevity Biotech Australia Pty Ltd (subsidiary) at 3 sites in Australia.
Trial summary
Phase I a/b SAD/MAD study to evaluate safety and tolerability of LBT-3627 in both healthy volunteers and Parkinson's patients. Read more about this study
- Who is it for?
- Ages 30 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- LBT-3627
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 3 sitesAustralia
- Study dates
- 16 Jul 2024to Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites, 2 recruiting
- Recruiting
Alfred Hospital
Melbourne, Victoria, 3004
Beth Sutherland, +61 0487 531 448, B.Sutherland@alfred.org.au
- Recruiting
Monash Medical Center
Melbourne, Victoria, 3168
May Ho, +61 03 9594 3051, wing.ho@monashhealth.org
- Active, not recruiting
Nucleus Networks
Melbourne, Victoria
About this study
Phase I a/b SAD/MAD study to evaluate safety and tolerability of LBT-3627 in both healthy volunteers and Parkinson's patients.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- LBT-3627, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBT-3627Drug
Synthetic peptide
PlaceboDrug
Vehicle
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers - SAD | Experimental | Single dose of LBT-3627 administered to healthy volunteers Receives: Drug: LBT-3627; Drug: Placebo |
| Parkinson's disease patients - SAD | Experimental | Single dose of LBT-3627 administered to Parkinson's disease patients Receives: Drug: LBT-3627; Drug: Placebo |
| Parkinson's disease patients - MAD | Experimental | Multiple doses of LBT-3627 administered to Parkinson's disease patients Receives: Drug: LBT-3627; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, nature, and severity of adverse events [Safety and Tolerability]
Measured: Day of treatment to end of follow-up period (1, 2 or 4 weeks)
Secondary outcomes (8)
Maximum Plasma Concentration [Cmax]
The peak plasma concentration of a drug after administration.
Measured: 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.
Measured: Day of treatment to end of follow-up period (1, 2 or 4 weeks)
Time to reach Cmax [Tmax]
Time required to reach Cmax.
Measured: 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).
Measured: 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
Measured: 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).
Measured: 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.
Measured: Day of treatment to end of follow-up period (1, 2 or 4 weeks)
Bioavailability [f]
The systemically available fraction of a drug.
Measured: Day of treatment to end of follow-up period (1, 2 or 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start16 Jul 2024
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Placebo controlled, double blind, SAD and MAD dose escalation
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Longevity Biotech Australia Pty Ltd (subsidiary)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466525
- Sponsor's protocol ID
- LBT-3627-101
- Status last verified
- Sep 2026
- First submitted
- 10 Jun 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06466525
- Acronym / sponsor ID
- LBT-3627-101
- Conditions
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Longevity Biotech Australia Pty Ltd (subsidiary)Industry (pharma, biotech, devices)
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 20 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Placebo controlled, double blind, SAD and MAD dose escalation
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers - SAD | Experimental | Drug: LBT-3627, Drug: PlaceboSingle dose of LBT-3627 administered to healthy volunteers |
| Parkinson's disease patients - SAD | Experimental | Drug: LBT-3627, Drug: PlaceboSingle dose of LBT-3627 administered to Parkinson's disease patients |
| Parkinson's disease patients - MAD | Experimental | Drug: LBT-3627, Drug: PlaceboMultiple doses of LBT-3627 administered to Parkinson's disease patients |
Who may qualify
- Ages
- 30 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LBT-3627Synthetic peptide | Drug | Healthy Volunteers - SAD, Parkinson's disease patients - MAD, Parkinson's disease patients - SAD |
| PlaceboVehicle | Drug | Healthy Volunteers - SAD, Parkinson's disease patients - MAD, Parkinson's disease patients - SAD |
Primary outcome
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)
8 secondary outcomes
Maximum Plasma Concentration [Cmax]
Time frame: 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)
Time to reach Cmax [Tmax]
Time frame: 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)
Concentration [C]
Time frame: 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)
Clearance [CL]
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Michael J. Fox Trial FinderLink provided by the sponsor.
- Shake It Up Trial OverviewLink provided by the sponsor.
- Alfred Health Clinical Trial DetailsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LBT-3627 in people with Parkinson Disease, run by Longevity Biotech Australia Pty Ltd (subsidiary) at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly Bertram, MD (+61 0487 531 448, k.bertram@alfred.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.