En todelt enkelt- og flerdoseforsøk av sikkerhet, tolerabilitet, farmakokinetikk og farmakodynamikk til LBT-3627 hos friske deltakere og hos deltakere med Parkinsons sykdom.
Phase I a/b SAD/MAD study to evaluate safety and tolerability of LBT-3627 in both healthy volunteers and Parkinson's patients.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Kelly Bertram, MD
- Telefonnummer: +61 0487 531 448
- E-post: k.bertram@alfred.org.au
Studiesteder
-
-
Victoria
-
Melbourne, Victoria, Australia, 3004
- Rekruttering
- Alfred Hospital
-
Ta kontakt med:
- Beth Sutherland
- Telefonnummer: +61 0487 531 448
- E-post: B.Sutherland@alfred.org.au
-
Melbourne, Victoria, Australia, 3168
- Rekruttering
- Monash Medical Center
-
Ta kontakt med:
- May Ho
- Telefonnummer: +61 03 9594 3051
- E-post: wing.ho@monashhealth.org
-
Melbourne, Victoria, Australia
- Aktiv, ikke rekrutterende
- Nucleus Networks
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Healthy Volunteers - SAD
Single dose of LBT-3627 administered to healthy volunteers |
Synthetic peptide Vehicle |
|
Eksperimentell: Parkinson's disease patients - SAD
Single dose of LBT-3627 administered to Parkinson's disease patients |
Synthetic peptide Vehicle |
|
Eksperimentell: Parkinson's disease patients - MAD
Multiple doses of LBT-3627 administered to Parkinson's disease patients |
Synthetic peptide Vehicle |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Forekomst, art og alvorlighetsgrad av uønskede hendelser [Sikkerhet og tolerabilitet]
Tidsramme: Behandlingsdag til slutten av oppfølgingsperioden (1, 2 eller 4 uker)
|
Behandlingsdag til slutten av oppfølgingsperioden (1, 2 eller 4 uker)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Maximum Plasma Concentration [Cmax]
Tidsramme: 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]
Tidsramme: 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]
Tidsramme: 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]
Tidsramme: 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]
Tidsramme: 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]
Tidsramme: 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]
Tidsramme: 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]
Tidsramme: 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)
|
Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- LBT-3627-101
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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