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anle138b

Phase 1

Parkinson Disease | Small molecule | Other |Catalent, Inc.|Last Updated: Mar 22, 2023

Development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Dec 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment70

FDA Designations

No designations recorded

Clinical trial landscape

anle138b · 2 trials · 2 indications

Phase 1 2
NCT04685265A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of anle138b in Parkinson's DiseaseParkinson Disease
COMPLETED70 Analytics
NCT04208152A First-in-Human Study of Single and Multiple Doses of anle138b in Healthy SubjectsHealthy Volunteers
COMPLETED68 Analytics
PHASE1COMPLETED
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of anle138b in Parkinson's Disease
Parkinson Disease
NCT0468526570
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PHASE1COMPLETED
A First-in-Human Study of Single and Multiple Doses of anle138b in Healthy Subjects
Healthy Volunteers
NCT0420815268
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Study Endpoints

Primary Endpoints

Incidence of treatment-emergent adverse events in PD patients with multiple ascending doses of anle138b taken in the fasted state (cohorts A-C + D).
Day 1 to day 14-16: cohorts A-C; day 1 to week 6 post dosing: cohort D

Adverse events

Incidence of treatment-emergent adverse events in PD patients with multiple ascending doses of anle138b taken in the fed state (Cohorts A and B).
From fed dosing (day 9) to day 12-14

Adverse events

Incidence of treatment-emergent changes in vital signs in PD patients with multiple ascending doses of anle138b taken in the fasted state (cohorts A-C + D).
Day 1 to week 1 post dosing: cohorts A-C; day 1 to week 6 post dosing: cohort D

Blood pressure

Incidence of treatment-emergent changes in vital signs in PD patients with multiple ascending doses of anle138b taken in the fed state (Cohorts A and B).
From fed dosing to 1 week post dosing

Blood pressure

Incidence of treatment-emergent ECG changes in PD patients with multiple ascending doses of anle138b taken in the fasted state (cohorts A-C + D).
Day 1 to week 1 post dosing: cohorts A-C; day 1 to week 6 post dosing: cohort D

Electrocardiogram (ECG) parameters including QT interval corrected for heart rate using Fridericia's formula (QTcF)

Incidence of treatment-emergent ECG changes in PD patients with multiple ascending doses of anle138b taken in the fed state (Cohorts A and B).
From fed dosing to 1 week post dosing

Electrocardiogram (ECG) parameters including QT interval corrected for heart rate using Fridericia's formula (QTcF)

Incidence of treatment-emergent changes in physical examination in PD patients with multiple ascending doses of anle138b taken in the fasted state (cohorts A-C + D).
Day 1 to week 1 post dosing: cohorts A-C; day 1 to week 6 post dosing: cohort D

Physical examination findings

Incidence of treatment-emergent changes in physical examination in PD patients with multiple ascending doses of anle138b taken in fed state (Cohorts A and B).
From fed dosing to 1 week post dosing

Physical examination findings

Incidence of treatment-emergent changes in clinical laboratory parameters in PD patients with multiple ascending doses of anle138b taken in the fasted state (cohorts A-C + D).
Day 1 to day 8

Clinical laboratory Tests: Hematology

Incidence of treatment-emergent changes in clinical laboratory parameters in PD patients with multiple ascending doses of anle138b taken in fed state (Cohorts A and B).
From fed dosing to 24 hours post dosing

Clinical laboratory Tests: Hematology

Incidence of treatment-emergent adverse events in PD patients with multiple ascending doses of anle138b taken 28 days in the non-fasted state (cohort E).
Day 1 to week 6 post dosing

Adverse events

Incidence of treatment-emergent changes in vital signs in PD patients with multiple ascending doses of anle138b taken 28 days in the non-fasted state (cohort E).
Day 1 to week 6 post dosing

Blood pressure

Incidence of treatment-emergent changes in physical examination in PD patients with multiple ascending doses of anle138b taken 28 days in the non-fasted state (cohort E).
Day 1 to week 6 post dosing

Physical examination findings

Incidence of treatment-emergent changes in clinical laboratory parameters in PD patients with multiple ascending doses of anle138b taken 28 days in the non-fasted state (cohort E).
Day 1 to 24 hours post dosing

Clinical laboratory Tests: Hematology

Incidence of treatment-emergent adverse events in healthy volunteers with single ascending doses of anle138b (Part 1)
Day 1 to day 30 post dose

Adverse events (AEs)

Incidence of treatment-emergent changes in clinical laboratory parameters in healthy volunteers with single ascending doses of anle138b (Part 1)
Day 1 to day 7 post dose

clinical laboratory tests including hematology and clinical chemistry including renal function tests, hepatic enzymes, electrolytes and creatine kinase

Incidence of treatment-emergent changes in vital signs in healthy volunteers with single ascending doses of anle138b (Part 1)
Day 1 to day 7 post dose

Blood pressure, heart rate, oral temperature

Incidence of treatment-emergent ECG changes in healthy volunteers with single ascending doses of anle138b (Part 1)
Day 1 to day 7 post dose

Electrocardiogram (ECG) parameters including QT interval corrected for heart rate using Fridericia's formula (QTcF)

Incidence of treatment-emergent changes in physical examination in healthy volunteers with single ascending doses of anle138b (Part 1)
Day 1 to day 7 post dose

physical examination findings

Incidence of treatment-emergent adverse events in healthy volunteers with multiple ascending doses of anle138b (Part 2)
Day 1 to day 30 post dose

Adverse events (AEs)

Incidence of treatment-emergent changes in clinical laboratory parameters in healthy volunteers with multiple ascending doses of anle138b (Part 2)
Day 1 to day 7 post dose

clinical laboratory tests including hematology and clinical chemistry including renal function tests, hepatic enzymes, electrolytes and creatine kinase

Incidence of treatment-emergent changes in vital signs in healthy volunteers with multiple ascending doses of anle138b (Part 2)
Day 1 to day 7 post dose

Blood pressure, heart rate, oral temperature

Incidence of treatment-emergent ECG changes in healthy volunteers with multiple ascending doses of anle138b (Part 2)
Day 1 to day 7 post dose

Electrocardiogram (ECG) parameters including QT interval corrected for heart rate using Fridericia's formula (QTcF)

Incidence of treatment-emergent changes in physical examination in healthy volunteers with multiple ascending doses of anle138b (Part 2)
Day 1 to day 7 post dose

physical examination findings

Incidence of treatment-emergent adverse events in healthy volunteers with a single dose of anle138b both the fasted and fed state (Part 3)
Day 1 to day 30 post dose.

Adverse events (AEs)

Incidence of treatment-emergent changes in clinical laboratory parameters in healthy volunteers with a single dose of anle138b both in the fasted and in the fed state (Part 3)
Day 1 to day 7 post dose

clinical laboratory tests including hematology and clinical chemistry including renal function tests, hepatic enzymes, electrolytes and creatine kinase

Incidence of treatment-emergent changes in vital signs in healthy volunteers with a single dose of anle138b both in the fasted and in the fed state (Part 3)
Day 1 to day 7 post dose

Blood pressure, heart rate, oral temperature

Incidence of treatment-emergent ECG changes in healthy volunteers with a single dose of anle138b both in the fasted and in the fed state (Part 3)
Day 1 to day 7 post dose

Electrocardiogram (ECG) parameters including QT interval corrected for heart rate using Fridericia's formula (QTcF)

Incidence of treatment-emergent changes in physical examination in healthy volunteers with single ascending doses of anle138b both in the fasted and in the fed state (Part 3)
Day 1 to day 7 post dose

physical examination findings

Secondary Endpoints

Oral pharmacokinetics (PK) of multiple ascending doses of anle138b in PD patients taken in the fasted state (cohorts A-C + D).
Day 1 to day 9
Oral pharmacokinetics (PK) of multiple ascending doses of anle138b in PD patients taken in the fasted state (cohort B).
Day 1 to day 9
Oral pharmacokinetics (PK) of multiple ascending doses of anle138b in PD patients taken in the fed state (Cohorts A and B).
From fed dosing to 48 hours post dosing.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
anle138bACTIVE_COMPARATOR150 mg and higher dosage
PlaceboPLACEBO_COMPARATORMatching placebo dosage

Interventions

NameTypeDescription
anle138bDRUGcapsule containing excipient and anle138b
PlaceboDRUGmatching placebo capsule containing excipient
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Eligibility Criteria

Age Range40 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Males and females with a diagnosis of idiopathic PD as defined by the Movement Disorders Society criteria (either fulfilling criteria for "Clinically Established PD" or for "Clinically Probable PD"). * Body mass index (BMI) 18.5 to 35.0 kg/m2 or 18.5 to \<40.0 kg/m2 (Cohorts D...

Countries:United Kingdom
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Competitive Landscape -Parkinson's Disease 58 trials (matched to "Parkinson Disease")

Top 12 of 19 competitors

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Supernus Pharmaceuticals, Inc.SUPN2PHASE3Onapgo (SPN-830)
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AC Immune SAACIU2PHASE2ACI-7104.056
Gain Therapeutics, Inc.GANX2PHASE2GT-02287
Eli Lilly and CompanyLLY3PHASE1LY3884961, LY4006896, LY3962681
Annovis Bio IncANVS1PHASE2Buntanetap
Regeneron Pharmaceuticals, Inc.REGN2PHASE1ALN-SNCA
MeiraGTx Holdings PlcMGTX1PHASE1AAV-GAD
AgeX Therapeutics, Inc.SER1PHASE1SER-252
Ardelyx, Inc.ARDX1PHASE2Tenapanor
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