NCT07630545招募中1 期
A Multi-part, Adaptive Phase 1, First Time in Human Study in Healthy Volunteers to Assess Safety, Tolerability and Pharmacokinetics (PK) Following Single Ascending Dose (SAD) and Multiple Ascending Doses (MAD) of MTX325, Including Option to Assess: a Single Dose in Elderly Participants; Multiple Doses in Patients With Parkinson's Disease (PD); Central Nervous System (CNS) Penetration, Biodistribution, and Biomarkers; and the Effect of Food on PK.
Mission Therapeutics21 个研究点 分布在 4 个国家目标入组 106 人开始时间: 2023年11月30日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 106
- 试验地点
- 21
研究概览
简要总结
The goal of this trial is to learn if MTX325 can be developed as a potential disease-modifying treatment for Parkinson's Disease. Parts 1-4 complete, Part 5 (multiple doses in patients with Parkinson's Disease) in progress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PART 5 - Currently recruiting in Parkinson's Disease Patients
- •Inclusion Criteria
- •Male and female participants aged ≥ 40 to ≤ 75 years.
- •Male or female participants. Female participants of childbearing potential must be willing to use highly effective forms of contraception (refer to Section 9.7.1 for details on highly effective methods of contraception and definitions of women of childbearing potential and of fertile men):
- •Body mass index (BMI) between 18 and 34.0 kg/m2, inclusive.
- •If being treated with selective serotonin reuptake inhibitors (SSRIs) for anxiety/ depression, must be on a stable dose for 60 days prior to Day -1 and must remain on that dose for the remainder of the study.
- •Must have had other causes of Parkinsonism excluded
- •No clinically significant history of previous allergy/ sensitivity to MTX325 or any of the excipients contained within the IMP.
- •Participant with a negative urinary drugs of abuse (DOA) screen (excluding alcohol).
- •Participant with negative human immunodeficiency virus (HIV), hepatitis B surface antigen [HbsAg]) and hepatitis C virus antibody (HCV Ab) test results at Screening.
- •No history of torsade de pointes or long QT syndrome and no heart failure, hypokalaemia, or any other additional cardiac risk factors if judged clinically significant in the opinion of the Investigator.
- •No clinically significant abnormalities in vital signs during the screening period.
- •Able to perform all protocol assessments and comply with the study visit schedule.
- •Able and willing to provide informed consent.
- •Clinically established PD as per MDS Criteria[
- •Absence of dementia as shown by a baseline Montreal Cognitive Assessment (MoCA®)
排除标准
- •A clinically significant history of gastrointestinal disorders or any significant medical conditions that would be likely to influence IMP absorption, or evidence of clinically significant central nervous system, respiratory, cardiovascular or metabolic dysfunction or other significant medical conditions with potential to impact participant safety or hinder interpretation of study results.
- •Clinically significant neurologic disorder other than PD, including history of stroke within 12 months of Screening, seizure within 5 years of Screening, or head trauma with loss of consciousness within 6 months of Screening.
- •Those with known PD risk genes (per medical history).
- •Reside in a nursing home or assisted care facility.
- •No more than 2 PD related freezing episodes or falls in the past 6 months.
- •Any condition that may predispose participant to complications or technical difficulty with lumbar puncture, in the opinion of the Investigator.
- •Participants who have conditions that would preclude a lumbar puncture (LP), such as a local infection at the site
- •Participant who has a history of clinically significant hypersensitivity to local anaesthesia, or its derivatives used during CSF collection or to any medication used to prepare the area of LP.
- •Reports having experienced suicidal ideation (Type 4 on 5 on the Columbia-Suicide Severity Rating Scale [C-SSRS©]
- •Participants should not be in receipt of any known MATE2k substrates
- •Plan to receive or administration of rotigotine, catechol-o-methyltransferase (COMT) inhibitors (e.g., entacapone, tolcapone or opicapone), neuroleptics, venlafaxine, NMN, nicotinamide riboside or non-selective Monoamine oxidase [MAO] inhibitors within 7 days or 5 half-lives (whichever is longer) prior to first dose and during the study conduct.
- •Clinically significant abnormal test results for serum biochemistry, haematology, coagulation and/or urine analyses as determined within 45 days before first dose of IMP.
- •A clinically significant history of gastrointestinal disorder likely to influence IMP absorption.
- •Participant has any condition that, in the opinion of the investigator, is clinically significant and may put the participant at greater safety risk, influence response to study product, or interfere with study assessment.
- •Inability to communicate well with the Investigators.
- •Participation (dosed) in a NCE clinical study within the previous 3 months or five half lives
- •Donation of 450 mL or more blood within the 3 months before the first dose of IMP.
- •Female participants who are pregnant, breastfeeding or lactating.
- •Clinically significant abnormalities in 12-lead electrocardiogram (ECG)
- •Participants with recent COVID-19 infection without resolution of symptoms
- •Participants who have received a COVID-19 vaccine injection from the Screening visit up to first dose of IMP
- •A clinically significant history of drug or alcohol abuse within the past 2 years.
- •Currently prescribed treatment for Parkinson's Disease symptoms.
- •Any history of allergy/atopy including drug-induced allergy history of severe cutaneous adverse reaction or other type 4/delayed-type hypersensitivity.
- •Current or previous history of eosinophilia with either unknown cause, or where known, the inciting factor is not removed or avoided.
- •Previous history of Erythema Multiforme and/or identified current risk factor(s) for Erythema Multiforme
- •Participant has any contra-indication to PET or MRI as determined by screening procedures and PET and MRI safety questionnaires as conducted by the site.
- •Clinically significant history of previous allergy/ sensitivity to [18F] FDG.
- •Participants who have had previous exposure to ionizing radiation
- •Chronic kidney disease defined as glomerular filtration rate (GFR) 1.5 × the upper limit of normal (ULN) or ALT or AST >3 × ULN or if participant has Child-Pugh Class C cirrhosis or equivalent severe hepatic impairment.
- •Hepatic disease or altered liver function as defined by total bilirubin >1.5 × the upper limit of normal (ULN) or ALT or AST >3 × ULN or if participant has Child-Pugh Class C cirrhosis or equivalent severe hepatic impairment.
- •Patients with uncontrolled type I or type II diabetes (insulin or non-insulin dependent).
- •Current symptomatic Hay fever or any history of hay fever involving more than nose and eyes.
- •PART 1, 2 ,4 - COMPLETED
- •Inclusion Criteria:
- •Healthy male and female (Part 1-2 only) participant, aged ≥ 18 to ≤ 55 years.
- •Female participant of childbearing potential (Part 1-2 only)
- •Female participant of non-childbearing potential (Part 1-2 only).
- •Female participant (Part 1-2 only) with a negative pregnancy test at Screening visit.
- •Female participant of menopausal status (Part 1-2 only) confirmed by demonstrating at Screening that the serum level of the follicle stimulating hormone (FSH) falls within the respective pathology reference range.
- •Male participant (and partner of childbearing potential) willing to use a highly effective method of contraception
- •Participant with a body weight of at least 50.0 kg and body mass index (BMI) of 1832 kg/m
- •BMI = body weight (kg) / [height (m)]
- •No clinically significant history of previous allergy / sensitivity to MTX325 or any of the excipients contained within the IMP.
- •No clinically significant abnormal test results for serum biochemistry, haematology, coagulation
- •Participant with a negative urinary drugs of abuse (DOA) screen (including alcohol) test results, determined within 35 days (45 days Part 4 only) before first dose of IMP.
- •Participant with negative human immunodeficiency virus (HIV), hepatitis B surface antigen [HbsAg]) and hepatitis C virus antibody (HCV Ab) test results at Screening.
- •No clinically significant abnormalities in 12-lead electrocardiogram (ECG)
- •No clinically significant abnormalities in vital signs
- •Participant must be available to complete the study (including all follow-up visits).
- 另有 73 项未显示
研究组 & 干预措施
Parts 1 - 3, and 5
Placebo Comparator
MTX325 Placebo Capsules - 50mg. Parts 1-3 are SAD, MAD and Elderly cohorts. Matched strength placebo capsules in Part 5 (PD participants)
干预措施: Placebo (Other)
Part 4
Active Comparator
MTX325 Capsules - 20mg. Radiolabelled MTX325 solution for injection. This is a healthy volunteer PET study. Not placebo controlled.
干预措施: MTX325 (Drug)
Part 5
Active Comparator
MTX325 - 20 mg Capsules
干预措施: MTX325 (Drug)
Parts 1 - 4
Active Comparator
MTX325 Active Oral Capsules - 1.5mg - 100mg These 4 parts are SAD, MAD, Elderly and PET biodistribution.
干预措施: MTX325 (Drug)
研究者
研究点 (21)
Loading locations...
相似试验
招募中
1 期
A multi-part study to investigate MTX325 in healthy volunteers and patients with Parkinson's DiseaseParkinson's Disease2024-517310-15-00Mission Therapeutics Limited18
招募中
3 期
AMX0035 and Progressive Supranuclear Palsy2023-505893-14-00Amylyx Pharmaceuticals Inc.269
招募中
1 期
Single and Multiple Ascending Doses of NTX-253 in Healthy Participants and Participants With Stable SchizophreniaNCT07344948Neurosterix73
已完成
3 期
A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral Sclerosis2023-508511-23-00Amylyx Pharmaceuticals Inc.526
尚未招募
1 期
To investigate the safety and Tolerability of HCFX-072515 in Healthy VolunteersCTRI/2025/12/099819Himalaya Wellness Company (HWC)40