Alzheimers disease mitochondrial myopathy
Conditions
Interventions
SAD Cohort 1:A single dose of IPG8294 or placebo oral administered dose 10 mg, with 6 receiving IPG8294 and 2 receiving the placebo
SAD Cohort 2:A single dose of IPG8294 or placebo oral administered dose 25 mg, with 6 receiving IPG8294 and 2 receiving the placebo
SAD Cohort 3:A single dose of IPG8294 or placebo oral administered dose 50 mg, with 6 receiving IPG8294 and 2 receiving the placebo
SAD Cohort 4:A single dose of IPG8294 or placebo oral administered dose 100 mg, with 6 receiving IPG8294 and 2 receiving the placebo
MD Cohort M1:Administer once daily for 14 consecutive days. Take 100 mg of IPG8294 orally or placebo. Among them, 2 will receive placebo and the other 6 will receive IPG8294
Part C Cohort FE:In Cycle 1, subjects in the fasting-postprandial group will receive 100 mg IPG8294 orally under fasting conditions, and subjects in the postprandial-fasting group will receive 100 mg
Sponsors
Zhejiang Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Healthy Chinese subjects aged 18–50 years (inclusive of both limits), male and female.?? 2.?? Subjects shall undergo physical examination, vital signs examination, 12-lead electrocardiogram, chest radiography (posteroanterior and lateral views), and laboratory tests (blood routine, blood biochemistry, coagulation function, urinalysis, four infectious disease tests, etc.). Those determined by the investigator to have normal results or abnormal results without clinical significance are eligible.?? 3.?? Male body weight >=50.0 kg, female body weight >=45.0 kg, with a body mass index (BMI) between 19.0–26.0 (inclusive). Calculation formula: BMI = weight (kg) / height² (m²).?? 4.?? Female subjects must be non-pregnant and non-lactating.?? 5.?? Subjects must agree to use effective contraceptive methods (see appendix for details) and refrain from sperm/egg donation for 2 weeks prior to screening until 6 months after trial completion. No pregnancy plans during this period.?? 6.?? Subjects must sign the study Informed Consent Form before enrollment, fully understand the study details, procedures, and potential adverse reactions.?? ??Only subjects who meet all the above criteria will be eligible for inclusion.
Exclusion criteria
Exclusion criteria: 1. History of severe cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, dermatological, neurological, or psychiatric disorders, with current clinical significance as judged by the investigator.?? 2.?? Male QTcF>450 ms or female QTcF>470 ms?? (QTcF calculation formula provided in the appendix). 3.?? History of recurrent headaches and/or migraines, or recurrent nausea and/or vomiting.?? 4.?? Donated blood or experienced significant blood loss >=400 mL (excluding normal menstrual bleeding in females) within 3 months prior to screening, or plans to donate blood during the trial or within 1 month after trial completion.?? 5.?? History of orthostatic hypotension.?? 6.?? Difficulty swallowing.?? 7.?? History of gastrointestinal disorders (Including chronic or active upper gastrointestinal diseases such as: esophageal diseases, gastritis, duodenal diseases, gastrointestinal ulcers, etc.) affecting drug absorption.?? 8.?? Special dietary requirements or inability to comply with the trial’s standardized diet.?? 9.?? Lactose intolerance (history of diarrhea after consuming milk).?? 10.?? Underwent surgery within 3 months prior to screening, plans to undergo surgery during the trial, or has undergone surgery affecting drug absorption, distribution, metabolism, or excretion.?? 11.?? Allergy to any component of the investigational product or history of hypersensitivity (e.g., to drugs, foods).?? 12.?? History of drug allergies or diagnosed allergic diseases.?? 13.?? History of drug abuse or substance misuse.?? 14.?? Alcohol consumption >14 units/week (1 unit ˜ 360 mL beer, 45 mL spirits [40% alcohol], or 150 mL wine) within 3 months prior to screening, or inability to abstain during the trial.?? 15.?? Smoked >5 cigarettes/day prior to screening, or inability to quit tobacco products (e.g., cigarettes, nicotine lozenges, gum) during the trial.?? 16.?? Consumed excessive caffeine-containing beverages (tea, coffee, etc.) >8 cups/day (1 cup = 250 mL) prior to screening.?? 17.?? Used any prescription/over-the-counter medications, supplements, and/or herbal products within 14 days prior to screening.?? 18.?? Used hepatic enzyme-inducing/inhibiting drugs, gastrointestinal environment-modifying drugs within 30 days prior to screening.?? 19.?? Consumed citrus fruits (e.g., grapefruit, oranges) or their juices within 5 days prior to screening.?? 20.?? Unable to abstain from citrus fruits/juices during the trial.?? 21.?? Received vaccines or biologics (antibodies/derivatives) within 4 months prior to screening or plans to receive them during the trial.?? 22.?? Participated in another clinical trial involving investigational drugs within 3 months prior to screening, or non-compliant participation (e.g., proxy attendance).?? 23.???? Positive drug screen?? (opioids, THC [cannabis], amphetamines [methamphetamine], MDMA [ecstasy], ketamine ). 24.?? Alcohol breath test result >0 mg/100 mL.?? 25.?? Female subjects engaged in unprotected sexual intercourse within 2 weeks prior to screening.?? 26.?? History of difficult venipuncture, needle phobia, or vasovagal reactions.?? 27.?? Development of acute illness before screening.?? 28.?? Other conditions deemed unsuitable for enrollment by the investigator.? Subjects meeting any of the above criteria will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability Parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic Evaluation Parameters (SAD): Cmax, Tmax, t1/2, AUC0-t, AUC0-inf, CL/F;Biomarkers Assessment;Pharmacokinetic Evaluation Parameters (Food effect): Cmax, Tmax, t1/2, AUC0-t, AUC0-inf, CL/F;PK evaluation indicators (MD): Css, max, t1/2, Tss, max, AUC0- t, CLss/F, accumulation index Rac (AUC), Rac (Cmax);; | — |
Countries
China
Contacts
Public ContactJun Chen; Wanggang Zhang
Zhejiang Hospital
Outcome results
None listed