None
Conditions
Interventions
Multiple Dosing Study - Dose Group 2- experimental group:For 5 consecutive days, received an intravenous infusion of 500mg coenzyme I daily
Single Dose Administration Study - Dose Group 1- control group:received placebo
Baseline level exploration group:NA
Single Dose Administration Study - Dose Group 1- experimental group: 50mg of coenzyme I intravenously
Single Dose Administration Study - Dose Group 2- experimental group:received intravenous coenzyme I 100mg
Single Dose Administration Study - Dose Group 3- experimental group:received 200mg of coenzyme I intravenously
Single Dose Administration Study - Dose Group 4- experimental group:received intravenous coenzyme I 400mg
Single Dose Administration Study - Dose Group 5- experimental group:received intravenous coenzyme I 600mg
Single Dose Administration Study - Dose Group 6- experimental group:received intravenous coenzyme I infusion of 800mg
Multiple Dosing Study - Dose Group 1- experimental group:For 5 consecutive days, received a daily intravenous infusion of coenzyme I 200mg
Single Dose Administration Study - Dose Group 2- control group:received placebo
Single Dose Administration Study - Dose Group 3- control group:received placebo
Single Dose Administration Study - Dose Group 4- control group:received placebo
Single Dose Administration Study - Dose Group 5- control group:received placebo
Single Dose Administration Study - Dose Group 6- control group:received placebo
Multiple Dosing Study - Dose Group 1- control group:For 5 consecutive days, received placebo.
Multiple Dosing Study - Dose Group 2- control group:For 5 consecutive days, received placebo.
Sponsors
The First Affiliated Hospital of University of Science and Technology of China
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Healthy adult male or female subjects aged 18-60 years (including the threshold value, based on the time of signing the informed consent); 2. A body mass index (BMI) of 18 to 26 kg/m2 (including the cut-off), with a weight of not less than 50 kg for male subjects and not less than 45 kg for female subjects; 3. Eligible subjects (male or female) who are fertile must consent to the use of a medically approved non-drug contraceptive (such as an IUD or condom) during the trial period and for 3 months after the final dose; Women who are not fertile, are surgically sterilized (hysterectomy/bilateral salpingectomy/bilateral oophorectomy at least 6 weeks prior to screening) or have gone through menopause (defined as having gone 12 months without menstruation without other medical reasons); 4. Subjects fully understand the purpose, nature, method and possible adverse reactions of the test, voluntarily act as subjects, and sign informed consent; 5. Able to complete the test according to the requirements of the scheme.
Exclusion criteria
Exclusion criteria: 1. Persons with allergic constitution or suspected allergy to any component of the investigational drug; 2. Diseases or factors with clinical significance or other abnormal clinical significance, including but not limited to neurological, cardiovascular, blood, liver, kidney, gastrointestinal, respiratory, metabolic, endocrine, immune, skeletal system diseases or other factors; 3. Patients with abnormal results of physical examination, vital signs, heart color Doppler ultrasound, abdominal color Doppler ultrasound, laboratory examination (blood routine, blood biochemistry, urine routine, etc.), 12-lead electrocardiogram (ECG), chest anterior-lateral radiography, etc. during the screening period, and who were judged by researchers to be clinically significant. Included QTcF> 470 ms for female subjects and QTcF> 450 ms for male subjects (corrected by Fridericia's formula); Cardiac ultrasound ejection fraction upper limit of normal (ULN)] (subjects with simple fatty liver disease and normal liver function indicators can be included); 6. Patients with glomerular filtration rate (eGFR) < 90 mL/min/1.73m2 during the screening period; 7. Patients who have undergone major surgical operations or fractures in the 3 months prior to screening, or who are expected to require surgery during the trial period; 8. Patients with difficulty in venous blood collection judged by the researchers; 9. Had a history of drug abuse within 2 years prior to screening or had used drugs within 3 months prior to screening, or had tested positive for drug abuse during the screening period; 10. Those who smoked more than 5 cigarettes a day or habitually used nicotine-containing products in the 3 months before screening; 11. Persons who consumed more than 14 units of alcohol per week in the six months prior to screening (1 unit of alcohol =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine) or had consumed alcoholic products in the 48 hours prior to administration, or had a positive alcohol breath test during screening and/or baseline; 12. Use of any prescription drugs (including drugs that induce and inhibit liver drug enzymes), over-the-counter medicines, Chinese herbs, vitamins, or health supplements within 14 days prior to the start of the trial (or within 5 half-lives of the drug, whichever is older); 13. Food or pharmaceutical products containing high levels of NAD+, niacinamide riboside (NR) or NAM and niacin related ingredients, including dairy products, vitamin B3 and natural health products, in the 7 days prior to screening; 14. People who have taken food or drink (such as grapefruit, etc.) containing enzymes that
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerance/safety evaluation indicators: incidence and severity of adverse events (AE); SAE incidence and SUSAR; Laboratory tests (blood routine, blood biochemistry, myocardial enzyme spectrum, urine routine, coagulation function test, etc.); 12 lead ECG; Vital signs; Physical examination.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The PK parameters of SAD research mainly include: peak time (Tmax) of blood drug concentration of prototype and metabolites, Cmax, AUC0-t, AUC0-8, Elimination of half-life (t1/2, if applicable), etc;The PK parameters of MAD research mainly include: steady-state peak time (Tss, max) of the prototype and metabolites, steady-state maximum blood drug concentration (Css, max), steady-state trough concentration (Ctrough), steady-state average blood drug concentration (Css, avg), area under the steady-state drug concentration time curve (AUC0- t), t1/2 (if applicable), AUC0- t accumulation ratio (Rac-AUC), Cmax accumulation ratio (Rac-Cmax), cumulative excretion of urine (Ae), etc.; | — |
Countries
China
Contacts
Public ContactLikun Ma
The First Affiliated Hospital of University of Science and Technology of China
Outcome results
None listed