Study on Tolerance, Pharmacokinetics and Drug Interaction of YK-1169 in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

December 20, 2021

Primary Completion Date

April 2, 2022

Study Completion Date

April 8, 2022

Conditions
Pharmacokinetics
Interventions
DRUG

Group 1:YK-1169

YK-1169 0.5g (containing cefepime 0.4g, avibactam 0.1g) single intravenous infusion for 2 hours

DRUG

Group 2:YK-1169/Placebo Injection

YK-1169 1.25g (containing cefepime 1.0g, avibactam 0.25g) / placebo single intravenous infusion for 2 hours

DRUG

Group 3:YK-1169/Placebo

On the first day, YK-1169 2.5 g (containing cefepime 2.0 g, avibactam 0.5g) was single intravenously infused for 2 h. On the third day, YK-1169 2.5 g (containing cefepime 2.0 g, avibactam 0.5g) was single intravenous infusion for 2 h, three times a day at 8-h intervals, until the morning dose on the tenth day

DRUG

Group 4:YK-1169/Placebo

On the first day, YK-1169 3.75 g (containing cefepime 3.0 g, avibactam 0.75g) was single intravenously infused for 2 h. On the third day, YK-1169 3.75 g (containing cefepime 3.0 g, avibactam 0.75g) was single intravenous infusion for 2 h, three times a day at 8-h intervals, until the morning dose on the tenth day

DRUG

Group 5:YK-1169/Placebo Injection

YK-1169 5.0g (containing cefepime 4.0g, avibactam 1.0g) / placebo single intravenous infusion for 2 hours

DRUG

Group 6:YK-1169/Cefepime hydrochloride for injection/Avibactam for injection

YK-1169 2.5g (containing cefepime 2.0g, avibactam 0.5g)/cefepime hydrochloride for injection 2.0g/avibactam for injection 0.5g, three-cycle three-cross single intravenous infusion for 2 hours

Trial Locations (1)

210000

辛玉霞, Nanjing

All Listed Sponsors
lead

Nanjing Yoko Biomedical Co., Ltd.

INDUSTRY

NCT05588531 - Study on Tolerance, Pharmacokinetics and Drug Interaction of YK-1169 in Healthy Volunteers | Biotech Hunter | Biotech Hunter