NCT05588531

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Nanjing Yoko Biomedical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety and tolerability of multiple doses of YK-1169 in healthy subjects, the pharmacokinetic characteristics of multiple doses in healthy subjects, and the drug interaction between cefepime and avibactam.

Detailed description

A randomized, single-blind, placebo-controlled, dose-escalation, single-center clinical trial design was used. A total of 5 dose groups A1, A2, A3, A4 and A5 were set in the test, including A1 YK-1169 0.5g group (containing cefepime 0.4g and avibactam 0.1g), A2 YK-1169 1.25g group (containing cefepime 1.0g and avibactam 0.25g), A3 YK-1169 2.5g (containing cefepime 2.0g and avibactam 0.5g), A4 YK-1169 3.75g (containing cefepime 3.0g and avibactam 0.75g) and A5 YK-1169 5.0g (containing cefepime 4.0g and avibactam 1.0g). A single-center, randomized, open, three-period three-crossover 3 × 3 Latin square trial design was used. To study the effect of intravenous infusion of this product, cefepime for injection or avibactam for injection on the disposition process of the drug in the human body, so as to study whether there is a pharmacokinetic drug interaction in this product.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-12-20
• Primary completion: 2022-04-02
• Completion: 2022-04-08
• First posted: 2022-10-20
• Last updated: 2022-10-20

Locations

1 site across 1 country: China