NCT07457008

Tolerability & Pharmacokinetics of Ginkgolide B Injection: Single- and Multiple-Ascending Doses in Healthy Subjects

Tolerability and Pharmacokinetics of Ginkgolide B Injection Following Single- and Multiple-Ascending Doses in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: West China Second University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety and tolerability of multiple intravenous infusions of Ginkgolide B Injection in healthy Chinese participants, as well as to assess the pharmacokinetic (PK) characteristics following single and multiple doses.

Detailed description

This was a single-center, randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation study. A total of three dose groups (low, medium, and high) were planned for the multiple-dose dose-escalation safety and tolerability study, as well as the single- and multiple-dose PK study. The dose groups were 10 mg, 20 mg, and 30 mg, with a total of 36 subjects across the three groups (12 per group).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	The 10mg dose group	The 10mg dose group was prepared with 375ml of 0.9% sodium chloride solution to form different dosage groups, an
DRUG	The 20mg dose group	The 20mg dose group was prepared with 375ml of 0.9% sodium chloride solution, and was instilled at the same rate of 50 drops/min for 7 consecutive days.
DRUG	The 30mg dose group	The 30mg dose group was prepared with 375ml of 0.9% sodium chloride solution, and was instilled at the same rate of 50 drops/min for 7 consecutive days.
OTHER	The Placebo group	The Placebo group was prepared with 375ml of 0.9% sodium chloride solution, and was instilled at the same rate of 50 drops/min for 7 consecutive days.

Timeline

• Start date: 2021-07-01
• Primary completion: 2021-09-03
• Completion: 2021-09-09
• First posted: 2026-03-09
• Last updated: 2026-03-09

Locations

1 site across 1 country: China