NCT04026321

Single-dose Escalation Study of SQ-001 Infusion to Characterize the PK Profiles of Major Sentinel Compounds in Healthy Adult Volunteers in US

A Double-blind, Single-dose Escalation Study of SQ-001 Infusion at a Single Center to Characterize the PK Profiles of Major Sentinel Compounds, Astragaloside IV, Calycosin 7-O-beta-glucopyranoside, and Lobetyolin in the Plasma of Healthy Adult Volunteers in the United States

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Livzon Pharmaceutical Group Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, double-blind, single-dose escalation study in healthy volunteers.

Detailed description

This is a single-center, double-blind, single-dose escalation study in healthy volunteers consisting of a 14-day Screening Period, 1-day Predose period, a 2-day Dosing and Evaluation Period, and a 5-day Follow-up Period, with a single Follow-up call scheduled on Day 7 ± 1. Subjects will be confined to the study site for up to 3 days (admitted on Day -1 and discharged on Day 2 or 3, depending on cohort) and will be monitored for adverse events (AEs) and dose limiting toxicities (DLT) during the Dosing, Evaluation and Follow-up Periods. Subjects will also be monitored for concomitant medications and use of rescue medications throughout the study. Subjects will be allocated 1:4 to receive an infusion of saline control (0.9% saline for injection) or Shenqi Fuzheng Injection(SQ-001) continuously for about 1-4 hours. SQ 001 will be administered by intravenous route at a rate of 3 mL/min to one of four final dosages: Cohort 1 (125 mL/day/person), Cohort 2 (250 mL/day/person), Cohort 3 (500 mL/day/person), and Cohort 4 (625 mL/day/person). Each cohort will be enrolled sequentially. Per cohort, three subjects will be dosed initially on Day 1 and observed for 24 hours. If there are no observed AEs that meet the criteria under Stopping Rules, the remaining 7 subjects/cohort will be dosed. Dose escalation to the next higher dose will be based on the observation of results in safety and degree of AEs from the previous cohort and discussion between the Investigator and Sponsor. A maximum 17 PK samples will be collected over the course of the study in each cohort. The PK sampling time points will be grouped as (a) pre-infusion; (b) intra-infusion; (c) completion of infusion; and (d) post-infusion. See Table 10 for plasma PK sampling times. The last PK sample will be collected 24 hours after the end of infusion.

Conditions

• Solid Tumor Refractory to Standard Therapy

Interventions

Type	Name	Description
DRUG	SQ001 125mL/day	SQ001 125mL/day will be administered by intravenous route at a rate of 3 mL/minute
DRUG	SQ001 250mL/day	SQ001 250mL/day will be administered by intravenous route at a rate of 3 mL/minute
DRUG	SQ001 500mL/day	SQ001 500mL/day will be administered by intravenous route at a rate of 3 mL/minute
DRUG	SQ001 625mL/day	SQ001 625mL/day will be administered by intravenous route at a rate of 3 mL/minute
DRUG	Saline 0.9%	Saline 0.9% will be administered by intravenous route at a rate of 3 mL/minute

Timeline

• Start date: 2018-10-03
• Primary completion: 2018-12-06
• Completion: 2018-12-11
• First posted: 2019-07-19
• Last updated: 2019-07-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study