Solid Tumor Refractory to Standard Therapy Clinical Trial
Official title:
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
This is a single-center, double-blind, single-dose escalation study in healthy volunteers.
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.
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