MedTrace Logo

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

NCT04026321 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-07-19

No results posted yet for this study

Summary

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

Conditions

  • Solid Tumor Refractory to Standard Therapy

Interventions

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

Sponsors & Collaborators

  • Palm Beach CRO

    collaborator UNKNOWN

  • Keystone Bioanalytical, Inc.

    collaborator UNKNOWN

  • Livzon Pharmaceutical Group Inc.

    lead INDUSTRY

Principal Investigators

  • Maria I. Bermudez, MD.CPI · Clinical Pharmacology of Miami, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-03
Primary Completion
2018-12-06
Completion
2018-12-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04026321 on ClinicalTrials.gov