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

NCT04026321 | Completed Phase 1 FDA Drug

• 1 other identifier: LV-SQ001-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Solid Tumor Refractory to Standard Therapy

Outcome Measures

Primary Outcomes (6)

• The maximum observed concentrations (Cmax)(ng/mL)

  To compare the Cmax of 3 major representative (sentinel) compounds astragaloside IV, calycosin 7-O-β-glucopyranoside, and lobetyolin in different experimental arms

  On 1 and 2 days (dosing day and the following evaluation day)

• Time to reach Cmax (Tmax)(h)

  To compare the Tmax of 3 major representative (sentinel) compounds astragaloside IV, calycosin 7-O-β-glucopyranoside, and lobetyolin in different experimental arms

  On 1 and 2 days (dosing day and the following evaluation day)

• Area under the concentration-time curve (AUC)(ng·h/mL)

  To compare the AUC of 3 major representative (sentinel) compounds astragaloside IV, calycosin 7-O-β-glucopyranoside, and lobetyolin in different experimental arms

  On 1 and 2 days (dosing day and the following evaluation day)

• Elimination half-life (T1/2)(h)

  To compare the Cmax of 3 major representative (sentinel) compounds astragaloside IV, calycosin 7-O-β-glucopyranoside, and lobetyolin in different experimental arms

  On 1 and 2 days (dosing day and the following evaluation day)

• Apparent clearance (CL)(mL/min/kg)

  To compare the CL of 3 major representative (sentinel) compounds astragaloside IV, calycosin 7-O-β-glucopyranoside, and lobetyolinin different experimental arms

  On 1 and 2 days (dosing day and the following evaluation day)

• Volume of distribution at steady state (Vdss)(L/kg)

  To compare the Vdss of 3 major representative (sentinel) compounds astragaloside IV, calycosin 7-O-β-glucopyranoside, and lobetyolinin different experimental arms

  On 1 and 2 days (dosing day and the following evaluation day)

Secondary Outcomes (3)

• Incidence of treatment-related adverse events

  From predose to up 5 days following the dosing and evaluation period

• Frequency of treatment-related adverse events

  From predose to up to 5 days following the dosing and evaluation period

• Grade of treatment-related adverse events

  From predose to up to 5 days following the dosing and evaluation period

Study Arms (5)

SQ-001 125mL/day

EXPERIMENTAL

Drug: SQ001 125mL/day

SQ-001 250mL/day

EXPERIMENTAL

Drug: SQ001 250mL/day

SQ-001 500mL/day

EXPERIMENTAL

Drug: SQ001 500mL/day

SQ-001 625mL/day

EXPERIMENTAL

Drug: SQ001 625mL/day

saline(0.9% NaCl injection)

PLACEBO COMPARATOR

Drug: Saline 0.9%

Interventions

SQ001 125mL/day DRUG

SQ001 125mL/day will be administered by intravenous route at a rate of 3 mL/minute

SQ-001 125mL/day

SQ001 250mL/day DRUG

SQ001 250mL/day will be administered by intravenous route at a rate of 3 mL/minute

SQ-001 250mL/day

SQ001 500mL/day DRUG

SQ001 500mL/day will be administered by intravenous route at a rate of 3 mL/minute

SQ-001 500mL/day

SQ001 625mL/day DRUG

SQ001 625mL/day will be administered by intravenous route at a rate of 3 mL/minute

SQ-001 625mL/day

Saline 0.9% DRUG

Saline 0.9% will be administered by intravenous route at a rate of 3 mL/minute

saline(0.9% NaCl injection)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be medically documented as healthy at the time of screening as determined by their medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests, unless the Investigator considers an abnormality to be clinically irrelevant.
• Subjects must be within 18 to 65 years old and not currently using tobacco products.
• Subjects must have a BMI within 18 to 32 kg/m2.
• Females
• Surgically sterilized (e.g., hysterectomy or bilateral oophorectomy) for at least 6 months prior to screening or postmenopausal (postmenopausal women must have no menstrual bleeding for at least 1 year prior to screening and menopause will be confirmed by a plasma FSH level of \>30 IU/L) or
• Women of child-bearing potential must be non-lactating and agree to use a highly effective acceptable form of birth control such as surgical sterilization (e.g., tubal ligation), or total abstinence from sexual intercourse with the opposite sex, or established hormonal birth control (e.g. oral, implant or injection) plus a barrier method, or a double barrier method (e.g. intrauterine device plus condom or spermicidal gel plus condom or diaphragm plus condom) from 14 days prior to dosing until 30 days after dosing.
• Women with a negative serum pregnancy test (βhCG assay) at screening and at Day -1 (urine)
• For non-sexually active females, abstinence may be regarded as an adequate method of birth control, but if the subject becomes sexually active during the study, she must use adequate birth control as defined above for the remainder of the study.
• Males Must be willing to use highly effective forms of acceptable birth control (e.g., vasectomy, total abstinence from sexual intercourse with the opposite sex, sexual intercourse with a woman who is not of childbearing potential) from Day 1 dosing to Day 90 after dose.
• Subjects must be able to comply with the study and follow-up procedures.
• Subjects must provide a signed informed consent to participate in the study.
• Subjects must not have participated in any clinical trial within 30 days.

You may not qualify if:

• Any condition preventing reliable phlebotomy or infusion from the cubital fossa.
• Documented history of clinically significant unstable medical illness.
• History of clinically significant drug, food, or environmental allergy.
• Subjects with any uncontrolled medical condition deemed clinically significant by an Investigator.
• Clinically significant safety laboratory, 12-lead ECG, or vital sign abnormalities during screening or Day -1 that would place the subject at undue risk based on the Investigator's opinion, including but not limited to:
• History of cardiac conditions that might give a higher risk of an increase in heart rate
• Fridericia's corrected QT interval (QTcF) interval of \>450 msec on 12-lead ECG
• Alanine aminotransferase (ALT) \>1.2 × upper limit of normal (ULN), aspartate aminotransferase (AST) \>1.2 × ULN
• Blood urea nitrogen (BUN) or serum creatinine \>1.2 × ULN
• Subjects who are positive for HIV, HBV, and/or HCV.
• Subjects who have used prescription drugs, over-the-counter drugs, or herbal remedies within 14 days before Day 1 of study medication dosing.
• Women who are pregnant or breast feeding.
• Subjects who participated in a clinical trial within 30 days prior to Day 1 study medication dosing.
• Subjects with any condition that, in the judgment of the Principal Investigator, would place a subject at undue risk, or potentially compromise the results or interpretation of the study.

Sponsors & Collaborators

• Livzon Pharmaceutical Group Inc.: lead
• Palm Beach CRO: collaborator
• Keystone Bioanalytical, Inc.: collaborator

Study Sites (1)

Clinical Pharmacology of Miami, Inc.

Miami, Florida, 33014-3616, United States

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Maria I. Bermudez, MD.CPI

  Clinical Pharmacology of Miami, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2019
• First Posted: July 19, 2019
• Study Start: October 3, 2018
• Primary Completion: December 6, 2018
• Study Completion: December 11, 2018
• Last Updated: July 19, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)