Solid Tumor Refractory to Standard TherapyPhase 1NCT04026321

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

A Phase 1 study testing SQ001 125mL/day, SQ001 250mL/day and SQ001 500mL/day in people with Solid Tumor Refractory to Standard Therapy, run by Livzon Pharmaceutical Group Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Solid Tumor Refractory to Standard Therapy
What is being tested?: SQ001 125mL/day, SQ001 250mL/day and SQ001 500mL/day
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 3 Oct 2018to 11 Dec 2018
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical Pharmacology of Miami, Inc.
Miami, Florida, 33014-3616

Other trials in United States

About this study

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.

Read the 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
Being tested: SQ001 125mL/day, SQ001 250mL/day, SQ001 500mL/day, SQ001 625mL/day, Saline 0.9%

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SQ001 125mL/dayDrug
SQ001 125mL/day will be administered by intravenous route at a rate of 3 mL/minute
SQ001 250mL/dayDrug
SQ001 250mL/day will be administered by intravenous route at a rate of 3 mL/minute
SQ001 500mL/dayDrug
SQ001 500mL/day will be administered by intravenous route at a rate of 3 mL/minute
SQ001 625mL/dayDrug
SQ001 625mL/day will be administered by intravenous route at a rate of 3 mL/minute
Saline 0.9%Drug
Saline 0.9% will be administered by intravenous route at a rate of 3 mL/minute

Study groups in NCT04026321
Study group	Role	What they receive
SQ-001 125mL/day	Experimental	Not described Receives: Drug: SQ001 125mL/day
SQ-001 250mL/day	Experimental	Not described Receives: Drug: SQ001 250mL/day
SQ-001 500mL/day	Experimental	Not described Receives: Drug: SQ001 500mL/day
SQ-001 625mL/day	Experimental	Not described Receives: Drug: SQ001 625mL/day
saline(0.9% NaCl injection)	Placebo comparator	Not described Receives: Drug: Saline 0.9%

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

Incidence of treatment-related adverse events
Incidence of treatment-related adverse events as assessed by CTCAE v4.03
Measured: From predose to up 5 days following the dosing and evaluation period
Frequency of treatment-related adverse events
Frequency of treatment-related adverse events as assessed by CTCAE v4.03
Measured: From predose to up to 5 days following the dosing and evaluation period
Grade of treatment-related adverse events
Grade of treatment-related adverse events as assessed by CTCAE v4.03
Measured: From predose to up to 5 days following the dosing and evaluation period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Oct 201811 Dec 2018

First posted19 Jul 2019
Study start3 Oct 2018
Primary completion6 Dec 2018
Study completion11 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid Tumor Refractory to Standard TherapyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04026321
Sponsor's protocol ID: LV-SQ001-01
Status last verified: Jul 2019
First submitted: 14 Jul 2019
Last updated: 19 Jul 2019
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
SI-B036-ST-101 in Advanced/Metastatic Solid Tumors
Locally Advanced /Metastatic Solid Tumors, Locally Advanced / Metastatic Solid Tumors
Active, not recruitingPhase 1
RNR Inhibitor COH29 in Treating Patients With Solid Tumors That Are Refractory to Standard Therapy or For Which No Standard Therapy Exists
Unspecified Adult Solid Tumor, Protocol Specific
Active, not recruitingPhase 1/2
Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (KL264-01)
Epithelial Ovarian Cancer, Gastric Adenocarcinoma
Active, not recruitingPhase 2
NP137 Clinical and Biological Activities Assessment in Patients With Advanced/Metastatic Solid Tumors Treated by Standard Anti PD-1/PD-L1 Immunotherapies
Advanced Solid Tumors, Metastatic Solid Tumors
RecruitingPhase 2
Trastuzumab Rezetecan in Advanced Solid Tumors Refractory to Standard Therapies
Urachal Cancer, Advanced Solid Tumor Cancer

All Solid Tumor Refractory to Standard Therapy trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04026321
Acronym / sponsor ID: LV-SQ001-01
Conditions: Solid Tumor Refractory to Standard Therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Livzon Pharmaceutical Group Inc.Industry (pharma, biotech, devices)
Collaborators: Palm Beach CRO, Keystone Bioanalytical, Inc.
Study start: 3 Oct 2018 (actual)
Primary completion: 6 Dec 2018 (actual)
Study completion: 11 Dec 2018 (actual)
First posted: 19 Jul 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
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%

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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
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.

Key exclusion criteria (14 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SQ001 125mL/daySQ001 125mL/day will be administered by intravenous route at a rate of 3 mL/minute	Drug	SQ-001 125mL/day
SQ001 250mL/daySQ001 250mL/day will be administered by intravenous route at a rate of 3 mL/minute	Drug	SQ-001 250mL/day
SQ001 500mL/daySQ001 500mL/day will be administered by intravenous route at a rate of 3 mL/minute	Drug	SQ-001 500mL/day
SQ001 625mL/daySQ001 625mL/day will be administered by intravenous route at a rate of 3 mL/minute	Drug	SQ-001 625mL/day
Saline 0.9%Saline 0.9% will be administered by intravenous route at a rate of 3 mL/minute	Drug	saline(0.9% NaCl injection)

Primary outcome

The maximum observed concentrations (Cmax)(ng/mL)
Time frame: On 1 and 2 days (dosing day and the following evaluation day)
To compare the Cmax of 3 major representative (sentinel) compounds astragaloside IV, calycosin 7-O-β-glucopyranoside, and lobetyolin in different experimental arms
Time to reach Cmax (Tmax)(h)
Time frame: On 1 and 2 days (dosing day and the following evaluation day)
To compare the Tmax of 3 major representative (sentinel) compounds astragaloside IV, calycosin 7-O-β-glucopyranoside, and lobetyolin in different experimental arms
Area under the concentration-time curve (AUC)(ng·h/mL)
Time frame: On 1 and 2 days (dosing day and the following evaluation day)
To compare the AUC of 3 major representative (sentinel) compounds astragaloside IV, calycosin 7-O-β-glucopyranoside, and lobetyolin in different experimental arms
Elimination half-life (T1/2)(h)
Time frame: On 1 and 2 days (dosing day and the following evaluation day)
To compare the Cmax of 3 major representative (sentinel) compounds astragaloside IV, calycosin 7-O-β-glucopyranoside, and lobetyolin in different experimental arms
Apparent clearance (CL)(mL/min/kg)
Time frame: On 1 and 2 days (dosing day and the following evaluation day)
To compare the CL of 3 major representative (sentinel) compounds astragaloside IV, calycosin 7-O-β-glucopyranoside, and lobetyolinin different experimental arms
Volume of distribution at steady state (Vdss)(L/kg)
Time frame: On 1 and 2 days (dosing day and the following evaluation day)
To compare the Vdss of 3 major representative (sentinel) compounds astragaloside IV, calycosin 7-O-β-glucopyranoside, and lobetyolinin different experimental arms

3 secondary outcomes

Incidence of treatment-related adverse events
Time frame: From predose to up 5 days following the dosing and evaluation period
Frequency of treatment-related adverse events
Time frame: From predose to up to 5 days following the dosing and evaluation period
Grade of treatment-related adverse events
Time frame: From predose to up to 5 days following the dosing and evaluation period

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
Individual participant dataSharing planned: No

Related trials for Solid Tumor Refractory to Standard Therapy

RecruitingPhase 1
SI-B036-ST-101 in Advanced/Metastatic Solid Tumors
Locally Advanced /Metastatic Solid Tumors, Locally Advanced / Metastatic Solid Tumors
Active, not recruitingPhase 1
RNR Inhibitor COH29 in Treating Patients With Solid Tumors That Are Refractory to Standard Therapy or For Which No Standard Therapy Exists
Unspecified Adult Solid Tumor, Protocol Specific
Active, not recruitingPhase 1/2
Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (KL264-01)
Epithelial Ovarian Cancer, Gastric Adenocarcinoma
Active, not recruitingPhase 2
NP137 Clinical and Biological Activities Assessment in Patients With Advanced/Metastatic Solid Tumors Treated by Standard Anti PD-1/PD-L1 Immunotherapies
Advanced Solid Tumors, Metastatic Solid Tumors
RecruitingPhase 2
Trastuzumab Rezetecan in Advanced Solid Tumors Refractory to Standard Therapies
Urachal Cancer, Advanced Solid Tumor Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Maria I. Bermudez, MD.CPI principal investigator

Clinical Pharmacology of Miami, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The maximum observed concentrations (Cmax)(ng/mL) (time frame: On 1 and 2 days (dosing day and the following evaluation day)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04026321.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2019.