A Study of SSS17 in Healthy Subjects

March 20, 2020 updated by: Shenyang Sunshine Pharmaceutical Co., LTD.

A Single Dose Escalation Study to Investigate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of SSS17 in Chinese Healthy Subject

This is a first-in-human, Phase 1, single-center, randomized, single-blind, placebo-controlled, single dose-escalation study to evaluate the safety, tolerability, PK, PD of SSS17 following oral administration in healthy subjects. Approximately 65 subjects (53 receiving active drug and 12 receiving placebo) will participate in this study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will enroll healthy volunteers from a single academic medical center in China. All participants will be informed about the study and potential risks and required to provide written informed consent prior to undergoing study-related procedures.

The improved Fibonacci dose escalation design will be implemented. The protocol specifies 10 mg, oral, one time for the first cohort without placebo control. Successive cohorts will be given doses up to 540 mg with placebo parallel control. Only no observation meets the criteria under stop rules, dose will escalate to the next higher level.

The study will be divided into 2 stages: 1st period (fast) and 2nd period(fed).

First period (fast): Subjects will be allocated 1:4 to receive placebo or SSS17, which will be administered by oral route. At each dose, tolerability, safety, PK and PD characteristics will be investigated.

Second period (fed): in order to investigate the effects of food on PK and PD of SSS17. Subjects in one cohort will be administered again after meal on Day15. The accurate dose will be adjusted according to the findings in 1st period (fast)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Hongzhou Lu, Ph.D
  • Phone Number: (021)37990333-5278
  • Email: jigouban@126.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201203
        • Shanghai Public Health Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body weight≥50 for male or ≥45 for female, and BMI between 19.0-26.0 kg/m2
  • Good general health as determined by the investigator based on medical history, physical examination, vital signs, 12-lead ECG, clinical laboratory tests and B-type ultrasound test.
  • Participants of reproductive potential must agree to utilize reliable methods of contraception from screening to 6 months after the last administration of the study intervention. No plan for sperm (or egg) donation or pregnancy.
  • Understand and sign the informed consent.
  • Ability to understand and follow study-related instruction

Exclusion Criteria:

  • A known allergy to any component of the SSS17 formulation, or allergy history of two kinds of drugs or food
  • Medical history or conditions of digestive system.
  • Female volunteers who are pregnant, menstrual, lactating or menopause with hormone therapy.
  • Eyes diseases, including diabetic retinopathy, age-related macular degeneration.
  • Vascular anomalies.
  • Drug, alcohol or nicotine addiction.
  • Blood donation or bleeding (more than 200 ml). Experience of treatment with EPO or blood transfusion.
  • Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ECG) deviating from normal and deemed by the investigator to be of clinical relevance
  • Abnormal results in test of TIBC, serum iron or ferritin
  • Acute diseases before administration.
  • Other situations that the researcher believes may affect validity judgment or are not suitable for participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dose Escalation SSS17
Escalating doses of SSS17; single dose administration; different dosage forms (redosing of the SSS17 in one cohort with food on Day15)
Drug: SSS17
SSS17 is a novel small molecule compound which stimulates erythropoiesis through inhibition of hypoxia-inducible factor- prolyl hydroxylases( HIF-PH). It is being developed for the treatment of anemia in patients with chronic kidney disease.
Placebo Comparator: Escalation matching Placebo
Escalating doses of matching placebo; single dose administration; different dosage forms (redosing of matching placebo in one cohort with food on Day15)
Drug: Placebo
matched placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AEs
Time Frame: up to Day14 or 29
assessment AEs by frequency, severity
up to Day14 or 29

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum plasma concentration (Cmax) of SSS17
Time Frame: [ up to 48 hours post-dose]
Plasma samples will be collected and Cmax will be assessed.
[ up to 48 hours post-dose]
Area under the concentration-time curve (AUC) of plasma concentration of SSS17
Time Frame: [ up to 48 hours post-dose]
Plasma samples will be collected and the AUC from zero to infinity will be assessed.
[ up to 48 hours post-dose]
Time-to-Cmax (Tmax) of SSS 17
Time Frame: [ up to 48 hours post-dose]
Plasma samples will be collected and the Tmax will be assessed from the concentration-time curve.
[ up to 48 hours post-dose]
Elimination terminal half-life (t1/2) of SSS17
Time Frame: [up to 48 hours post-dose]
Plasma samples will be collected and the t1/2 will be assessed.
[up to 48 hours post-dose]
Total amount of SSS17 excreted in urine over 24 hours (Ae0-24)
Time Frame: only for one cohort (up to 72 hours post-dose)
Urine sample will be collected at pre-specified intervals and Ae0-24 will be assessed.
only for one cohort (up to 72 hours post-dose)
Fraction of SSS17 excretion during each collection interval (Fe0-24)
Time Frame: only for one cohort (up to 72 hours post-dose)
Urine sample will be collected at pre-specified intervals and Fe0-24 will be assessed.
only for one cohort (up to 72 hours post-dose)
Total amount of SSS17 excreted in urine over 72 hours (Ae0-72)
Time Frame: only for one cohort (up to 72 hours post-dose)
Urine sample will be collected at pre-specified intervals and Ae0-72 will be assessed.
only for one cohort (up to 72 hours post-dose)
Fraction of SSS17 excretion during each collection interval (Fe0-72)
Time Frame: only for one cohort (up to 72 hours post-dose)
Urine sample will be collected at pre-specified intervals and Fe0-72 will be assessed.
only for one cohort (up to 72 hours post-dose)
Renal clearance (CLR) of SSS17
Time Frame: only for one cohort (up to 72 hours post-dose)
Urine sample will be collected at pre-specified intervals and CLR will be assessed.
only for one cohort (up to 72 hours post-dose)
EPO concentrations
Time Frame: up to 168 hours post-dose.
Change of EPO concentrations from baseline following SSS17
up to 168 hours post-dose.
VEGF concentrations
Time Frame: up to 168 hours post-dose.
Change of VEGF concentrations from baseline following SSS17
up to 168 hours post-dose.
Change of RTC from baseline
Time Frame: up to 168 hours post-dose.
Change of RTC from baseline following SSS17
up to 168 hours post-dose.
Change of RBC from baseline
Time Frame: up to 168 hours post-dose.
Change of RBC from baseline following SSS17
up to 168 hours post-dose.
Change of Hgb from baseline
Time Frame: up to 168 hours post-dose.
Change of Hgb from baseline following SSS17
up to 168 hours post-dose.
Change of hepcidin from baseline
Time Frame: up to 168 hours post-dose.
Change of serum hepcidin concentrations from baseline following SSS17
up to 168 hours post-dose.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shenyang Sunshine Pharmaceutical Co., LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SYSS-SSS17-UND-I-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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