Anemia in Chronic Kidney DiseasesPhase 1NCT04317833
A Study of SSS17 in Healthy Subjects
A Phase 1 study testing SSS17 in people with Anemia in Chronic Kidney Diseases, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anemia in Chronic Kidney Diseases
- What is being tested?
- SSS17
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to 31 Dec 2021
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201203
Hongzhou Lu
Hongzhou Lu
About this study
Official title: 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.
Read the 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)
- Conditions
- Anemia in Chronic Kidney Diseases
- Being tested
- SSS17, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSS17Drug
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.
PlaceboDrug
matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation SSS17 | Experimental | Escalating doses of SSS17; single dose administration; different dosage forms (redosing of the SSS17 in one cohort with food on Day15) Receives: Drug: SSS17 |
| Escalation matching Placebo | Placebo comparator | Escalating doses of matching placebo; single dose administration; different dosage forms (redosing of matching placebo in one cohort with food on Day15) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs
assessment AEs by frequency, severity
Measured: up to Day14 or 29
Secondary outcomes (15)
Maximum plasma concentration (Cmax) of SSS17
Plasma samples will be collected and Cmax will be assessed.
Measured: [ up to 48 hours post-dose]
Area under the concentration-time curve (AUC) of plasma concentration of SSS17
Plasma samples will be collected and the AUC from zero to infinity will be assessed.
Measured: [ up to 48 hours post-dose]
Time-to-Cmax (Tmax) of SSS 17
Plasma samples will be collected and the Tmax will be assessed from the concentration-time curve.
Measured: [ up to 48 hours post-dose]
Elimination terminal half-life (t1/2) of SSS17
Plasma samples will be collected and the t1/2 will be assessed.
Measured: [up to 48 hours post-dose]
Total amount of SSS17 excreted in urine over 24 hours (Ae0-24)
Urine sample will be collected at pre-specified intervals and Ae0-24 will be assessed.
Measured: only for one cohort (up to 72 hours post-dose)
Fraction of SSS17 excretion during each collection interval (Fe0-24)
Urine sample will be collected at pre-specified intervals and Fe0-24 will be assessed.
Measured: only for one cohort (up to 72 hours post-dose)
Total amount of SSS17 excreted in urine over 72 hours (Ae0-72)
Urine sample will be collected at pre-specified intervals and Ae0-72 will be assessed.
Measured: only for one cohort (up to 72 hours post-dose)
Fraction of SSS17 excretion during each collection interval (Fe0-72)
Urine sample will be collected at pre-specified intervals and Fe0-72 will be assessed.
Measured: only for one cohort (up to 72 hours post-dose)
Renal clearance (CLR) of SSS17
Urine sample will be collected at pre-specified intervals and CLR will be assessed.
Measured: only for one cohort (up to 72 hours post-dose)
EPO concentrations
Change of EPO concentrations from baseline following SSS17
Measured: up to 168 hours post-dose.
VEGF concentrations
Change of VEGF concentrations from baseline following SSS17
Measured: up to 168 hours post-dose.
Change of RTC from baseline
Change of RTC from baseline following SSS17
Measured: up to 168 hours post-dose.
Change of RBC from baseline
Change of RBC from baseline following SSS17
Measured: up to 168 hours post-dose.
Change of Hgb from baseline
Change of Hgb from baseline following SSS17
Measured: up to 168 hours post-dose.
Change of hepcidin from baseline
Change of serum hepcidin concentrations from baseline following SSS17
Measured: up to 168 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start1 May 2020 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia in Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Shenyang Sunshine Pharmaceutical Co., LTD.The sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317833
- Sponsor's protocol ID
- SYSS-SSS17-UND-I-01
- Status last verified
- Mar 2020
- First submitted
- 19 Mar 2020
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose Escalation Study to Investigate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of SSS17 in Chinese Healthy Subject
- ClinicalTrials.gov ID
- NCT04317833
- Acronym / sponsor ID
- SYSS-SSS17-UND-I-01
- Conditions
- Anemia in Chronic Kidney Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 23 Mar 2020 (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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation SSS17 | Experimental | Drug: SSS17Escalating doses of SSS17; single dose administration; different dosage forms (redosing of the SSS17 in one cohort with food on Day15) |
| Escalation matching Placebo | Placebo comparator | Drug: PlaceboEscalating doses of matching placebo; single dose administration; different dosage forms (redosing of matching placebo in one cohort with food on Day15) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| SSS17SSS17 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. | Drug | Dose Escalation SSS17 |
| Placebomatched placebo | Drug | Escalation matching Placebo |
Primary outcome
AEs
Time frame: up to Day14 or 29
assessment AEs by frequency, severity
15 secondary outcomes
Maximum plasma concentration (Cmax) of SSS17
Time frame: [ 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]
Time-to-Cmax (Tmax) of SSS 17
Time frame: [ up to 48 hours post-dose]
Elimination terminal half-life (t1/2) of SSS17
Time frame: [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)
Fraction of SSS17 excretion during each collection interval (Fe0-24)
Time frame: 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)
Fraction of SSS17 excretion during each collection interval (Fe0-72)
Time frame: 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)
EPO concentrations
Time frame: up to 168 hours post-dose.
VEGF concentrations
Time frame: up to 168 hours post-dose.
Change of RTC from baseline
Time frame: up to 168 hours post-dose.
Change of RBC from baseline
Time frame: up to 168 hours post-dose.
Change of Hgb from baseline
Time frame: up to 168 hours post-dose.
Change of hepcidin from baseline
Time frame: up to 168 hours post-dose.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SSS17 in people with Anemia in Chronic Kidney Diseases, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.
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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 23 Mar 2020. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongzhou Lu, Ph.D ((021)37990333-5278, jigouban@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AEs (time frame: up to Day14 or 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2020.