Idiopathic Pulmonary FibrosisPhase 1NCT06135363
Safety, Tolerability and Pharmacokinetic Study of SC1011 in Healthy Subjects
A Phase 1 study testing SC1011 in people with Idiopathic Pulmonary Fibrosis, run by Guangzhou JOYO Pharma Co., Ltd at 1 site in China.
Trial summary
The goal of this clinical trial is to learn about the safety, tolerability and pharmacokinetic profiles of SC1011 in healthy conditions. The main questions it aims to answer are: Safety and tolerability profiles in healthy subjects and pharmacokinetic profiles in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- SC1011
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 11 Aug 2022to 14 Jan 2023
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females, of any race, between 18 and 45 years of age, inclusive, at Screening.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at Screening and/or Check-in as assessed by the Investigator.
- Females will be nonpregnant and nonlactating. Females of childbearing potential and male subjects will agree to use contraception.
- Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.
Who cannot join
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance.
- Alcohol consumption of > 21 units per week for males and > 14 units for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL wine), or a positive alcohol breath test at Check-in.
- Any screening laboratory or ECG results are not within the normal reference range and are considered clinically significant.
- Participants who participated in other clinical trials within 3 months prior to administration.
- Blood donation or blood loss exceeding 400 mL within 2 months prior to administration.
- Participants who smoked, drank alcohol, tea, food or drink containing xanthine or caffeine, or had strenuous exercise, or had other factors affecting drug absorption, distribution, metabolism and excretion 2 days before drug administration.
- Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Xuhui District Central Hospital
Shanghai, Shanghai Municipality, 200020
About this study
Official title: A Single-center, Open Label Study to Evaluate the Safety，Tolerability and Pharmacokinetics of Multiple Administration of Sufenidone (SC1011) Tablets in Healthy Adult Volunteers
The goal of this clinical trial is to learn about the safety, tolerability and pharmacokinetic profiles of SC1011 in healthy conditions. The main questions it aims to answer are: Safety and tolerability profiles in healthy subjects and pharmacokinetic profiles in healthy subjects. Participants will complete the study including screening period, dosing period, and observation period. Investigators will compare the inhibitory activity of SC1011 tablets with pirfenidone capsules against the same biomarkers(e.g. blood TNFα) to see if they are different between the two drugs.
Read the detailed description
This is a single-center, open label study to evaluate the safety，tolerability and pharmacokinetics of multiple administration of Sufenidone (SC1011) tablets conducted in 2 groups.
Eight subjects were enrolled in the sulforaphane 300 mg group and each subject was administered once within half an hour after breakfast on day 1, twice daily on days 2-6 and once within half an hour after breakfast on day 7 .
Eight subjects were enrolled in the sulforaphane 400 mg group and each subject was administered for 7 consecutive days, with dosing consisting of one dose within half an hour after breakfast on day 1, twice daily on days 2-6, and once within half an hour after breakfast on day 7.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- SC1011, Placebo tablet
- Keywords
- Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis, Lung Diseases, Respiratory Tract Diseases
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Lung Diseases, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SC1011Drug
Also called experimental drug group
SC1011 tablet
Placebo tabletDrug
Also called Control Group
SC1011-matching placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Multiple doses SC1011 300mg（A1） | Experimental | Drug: SC1011 tablet, SC1011-matching placebo tablet; Treatment: Food intake prior to dosing Receives: Drug: SC1011; Drug: Placebo tablet |
| Multiple doses SC1011 400mg（A2） | Experimental | Drug: SC1011 tablet; Treatment: Food intake prior to dosing Receives: Drug: SC1011; Drug: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events and serious adverse events related drug.
Adverse events are coded according to the ICH Medical Dictionary of Regulatory Activities (MedDRA 24.0 or above). ADR: Adverse events that are "definitely related, probably related, or undetermined" in relation to the investigational drug.
Measured: From baseline to 7 days
Secondary outcomes (1)
Geometric Mean of Maximum Observed Plasma Concentration of SC1011
Area under the plasma concentration-time curve (AUC) from time zero to infinity of SC1011
Measured: From baseline to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start11 Aug 2022
- Primary completion14 Jan 2023
- Study completion14 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou JOYO Pharma Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135363
- Sponsor's protocol ID
- JYP1011M102
- Status last verified
- Oct 2023
- First submitted
- 4 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open Label Study to Evaluate the Safety，Tolerability and Pharmacokinetics of Multiple Administration of Sufenidone (SC1011) Tablets in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT06135363
- Acronym / sponsor ID
- JYP1011M102
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis, Lung Diseases, Respiratory Tract Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Guangzhou JOYO Pharma Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 14 Jan 2023 (actual)
- Study completion
- 14 Jan 2023 (actual)
- First posted
- 18 Nov 2023 (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.
The goal of this clinical trial is to learn about the safety, tolerability and pharmacokinetic profiles of SC1011 in healthy conditions. The main questions it aims to answer are: Safety and tolerability profiles in healthy subjects and pharmacokinetic profiles in healthy subjects. Participants will complete the study including screening period, dosing period, and observation period. Investigators will compare the inhibitory activity of SC1011 tablets with pirfenidone capsules against the same biomarkers(e.g. blood TNFα) to see if they are different between the two drugs.
Detailed description
This is a single-center, open label study to evaluate the safety，tolerability and pharmacokinetics of multiple administration of Sufenidone (SC1011) tablets conducted in 2 groups.
Eight subjects were enrolled in the sulforaphane 300 mg group and each subject was administered once within half an hour after breakfast on day 1, twice daily on days 2-6 and once within half an hour after breakfast on day 7 .
Eight subjects were enrolled in the sulforaphane 400 mg group and each subject was administered for 7 consecutive days, with dosing consisting of one dose within half an hour after breakfast on day 1, twice daily on days 2-6, and once within half an hour after breakfast on day 7.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple doses SC1011 300mg（A1） | Experimental | Drug: SC1011, Drug: Placebo tabletDrug: SC1011 tablet, SC1011-matching placebo tablet; Treatment: Food intake prior to dosing |
| Multiple doses SC1011 400mg（A2） | Experimental | Drug: SC1011, Drug: Placebo tabletDrug: SC1011 tablet; Treatment: Food intake prior to dosing |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males or females, of any race, between 18 and 45 years of age, inclusive, at Screening.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at Screening and/or Check-in as assessed by the Investigator.
- Females will be nonpregnant and nonlactating. Females of childbearing potential and male subjects will agree to use contraception.
- Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.
Key exclusion criteria (8 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance.
- Alcohol consumption of > 21 units per week for males and > 14 units for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL wine), or a positive alcohol breath test at Check-in.
- Any screening laboratory or ECG results are not within the normal reference range and are considered clinically significant.
- Participants who participated in other clinical trials within 3 months prior to administration.
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 |
|---|---|---|
| SC1011Also: experimental drug groupSC1011 tablet | Drug | Multiple doses SC1011 300mg（A1）, Multiple doses SC1011 400mg（A2） |
| Placebo tabletAlso: Control GroupSC1011-matching placebo tablet | Drug | Multiple doses SC1011 300mg（A1）, Multiple doses SC1011 400mg（A2） |
Primary outcome
Incidence and severity of adverse events and serious adverse events related drug.
Time frame: From baseline to 7 days
Adverse events are coded according to the ICH Medical Dictionary of Regulatory Activities (MedDRA 24.0 or above). ADR: Adverse events that are "definitely related, probably related, or undetermined" in relation to the investigational drug.
1 secondary outcome
Geometric Mean of Maximum Observed Plasma Concentration of SC1011
Time frame: From baseline to 7 days
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 18 Nov 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 SC1011 in people with Idiopathic Pulmonary Fibrosis, run by Guangzhou JOYO Pharma 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 8 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 18 Nov 2023. 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. 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?
Incidence and severity of adverse events and serious adverse events related drug. (time frame: From baseline to 7 days). 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 18 Nov 2023.