Idiopathic Pulmonary FibrosisPhase 1NCT04512170
Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC585 in Healthy Male and Female Subjects
A Phase 1 study testing HEC585 in people with Idiopathic Pulmonary Fibrosis, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
The Safety, Tolerability Pharmacokinetic and Food Effect Study of HEC585 in Healthy Male and Female 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?
- HEC585
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 13 Jul 2020to 23 Aug 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who are willing and are able to provide a written informed consent to participate in the study.
- Without Plann for pregnancy or pregnant within 3 months after enrollment throughout the trial.
- Subjects aged between 18 and 45 (both inclusive) years old.
- Healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥19 and ≤28 kg/m2 at screening.
- Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG).
Who cannot join
- Subjects with a positive serology for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies and/or TP antibodies at screening.
- Subjects suffering from gastrointestinal diseases that can interfere with absorption or metabolism of drugs within 6 months before screening; and/or with history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system (such as thymus disease), reproductive system (such as prostate, testis, epididymis, ovarian disease); and/or thyroid disease or previous thyroid surgery, malignant tumor, metabolic disorder or others medical conditions (such as history of mental illness, etc.) that are not suitable for clinical trial participation.
- Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s)， anaphylaxis physique.
- Use of any prescription or non-prescription medications within 14 days prior to initial dosing，Use of any medications known to inhibit or induce cytochrome P enzyme drug metabolism within 28 days prior to initial dosing.
- Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
- Positive results from urine drug screen test.
Show all 13Show fewer
- History of alcoholism or drink regularly within 3 months prior to the study(defined as Alcohol consumption of > 21 units/week), or positive results from alcohol breath test.
- Regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug, or inability to refrain from smoking during the course of the study.
- Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.
- Subjects who plan to receive or have had organ transplants.
- Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential.
- Subjects who participated in another clinical trial within 3 months prior to initial dosing.
- Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of Ascending Single and Multiple Doses to Evaluate the Safety, Tolerability, Pharmacokinetics, and Randomized, Open-label，Crossover, Food Effect Study of HEC585 in Healthy Chinese Subjects
The Safety, Tolerability Pharmacokinetic and Food Effect Study of HEC585 in Healthy Male and Female Subjects
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- HEC585, placebo
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEC585Drug
single or Mulltiple doses up to 10 days
placeboDrug
single or Mulltiple doses up to 10 days
| Study group | Role | What they receive |
|---|---|---|
| A single dose HEC585（pilot trial arm） | Experimental | Healthy subjects receive a single dose of HEC585 Receives: Drug: HEC585 |
| Single and Mulltiple doses HEC585（ Part 1, Cohort 1） | Experimental | Healthy subjects receive Single and multiple doses of HEC585 or matching placebo Receives: Drug: HEC585; Drug: placebo |
| Single and Mulltiple doses HEC585（ Part 1, Cohort 2） | Experimental | Healthy subjects receive Single and multiple doses of HEC585 or matching placebo Receives: Drug: HEC585; Drug: placebo |
| Single and Mulltiple doses HEC585（ Part 1, Cohort 3） | Experimental | Healthy subjects receive Single and multiple doses of HEC585 or matching placebo Receives: Drug: HEC585; Drug: placebo |
| Single dose of HEC585 （Part 2，Fed/Fasting） | Experimental | Following an overnight fast of at least 10 hours, a single dose of HEC585 will be administered on 2 separate occasions (fasting and after meal) in a randomized crossover fashion with different food restrictions. Receives: Drug: HEC585; Drug: placebo |
| two-period study at 400 mg dose group (part 3，Fed) | Experimental | Healthy subjects receive Single/multiple doses of HEC585 or matching placebo in two cycles. Receives: Drug: HEC585; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of HEC585 by Assessment of the Number of Adverse Events (AEs) Following Administration of Oral Solution in Single Ascending Dose and Multiple Ascending Doses
To investigate the safety and tolerability of HEC585 by assessment of AEs (non-serious and serious) following administration of oral solution in SAD and MAD
Measured: up to 18 days
Secondary outcomes (9)
PK parameters - AUC0-∞
area under the concentration versus time curve (AUC) from time zero to infinity
Measured: up to 96 hours
PK parameters - Cmax
Geometric Mean of Maximum Observed Plasma Concentration of HEC585
Measured: up to 96 hours
PK parameters -tmax
maximum observed plasma concentration
Measured: up to 96 hours
PK parameters -t½
apparent terminal elimination half-life
Measured: up to 96 hours
PK parameters -Vz/F
apparent volume of distribution
Measured: up to 96 hours
PK parameters - MRT
the Mean Residence Time
Measured: up to 96 hours
PK parameters -CL/F
the Apparent Clearance
Measured: up to 96 hours
PK parameters -R
the Accumulation Ratio
Measured: up to 96 hours
Food Effect
Effect of Food on PK parameters of HEC585
Measured: up to 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start13 Jul 2020
- Primary completion23 Aug 2021
- Study completion23 Aug 2021
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512170
- Sponsor's protocol ID
- HEC585-P-02 / CRC-C1938
- Status last verified
- Mar 2022
- First submitted
- 7 Aug 2020
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of Ascending Single and Multiple Doses to Evaluate the Safety, Tolerability, Pharmacokinetics, and Randomized, Open-label，Crossover, Food Effect Study of HEC585 in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT04512170
- Acronym / sponsor ID
- HEC585-P-02 / CRC-C1938
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 23 Aug 2021 (actual)
- Study completion
- 23 Aug 2021 (actual)
- First posted
- 13 Aug 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.
The Safety, Tolerability Pharmacokinetic and Food Effect Study of HEC585 in Healthy Male and Female Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A single dose HEC585（pilot trial arm） | Experimental | Drug: HEC585Healthy subjects receive a single dose of HEC585 |
| Single and Mulltiple doses HEC585（ Part 1, Cohort 1） | Experimental | Drug: HEC585, Drug: placeboHealthy subjects receive Single and multiple doses of HEC585 or matching placebo |
| Single and Mulltiple doses HEC585（ Part 1, Cohort 2） | Experimental | Drug: HEC585, Drug: placeboHealthy subjects receive Single and multiple doses of HEC585 or matching placebo |
| Single and Mulltiple doses HEC585（ Part 1, Cohort 3） | Experimental | Drug: HEC585, Drug: placeboHealthy subjects receive Single and multiple doses of HEC585 or matching placebo |
| Single dose of HEC585 （Part 2，Fed/Fasting） | Experimental | Drug: HEC585, Drug: placeboFollowing an overnight fast of at least 10 hours, a single dose of HEC585 will be administered on 2 separate occasions (fasting and after meal) in a randomized crossover fashion with different food restrictions. |
| two-period study at 400 mg dose group (part 3，Fed) | Experimental | Drug: HEC585, Drug: placeboHealthy subjects receive Single/multiple doses of HEC585 or matching placebo in two cycles. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects who are willing and are able to provide a written informed consent to participate in the study.
- Without Plann for pregnancy or pregnant within 3 months after enrollment throughout the trial.
- Subjects aged between 18 and 45 (both inclusive) years old.
- Healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥19 and ≤28 kg/m2 at screening.
- Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG).
Key exclusion criteria (13 listed)
- Subjects with a positive serology for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies and/or TP antibodies at screening.
- Subjects suffering from gastrointestinal diseases that can interfere with absorption or metabolism of drugs within 6 months before screening; and/or with history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system (such as thymus disease), reproductive system (such as prostate, testis, epididymis, ovarian disease); and/or thyroid disease or previous thyroid surgery, malignant tumor, metabolic disorder or others medical conditions (such as history of mental illness, etc.) that are not suitable for clinical trial participation.
- Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s)， anaphylaxis physique.
- Use of any prescription or non-prescription medications within 14 days prior to initial dosing，Use of any medications known to inhibit or induce cytochrome P enzyme drug metabolism within 28 days prior to initial dosing.
- Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
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 |
|---|---|---|
| HEC585single or Mulltiple doses up to 10 days | Drug | A single dose HEC585（pilot trial arm）, Single and Mulltiple doses HEC585（ Part 1, Cohort 1）, Single and Mulltiple doses HEC585（ Part 1, Cohort 2）, Single and Mulltiple doses HEC585（ Part 1, Cohort 3）, Single dose of HEC585 （Part 2，Fed/Fasting）, two-period study at 400 mg dose group (part 3，Fed) |
| placebosingle or Mulltiple doses up to 10 days | Drug | Single and Mulltiple doses HEC585（ Part 1, Cohort 1）, Single and Mulltiple doses HEC585（ Part 1, Cohort 2）, Single and Mulltiple doses HEC585（ Part 1, Cohort 3）, Single dose of HEC585 （Part 2，Fed/Fasting）, two-period study at 400 mg dose group (part 3，Fed) |
Primary outcome
Safety and Tolerability of HEC585 by Assessment of the Number of Adverse Events (AEs) Following Administration of Oral Solution in Single Ascending Dose and Multiple Ascending Doses
Time frame: up to 18 days
To investigate the safety and tolerability of HEC585 by assessment of AEs (non-serious and serious) following administration of oral solution in SAD and MAD
9 secondary outcomes
PK parameters - AUC0-∞
Time frame: up to 96 hours
PK parameters - Cmax
Time frame: up to 96 hours
PK parameters -tmax
Time frame: up to 96 hours
PK parameters -t½
Time frame: up to 96 hours
PK parameters -Vz/F
Time frame: up to 96 hours
PK parameters - MRT
Time frame: up to 96 hours
PK parameters -CL/F
Time frame: up to 96 hours
PK parameters -R
Time frame: up to 96 hours
Food Effect
Time frame: up to 96 hours
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 15 Mar 2022.
- 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 HEC585 in people with Idiopathic Pulmonary Fibrosis, run by Sunshine Lake 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 13 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 15 Mar 2022. 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?
Safety and Tolerability of HEC585 by Assessment of the Number of Adverse Events (AEs) Following Administration of Oral Solution in Single Ascending Dose and Multiple Ascending Doses (time frame: up to 18 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 15 Mar 2022.