Idiopathic Pulmonary FibrosisPhase 1NCT06482190
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of RSN0402 in Healthy Volunteers
A Phase 1 study testing RSN0402 Part 1 and RSN0402 Part 2 in people with Idiopathic Pulmonary Fibrosis and Lung; Disease, Interstitial, With Fibrosis, run by Shenzhen Resproly Biopharmaceutical Co., Ltd at 3 sites in Australia.
Trial summary
This is a phase 1, randomized, First in Human (FIH), double-blinded, placebo-controlled study to assess the safety, tolerability, and PK of RSN0402 in healthy volunteers. A total of about 72 participants are expected to be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Lung; Disease, Interstitial, With Fibrosis
- What is being tested?
- RSN0402 Part 1 and RSN0402 Part 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 3 sitesAustralia
- Study dates
- 11 Jul 2024to 10 Feb 2025
- 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
- Participant is overtly healthy or has no clinically significant condition as determined by PI/Sub-Investigator including medical history, vital signs, ECG, laboratory tests, and physical examination at Screening and admission (Day -2 and Day -1).
- Participant has normal lung function assessment with FEV1 of at least 80% of the predicted value and FEV1/FVC ratio of > 0.7 measured at Screening.
- Availability to participate voluntarily for the entire study duration and willing to adhere to all protocol requirements.
- Participant must be 18 to 60 years of age inclusive, at the time of signing the informed consent.
- Male participant with body weight of ≥ 50.0 kg, female participant with body weight ≥ 45.0 kg; males or females with body mass index (BMI) of ≥ 18 to < 30.0 kg/m² at screening.
- Female participants of childbearing potential must have a negative serum pregnancy test result at Screening and a negative pregnancy test result at Baseline and agree to use acceptable methods of contraception as per protocol.
- Male participants agree to use acceptable methods of contraception if the male participant's partner could become pregnant from the time of signing the informed consent until 3 months after EOS/ET.
Who cannot join
- Vulnerable participants (ie, people under any administrative or legal supervision).
- Clinical laboratory evidence or clinical diagnosis of human immunodeficiency virus (HIV) infection, hepatitis C virus (HCV) infection, or chronic hepatitis B virus (HBV) infection (as shown by hepatitis B surface antigen [HbsAg] positivity).
- Evidence of a clinically significant cardiovascular, renal, hepatic, hematological, gastrointestinal (GI), pulmonary, metabolic-endocrine, neurological, or psychiatric disease or psychiatric disease within the previous 2 years; or evidence of active airway infection.
- Known hypersensitivity to the active substance(s) of the drug or its excipient (lactose monohydrate, which contains small amounts of milk protein) and/or intolerance with lactose.
- History of vasovagal syncope in past 5 years.
- History of anaphylactic/anaphylactoid reactions.
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- History of seizures including febrile seizures.
- History of bleeding disorders or currently being treated with anticoagulants or regular using aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).
- History of thrombotic event (including stroke and transient ischemic attack) within 6 months prior to Screening.
- History of pulmonary arterial hypertension.
- Cardiovascular diseases, any of the following: Severe hypertension (uncontrolled under treatment ≥ 160/100 mmHg at multiple occasions) within 3 months prior to Screening; history of myocardial infarction; history of unstable cardiac angina
- Surgery of the GI tract (except appendectomy or simple hernia repair).
- Any condition requiring regular concomitant treatment (including vitamins, recreational drugs, and dietary or herbal products) or likely to need any concomitant treatment during the study. As an exception, paracetamol and ibuprofen for occasional pain will be allowed.
- Intake of any medication that could affect the outcome of the study. As an exception, contraceptives and hormone replacement therapy are allowed. The use of medicines that are potential CYP3A4 inducers or inhibitors will be restricted for at least 2 weeks prior to the first dose of the IP and during the study.
- Use of any prescription drugs or the medication leading to prolong the QT/QTc interval within 14 days or 7 half-lives (whichever is longer) prior to dosing; over the-counter (OTC) medication, supplements, or vitamins within 7 days or 7 half lives (whichever is longer) prior to the first dose of the IP.
- Administration of another investigational drug within the past 30 days prior to the first dose of IP.
- Any clinically significant abnormal laboratory value or physical finding (including vital signs) that may interfere with the interpretation of study results or constitute a health risk for the participant if he/she takes part in the study, as judged by the PI/Sub-Investigator. More specifically, respiratory rate < 12 or > 22 rpm, heart rate (HR) < 45 or > 100 bpm, or systolic blood pressure (BP) ≥ 140 or < 90 or diastolic BP ≥ 90 or < 60 mmHg, or oxygen saturation < 95% after a 5-minute rest. Repeat tests are permitted at Investigator's discretion.
- Abnormal ECG findings (eg, QTcF > 450 msec [male] or > 470 msec [female]) at Screening and admission (Day -2 and Day -1). Repeat tests are permitted at Investigator's discretion
- Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) > 1.5 x upper limit of normal (ULN) or total Bilirubin > 1.5 x ULN.
- Pregnant or lactating females.
- Women of childbearing potential (WOCBP) who are sexually active with the opposite sex not using acceptable effective methods of contraception (mechanical and/or hormonal contraception, intrauterine device, intrauterine hormonal releasing system or surgical sterilization, vasectomized partner etc.).
- Participants with a positive result of drug abuse test or with a history of drug abuse at Screening.
- Participants with a history of alcohol abuse within 1 month prior to Screening (average consuming 14 units or more of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 125 mL of wine) or with a positive result of alcohol breath test at Screening.
- Use of tobacco- or nicotine-containing products (eg, nicotine patches or vaporizing devices) within 3 months prior to Screening or a positive result of urine cotinine test at Screening.
- Participants who consume food or beverage containing grapefruit/pomelo or alcohol/caffeine (eg, coffee, chocolate, cola, tea, etc.) within 48 hours prior to confinement and during the confinement.
- Blood donation or loss of significant amount (≥ 200 mL) of blood within 30 days prior to the first dose of IP administration.
- Unsuitable veins for repeated venipuncture or for cannulation.
- Inability to learn the correct inhalation technique.
- Predictable poor compliance.
- Judged to be not eligible by the Investigator/Sponsor for any other reason
Trial locations and contacts
3 sites in 1 country.
Australia3 sites, 3 recruiting
- Recruiting
Nucleus Network Pty Ltd
Geelong, Victoria, 3220
Christina Catherine Chang, Dr
- Recruiting
Nucleus Network
Melbourne, Victoria, 3004
Christina Catherine Chang, Dr
- Recruiting
Nucleus Network Pty Ltd
Melbourne, 3004
Christina Catherine Chang, Dr, c.chang@nucleusnetwork.com.au
About this study
Official title: A Phase 1, Randomized, Double Blinded, Placebo Controlled, First-in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses and Multiple Ascending Doses of RSN0402 in Healthy Volunteers
This is a phase 1, randomized, First in Human (FIH), double-blinded, placebo-controlled study to assess the safety, tolerability, and PK of RSN0402 in healthy volunteers. A total of about 72 participants are expected to be enrolled.
Read the detailed description
This study consists of 3 parts. SAD Part: The participants in the SAD cohorts of the study (Cohort 1 to Cohort 5) will receive a single dose of RSN0402 at 2, 4, 8, 12, or 16 mg dose or placebo via inhalation using a dry powder inhalant. Participants from Cohort 2 will receive a single dose of 150 mg nintedanib soft capsule after 7-day washout period. After completion of Cohort 3, SRC will decide whether to enrol Cohort 4 sequentially or to skip Cohort 4 and enrol Cohort 5 directly based on the safety and PK data collected from the Cohort 1 to Cohort 3. If there are no safety concerns, Cohort 5 will be enrolled after Cohort 3.
MAD Part: The MAD Part consists of 4 cohorts with 8 participants in each cohort. Participants will be randomly assigned to receive RSN0402 (4, 8, 12, or 16 mg) or placebo for 7 days at a ratio of 3:1. In MAD study, the IP will be administered once daily from Day 1 to Day 7. The doses in MAD Part of the study could be adjusted at the discretion of the SRC based on the review of data from the SAD cohorts. The dose regimen in MAD Part may also be adjusted to twice daily or another regimen if there is any concern after SRC review of the available data from SAD cohorts. The adjusted dose and dose regimen cannot exceed the maximum safety daily dose confirmed in the SAD Part.
- Being tested
- RSN0402 Part 1, RSN0402 Part 2, Placebo
- Keywords
- Respiratory system
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSN0402 Part 1Drug
Participants will receive single ascending doses of 2mg, 4mg, 8mg, 12 mg, and 16mg of RSN0402 or placebo on Day 1 for Cohort 1 to 5. Cohort 2(4mg) will also a single dose of 150 mg nintedanib soft capsule will be administered orally after at least 7-days washout period.
RSN0402 Part 2Drug
Participants will receive multiple ascending doses of 4mg ,8mg,12mg ,16mg of RSN0402 or placebo administered once daily from Day 1 to Day 7 for Cohort 6 to 9.
PlaceboDrug
Participants will receive matching placebo across Part 1 and Part 2 of the study.
| Study group | Role | What they receive |
|---|---|---|
| RSN0402 Part 1 | Experimental | Part 1 is SAD with 5 cohorts (1 to 5) where each participant will receive single dose of RSN0402 powder for inhalation or placebo following a 10hour fast. Cohort 2 will also receive single dose of nintedanib oral soft capsule. Receives: Drug: RSN0402 Part 1 |
| RSN0402 Part 2 | Experimental | Part 2 is MAD with 4 cohorts (6 to 9) where each participant will receive multiple doses powder for inhalation or placebo following a 10 hr fast. Receives: Drug: RSN0402 Part 2 |
| Placebo | Placebo comparator | Matching doses of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Treatment emergent Adverse events (TEAEs)
TEASs will be collected to assess participant's safety after RSN0402 administration in both Single ascending dose (SAD) and multiple ascending dose (MAD).
Measured: SAD - From Screening to Day 14 (end of study); MAD - From Screening to Day 13 (end of study)
Number of participants with changes in physical examination
Full physical examination will comprise a routine medical examination including examination of head, eyes, ears, nose, throat and neck, abdomen, the respiratory system, central and peripheral nervous system, cardiovascular system, gastrointestinal system including mouth, musculoskeletal system, and skin. Brief physical examination will include at a minimum, assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen).
Measured: SAD- From Screening to Day 14 (end of study) post dose; MAD - At screening, Day -2, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 13 (end of study) post dose.
Number of participants with changes in serum blood parameters
Serum blood parameters include hematology, biochemistry, coagulation
Measured: SAD- At Screening, Day -2, Day 3, Day 7, Day 10 and Day 14 (end of study) post dose; MAD- At Screening, Day -2, Day 3, Day 6, Day 9 and Day 13 (end of study) post dose.
Number of participants with changes in Urine parameters
Urine cotinine test and urine pregnancy test will be assessed
Measured: SAD: Urine pregnancy test will be conducted on Day -2 and Day 7 and Urine cotinine test in screening, Day -2 and Day 7 post first dose. MAD: Urine pregnancy test will be conducted on Day -2, Urine cotinine test in screening and Day -2.
Number of participants with changes in vital signs
Heart rate, systolic/diastolic blood pressure, respiratory rate, oxygen saturation, and temperature
Measured: SAD- At Screening, Day-2, Day 1, Day 2, Day 3, Day 7, Day 8, Day 9, Day 10 and Day 14 (end of study) post dose; MAD - At screening, Day - 2, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 13 (end of study) post dose.
Number of participants with change in Absolute Forced Expiratory Volume in 1 second (FEV1) >10%
Spirometry will be conducted in accordance with ATS and ERS guidelines
Measured: SAD- At Screening, Day -2, Day 1, Day 2, Day 3, Day 7, Day 8, Day 9, Day 10 and Day 14 (end of study) post dose; MAD - At screening, Day- 2, Day 1, Day 3, Day 6, Day 9 and Day 13 (end of study) post dose.
Secondary outcomes (13)
Changes in AUC 0-inf (Area under curve from time 0 to infinity) of RSN0402 with 5 different doses of SAD.PK samples are collected at total of 17 time points from pre-dose and up to 48 hours after dosing on Day 3.
Measured: SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10 post first dose; MAD- Day 1 to Day 9 post dose
PK parameter: Changes in AUC 0-t (Area under curve from time 0 to last measurable concentration) of RSN0402.
PK samples are collected at total of 17 time points from pre-dose and up to 48 hours after dosing for SAD cohorts:17 timepoints from pre-dose to 48 hours post dose.
Measured: SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
PK parameter: Changes in Cmax (Maximum observed plasma concentration) of RSN0402
PK samples are collected at total of 17 time points from pre-dose and up to 48 hours after dosing for SAD cohorts:17 timepoints from pre-dose to 48 hours post dose.
Measured: SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
PK parameter: Changes in Tmax (Time to Maximum) of RSN0402
PK samples are collected at total of 17 time points from pre-dose and up to 48 hours after dosing for SAD cohorts:17 timepoints from pre-dose to 48 hours post dose.
Measured: SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
PK parameter: Changes in t1/2 (Apparent terminal elimination half-life) of RSN0402
PK samples are collected at total of 17 time points from pre-dose and up to 48 hours after dosing for SAD cohorts:17 timepoints from pre-dose to 48 hours post dose.
Measured: SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
PK parameter: Changes in CL/F (Apparent systemic clearance) of RSN0402
PK samples are collected at total of 17 time points from pre-dose and up to 48 hours after dosing for SAD cohorts:17 timepoints from pre-dose to 48 hours post dose.
Measured: SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
PK parameter: Changes in Vz/F (Apparent volume of distribution) of RSN0402
PK samples are collected at total of 17 time points from pre-dose and up to 48 hours after dosing for SAD cohorts:17 timepoints from pre-dose to 48 hours post dose.
Measured: SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
PK parameter: Changes in AUCτ(Area under curve) of RSN0402
Measured: SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
PK parameter: Changes in Cmax,ss (Cmax at steady state) of RSN0402
Measured: SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
PK parameter: Changes in Ctrough (trough concentration) of RSN0402
Measured: SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
PK parameter: Changes in Tmax,ss (Tmax at steady state) of RSN0402
Measured: SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
PK parameter: Changes in Vss/F (Apparent steady state volume of distribution) of RSN0402
Measured: SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
PK parameter: Change from Baseline in QT interval corrected by Fridericia's formula (QTcF)
Measured: SAD - At Screening, Day-2, Day 1, Day 2, Day 3 and Day 7 (end of study) post dose; MAD - At screening, Day 2, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 13 (end of study) post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start11 Jul 2024 (estimated)
- Primary completion27 Dec 2024 (estimated)
- Study completion10 Feb 2025 (estimated)
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 (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Resproly Biopharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Resproly Australia Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482190
- Sponsor's protocol ID
- RES-RSN0402-P1
- Status last verified
- Jun 2024
- First submitted
- 25 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double Blinded, Placebo Controlled, First-in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses and Multiple Ascending Doses of RSN0402 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06482190
- Acronym / sponsor ID
- RES-RSN0402-P1
- Keywords
- Respiratory system
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Shenzhen Resproly Biopharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Resproly Australia Pty Ltd
- Study start
- 11 Jul 2024 (estimated)
- Primary completion
- 27 Dec 2024 (estimated)
- Study completion
- 10 Feb 2025 (estimated)
- First posted
- 1 Jul 2024 (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 phase 1, randomized, First in Human (FIH), double-blinded, placebo-controlled study to assess the safety, tolerability, and PK of RSN0402 in healthy volunteers. A total of about 72 participants are expected to be enrolled.
Detailed description
This study consists of 3 parts. SAD Part: The participants in the SAD cohorts of the study (Cohort 1 to Cohort 5) will receive a single dose of RSN0402 at 2, 4, 8, 12, or 16 mg dose or placebo via inhalation using a dry powder inhalant. Participants from Cohort 2 will receive a single dose of 150 mg nintedanib soft capsule after 7-day washout period. After completion of Cohort 3, SRC will decide whether to enrol Cohort 4 sequentially or to skip Cohort 4 and enrol Cohort 5 directly based on the safety and PK data collected from the Cohort 1 to Cohort 3. If there are no safety concerns, Cohort 5 will be enrolled after Cohort 3.
MAD Part: The MAD Part consists of 4 cohorts with 8 participants in each cohort. Participants will be randomly assigned to receive RSN0402 (4, 8, 12, or 16 mg) or placebo for 7 days at a ratio of 3:1. In MAD study, the IP will be administered once daily from Day 1 to Day 7. The doses in MAD Part of the study could be adjusted at the discretion of the SRC based on the review of data from the SAD cohorts. The dose regimen in MAD Part may also be adjusted to twice daily or another regimen if there is any concern after SRC review of the available data from SAD cohorts. The adjusted dose and dose regimen cannot exceed the maximum safety daily dose confirmed in the SAD Part.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RSN0402 Part 1 | Experimental | Drug: RSN0402 Part 1Part 1 is SAD with 5 cohorts (1 to 5) where each participant will receive single dose of RSN0402 powder for inhalation or placebo following a 10hour fast. Cohort 2 will also receive single dose of nintedanib oral soft capsule. |
| RSN0402 Part 2 | Experimental | Drug: RSN0402 Part 2Part 2 is MAD with 4 cohorts (6 to 9) where each participant will receive multiple doses powder for inhalation or placebo following a 10 hr fast. |
| Placebo | Placebo comparator | Drug: PlaceboMatching doses of placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participant is overtly healthy or has no clinically significant condition as determined by PI/Sub-Investigator including medical history, vital signs, ECG, laboratory tests, and physical examination at Screening and admission (Day -2 and Day -1).
- Participant has normal lung function assessment with FEV1 of at least 80% of the predicted value and FEV1/FVC ratio of > 0.7 measured at Screening.
- Availability to participate voluntarily for the entire study duration and willing to adhere to all protocol requirements.
- Participant must be 18 to 60 years of age inclusive, at the time of signing the informed consent.
- Male participant with body weight of ≥ 50.0 kg, female participant with body weight ≥ 45.0 kg; males or females with body mass index (BMI) of ≥ 18 to < 30.0 kg/m² at screening.
Key exclusion criteria (30 listed)
- Vulnerable participants (ie, people under any administrative or legal supervision).
- Clinical laboratory evidence or clinical diagnosis of human immunodeficiency virus (HIV) infection, hepatitis C virus (HCV) infection, or chronic hepatitis B virus (HBV) infection (as shown by hepatitis B surface antigen [HbsAg] positivity).
- Evidence of a clinically significant cardiovascular, renal, hepatic, hematological, gastrointestinal (GI), pulmonary, metabolic-endocrine, neurological, or psychiatric disease or psychiatric disease within the previous 2 years; or evidence of active airway infection.
- Known hypersensitivity to the active substance(s) of the drug or its excipient (lactose monohydrate, which contains small amounts of milk protein) and/or intolerance with lactose.
- History of vasovagal syncope in past 5 years.
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 |
|---|---|---|
| RSN0402 Part 1Participants will receive single ascending doses of 2mg, 4mg, 8mg, 12 mg, and 16mg of RSN0402 or placebo on Day 1 for Cohort 1 to 5. Cohort 2(4mg) will also a single dose of 150 mg nintedanib soft capsule will be administered orally after at least 7-days washout period. | Drug | RSN0402 Part 1 |
| RSN0402 Part 2Participants will receive multiple ascending doses of 4mg ,8mg,12mg ,16mg of RSN0402 or placebo administered once daily from Day 1 to Day 7 for Cohort 6 to 9. | Drug | RSN0402 Part 2 |
| PlaceboParticipants will receive matching placebo across Part 1 and Part 2 of the study. | Drug | Placebo |
Primary outcome
Number of participants with Treatment emergent Adverse events (TEAEs)
Time frame: SAD - From Screening to Day 14 (end of study); MAD - From Screening to Day 13 (end of study)
TEASs will be collected to assess participant's safety after RSN0402 administration in both Single ascending dose (SAD) and multiple ascending dose (MAD).
Number of participants with changes in physical examination
Time frame: SAD- From Screening to Day 14 (end of study) post dose; MAD - At screening, Day -2, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 13 (end of study) post dose.
Full physical examination will comprise a routine medical examination including examination of head, eyes, ears, nose, throat and neck, abdomen, the respiratory system, central and peripheral nervous system, cardiovascular system, gastrointestinal system including mouth, musculoskeletal system, and skin. Brief physical examination will include at a minimum, assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen).
Number of participants with changes in serum blood parameters
Time frame: SAD- At Screening, Day -2, Day 3, Day 7, Day 10 and Day 14 (end of study) post dose; MAD- At Screening, Day -2, Day 3, Day 6, Day 9 and Day 13 (end of study) post dose.
Serum blood parameters include hematology, biochemistry, coagulation
Number of participants with changes in Urine parameters
Time frame: SAD: Urine pregnancy test will be conducted on Day -2 and Day 7 and Urine cotinine test in screening, Day -2 and Day 7 post first dose. MAD: Urine pregnancy test will be conducted on Day -2, Urine cotinine test in screening and Day -2.
Urine cotinine test and urine pregnancy test will be assessed
Number of participants with changes in vital signs
Time frame: SAD- At Screening, Day-2, Day 1, Day 2, Day 3, Day 7, Day 8, Day 9, Day 10 and Day 14 (end of study) post dose; MAD - At screening, Day - 2, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 13 (end of study) post dose.
Heart rate, systolic/diastolic blood pressure, respiratory rate, oxygen saturation, and temperature
Number of participants with change in Absolute Forced Expiratory Volume in 1 second (FEV1) >10%
Time frame: SAD- At Screening, Day -2, Day 1, Day 2, Day 3, Day 7, Day 8, Day 9, Day 10 and Day 14 (end of study) post dose; MAD - At screening, Day- 2, Day 1, Day 3, Day 6, Day 9 and Day 13 (end of study) post dose.
Spirometry will be conducted in accordance with ATS and ERS guidelines
13 secondary outcomes
Changes in AUC 0-inf (Area under curve from time 0 to infinity) of RSN0402 with 5 different doses of SAD.PK samples are collected at total of 17 time points from pre-dose and up to 48 hours after dosing on Day 3.
Time frame: SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10 post first dose; MAD- Day 1 to Day 9 post dose
PK parameter: Changes in AUC 0-t (Area under curve from time 0 to last measurable concentration) of RSN0402.
Time frame: SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
PK parameter: Changes in Cmax (Maximum observed plasma concentration) of RSN0402
Time frame: SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
PK parameter: Changes in Tmax (Time to Maximum) of RSN0402
Time frame: SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
PK parameter: Changes in t1/2 (Apparent terminal elimination half-life) of RSN0402
Time frame: SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
PK parameter: Changes in CL/F (Apparent systemic clearance) of RSN0402
Time frame: SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
PK parameter: Changes in Vz/F (Apparent volume of distribution) of RSN0402
Time frame: SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
PK parameter: Changes in AUCτ(Area under curve) of RSN0402
Time frame: SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
PK parameter: Changes in Cmax,ss (Cmax at steady state) of RSN0402
Time frame: SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
PK parameter: Changes in Ctrough (trough concentration) of RSN0402
Time frame: SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
PK parameter: Changes in Tmax,ss (Tmax at steady state) of RSN0402
Time frame: SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
PK parameter: Changes in Vss/F (Apparent steady state volume of distribution) of RSN0402
Time frame: SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
PK parameter: Change from Baseline in QT interval corrected by Fridericia's formula (QTcF)
Time frame: SAD - At Screening, Day-2, Day 1, Day 2, Day 3 and Day 7 (end of study) post dose; MAD - At screening, Day 2, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 13 (end of study) post dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RSN0402 Part 1 and RSN0402 Part 2 in people with Idiopathic Pulmonary Fibrosis and Lung; Disease, Interstitial, With Fibrosis, run by Shenzhen Resproly Biopharmaceutical Co., Ltd at 3 sites in Australia.
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 7 inclusion and 30 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 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. 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 Yiqing Cui (+86 13383111601, yiqing.cui@novotech-cro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Treatment emergent Adverse events (TEAEs) (time frame: SAD - From Screening to Day 14 (end of study); MAD - From Screening to Day 13 (end of study)). 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?
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 8 Jul 2024.