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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06482190




Registration number
NCT06482190
Ethics application status
Date submitted
25/06/2024
Date registered
1/07/2024
Date last updated
8/07/2024

Titles & IDs
Public title
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of RSN0402 in Healthy Volunteers
Scientific 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
Secondary ID [1] 0 0
RES-RSN0402-P1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis 0 0
Lung; Disease, Interstitial, With Fibrosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RSN0402 Part 1
Treatment: Drugs - RSN0402 Part 2
Treatment: Drugs - Placebo

Experimental: RSN0402 Part 1 - 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.

Experimental: RSN0402 Part 2 - 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.

Placebo comparator: Placebo - Matching doses of placebo


Treatment: Drugs: RSN0402 Part 1
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.

Treatment: Drugs: RSN0402 Part 2
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.

Treatment: Drugs: Placebo
Participants will receive matching placebo across Part 1 and Part 2 of the study.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with Treatment emergent Adverse events (TEAEs)
Timepoint [1] 0 0
SAD - From Screening to Day 14 (end of study); MAD - From Screening to Day 13 (end of study)
Primary outcome [2] 0 0
Number of participants with changes in physical examination
Timepoint [2] 0 0
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.
Primary outcome [3] 0 0
Number of participants with changes in serum blood parameters
Timepoint [3] 0 0
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.
Primary outcome [4] 0 0
Number of participants with changes in Urine parameters
Timepoint [4] 0 0
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.
Primary outcome [5] 0 0
Number of participants with changes in vital signs
Timepoint [5] 0 0
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.
Primary outcome [6] 0 0
Number of participants with change in Absolute Forced Expiratory Volume in 1 second (FEV1) >10%
Timepoint [6] 0 0
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 outcome [1] 0 0
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.
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
PK parameter: Changes in AUC 0-t (Area under curve from time 0 to last measurable concentration) of RSN0402.
Timepoint [2] 0 0
SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
Secondary outcome [3] 0 0
PK parameter: Changes in Cmax (Maximum observed plasma concentration) of RSN0402
Timepoint [3] 0 0
SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
Secondary outcome [4] 0 0
PK parameter: Changes in Tmax (Time to Maximum) of RSN0402
Timepoint [4] 0 0
SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
Secondary outcome [5] 0 0
PK parameter: Changes in t1/2 (Apparent terminal elimination half-life) of RSN0402
Timepoint [5] 0 0
SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
Secondary outcome [6] 0 0
PK parameter: Changes in CL/F (Apparent systemic clearance) of RSN0402
Timepoint [6] 0 0
SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
Secondary outcome [7] 0 0
PK parameter: Changes in Vz/F (Apparent volume of distribution) of RSN0402
Timepoint [7] 0 0
SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
Secondary outcome [8] 0 0
PK parameter: Changes in AUCt(Area under curve) of RSN0402
Timepoint [8] 0 0
SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
Secondary outcome [9] 0 0
PK parameter: Changes in Cmax,ss (Cmax at steady state) of RSN0402
Timepoint [9] 0 0
SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
Secondary outcome [10] 0 0
PK parameter: Changes in Ctrough (trough concentration) of RSN0402
Timepoint [10] 0 0
SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
Secondary outcome [11] 0 0
PK parameter: Changes in Tmax,ss (Tmax at steady state) of RSN0402
Timepoint [11] 0 0
SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
Secondary outcome [12] 0 0
PK parameter: Changes in Vss/F (Apparent steady state volume of distribution) of RSN0402
Timepoint [12] 0 0
SAD-Day 1, Day 2, Day 3, Day 8, Day 9 and Day 10; MAD- Day 1 to Day 9 post dose
Secondary outcome [13] 0 0
PK parameter: Change from Baseline in QT interval corrected by Fridericia's formula (QTcF)
Timepoint [13] 0 0
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

Eligibility
Key inclusion criteria
1. 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).
2. 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.
3. Availability to participate voluntarily for the entire study duration and willing to adhere to all protocol requirements.
4. Participant must be 18 to 60 years of age inclusive, at the time of signing the informed consent.
5. 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.
6. 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.
7. 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.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Vulnerable participants (ie, people under any administrative or legal supervision).
2. 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).
3. 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.
4. 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.
5. History of vasovagal syncope in past 5 years.
6. History of anaphylactic/anaphylactoid reactions.
7. History of seizures including febrile seizures.
8. History of bleeding disorders or currently being treated with anticoagulants or regular using aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).
9. History of thrombotic event (including stroke and transient ischemic attack) within 6 months prior to Screening.
10. History of pulmonary arterial hypertension.
11. 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
12. Surgery of the GI tract (except appendectomy or simple hernia repair).
13. 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.
14. 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.
15. 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.
16. Administration of another investigational drug within the past 30 days prior to the first dose of IP.
17. 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.
18. 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
19. Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) > 1.5 x upper limit of normal (ULN) or total Bilirubin > 1.5 x ULN.
20. Pregnant or lactating females.
21. 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.).
22. Participants with a positive result of drug abuse test or with a history of drug abuse at Screening.
23. 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.
24. 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.
25. 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.
26. Blood donation or loss of significant amount (= 200 mL) of blood within 30 days prior to the first dose of IP administration.
27. Unsuitable veins for repeated venipuncture or for cannulation.
28. Inability to learn the correct inhalation technique.
29. Predictable poor compliance.
30. Judged to be not eligible by the Investigator/Sponsor for any other reason

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
11/07/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/02/2025
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Geelong
Recruitment hospital [2] 0 0
Nucleus Network - Melbourne
Recruitment hospital [3] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
3220 - Geelong
Recruitment postcode(s) [2] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Shenzhen Resproly Biopharmaceutical Co., Ltd
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Resproly Australia Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Yiqing Cui
Address 0 0
Country 0 0
Phone 0 0
+86 13383111601
Fax 0 0
Email 0 0
yiqing.cui@novotech-cro.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06482190