ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12625000865415

Ethics application status

Approved

Date submitted

23/07/2025

Date registered

11/08/2025

Date last updated

11/08/2025

Date data sharing statement initially provided

11/08/2025

Type of registration

Prospectively registered

Titles & IDs

Public title

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending and Multiple Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics, and pharmacodynamics of Inhaled SUN-001 in Healthy Volunteers

Scientific title

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Idiopathic pulmonary fibrosis

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The study is a randomized, double-blind, placebo-controlled, single and multiple ascending dose study of inhaled SUN-001 in healthy adult volunteers.
The study is comprised of two parts as follows:
*Part A – up to three planned and one optional, sequentially run, single ascending dose (SAD) cohorts
*Part B - up to two planned and one optional, sequentially run, multiple ascending dose (MAD) cohorts

The study will be initiated with the first SAD dose level cohort in Part A. The first MAD dose level cohort in Part B (Cohort B1) can commence after initiation of Part A, however, the dose of SUN-001 tested will not be greater than the highest dose that has been declared as safe and well tolerated by the study Safety Monitoring Committee (SMC), based on all available data and cumulative clinical experience with SUN-001.SUN-001 drug product is supplied as a sterile aqueous solution formulated for inhalation.

SUN-001 will be diluted in sterile normal saline (sodium chloride 0.9 percent) and administered via nebulization. The nebulizer is a small handheld device that produces a fine mist that is inhaled by mouth through a small mouthpiece, During this time, the participant will breathe normally. The duration of nebulization and dosing may vary depending on the participant’s respiratory rate and lung volume, but the total duration of inhalation procedure will not exceed 20 minutes.

A single dose of SUN-001 for SAD cohorts will be administered in the morning on Day 1. For MAD cohorts, SUN-001 will be administered once daily in the morning from Day 1 through Day 14. Every effort will be made to administer the drug at approximately the same time every day.

Part A of the study will evaluate up to three planned and one optional SAD cohorts (1 cohort per dose level). Eight participants will be enrolled into each cohort and randomly assigned to receive either placebo (n=2) or SUN-001 (n=6). The planned dose for cohort A1 is 0.6mg, with subsequent dose levels determined by the SMC.

The maximum dose for Part A is 1.2mg and the maximum dose of Part B is 1mg daily for 14 days.

Participants will only be able to participate once, in either Part A or Part B.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Placebo control.
The placebo is sterile normal saline (sodium chloride 0.9 percent) administered by nebulizer

Control group

Placebo

Outcomes

Primary outcome [1]

To assess the safety and tolerability of SUN-001 following inhaled administration of single and multiple ascending doses.

Timepoint [1]

Safety and tolerability will be assessed by the incidence and severity of all treatment emergent adverse events (TEAEs), collected and evaluated at each visit from the time of Investigational Medicinal Product (IMP) administration until the final follow-up visit on Day 28 (27 days post first dose for Part A) or Day 44 (41 to 43 days post first dose for Part B)

Primary outcome [2]

To assess the safety and tolerability of SUN-001 following inhaled administration of single ascending doses (Part A).

Timepoint [2]

Part A: The listed assessments will be performed at the following timepoints in Part A: screening (1 day prior to dosing), Day 1 (dosing day), Day 2 (1 day post-dose), Day 3 (2 days post-dose), Day 4 (3 days post dose), Day 14 (13 days post-dose), and Day 28 (27 days post-dose).

Primary outcome [3]

To assess the safety and tolerability of SUN-001 following inhaled administration of multiple ascending doses (Part B).

Timepoint [3]

Part B: Assessments will be conducted during the screening period (28 to 2 days prior to initial dosing), and repeated at baseline (1 day prior to initial dosing). Further assessments will occur on Day 1 (initial dosing), Day 2 (24 hours post-dose), daily from Day 3 to Day 13, and on Days 14, 15, 21, and 44.

Secondary outcome [1]

Additional Primary Outcome: To assess the safety and tolerability of SUN-001 following inhaled administration of single and multiple ascending doses (Part A).

Timepoint [1]

Part A: Assessments will be conducted during the screening period (28 to 2 days prior to dosing) and again at baseline (1 day prior to dosing). Additional assessments will be performed at baseline (1day prior to dose administration), on Day 1 (dosing day) pre-dose (within 2 hours prior to dosing), and at 60 minutes, 2 hours, 6 hours, and 24 hours post-dose (Day 2), following completion of the inhalation procedure. A final assessment will occur on Day 4 (3 days after dosing and prior to discharge from the unit).

Secondary outcome [2]

Additional Primary Outcome: To assess the safety and tolerability of SUN-001 following inhaled administration of single and multiple ascending doses (Part B).

Timepoint [2]

Part B: A 12-lead ECG will be performed during screening (28 to 2 days prior to initial dosing) and again on Day -1 (the day prior to initial dosing). Further assessments will be conducted on Day 1 (dosing day) pre-dose (within 2 hours prior to dosing), and at 60 minutes, 2 hours, 6 hours, and 24 hours post-inhalation, following completion of the inhalation procedure. Additional assessments will be performed on Day 3 (3 days post-initial dose), Day 7 (7 days post-initial dose), and Day 14 (14 days post-initial dose), with ECGs conducted at 60 minutes following the inhalation procedure at each of these visits.

Secondary outcome [3]

To assess the pharmacokinetic (PK) parameters of SUN-001 in plasma following inhaled administration of single and multiple ascending doses (Part A).

Timepoint [3]

For Part A, PK samples will be collected pre-dose (within 2 hours of dosing) and at 5, 15, 30 and 60 minutes, 2, 4, 6, 12 hours, Day 2 (24 hours) and Day 3 (48 hours) after completion of the inhalation procedure.

Secondary outcome [4]

To assess the pharmacokinetic (PK) parameters of SUN-001 in plasma following inhaled administration of single and multiple ascending doses (Part B).

Timepoint [4]

On Day 1 and Day7. PK samples will be collected at pre-dose (within 2 hours of dosing) and at 15, 30 and 60 minutes, 2-, 4-, 6- and 12-hours following completion of the inhalation procedure. On days 2 to 6, PK samples will be collected pre-dose (within 30 minutes of dosing). PK samples will be collected pre-dose (within 2 hours of dosing) and at 15, 30 and 60 minutes, 2-, 4-, 6- and 12-hours following completion of the inhalation procedure on Day 14, and in the case of early termination. On Day 15, a PK sample will be collected 24 hours following completion of the Day 14 inhalation procedure.

Secondary outcome [5]

To assess the pharmacodynamic (PD) effects of SUN-001 as measured by changes in mRNA of BRD4 target proteins (MYC, HEXIM1, CCR2, and CD180) in whole blood following inhaled administration of single ascending doses (Part A).

Timepoint [5]

Part A: Blood samples will be collected pre-dose (within 2 hours of dosing) on Day 1, at 24 hours (Day 2) and 48 hours (Day 3) after completion of the inhalation procedure for biomarker assessment.

Secondary outcome [6]

Timepoint [6]

Whole blood samples will be collected pre-dose (within 2 hours of dosing) on Day 1, Day 2, and Day 14 (and in the case of early termination), and at approximately the same time of day on Day 15 for biomarker assessment.

Secondary outcome [7]

To explore the PK-PD relationship of SUN-001

Timepoint [7]

This exploratory outcome will model data derived from both pharmacokinetic (PK) and pharmacodynamic (PD) assessments, as outlined below. Pharmacokinetic (PK) Assessments for part A: PK samples will be collected pre-dose (within 2 hours prior to dosing), and at 5, 15, 30, and 60 minutes, as well as at 2, 4, 6, and 12 hours post-dose. Additional samples will be collected at 24 hours (Day 2) and 48 hours (Day 3) following completion of the inhalation procedure. PD Assessments: Blood samples for biomarker assessment will be collected pre-dose (within 2 hours prior to dosing) on Day 1, and at 24 hours (Day 2) and 48 hours (Day 3) following completion of the inhalation procedure.

Secondary outcome [8]

To explore the PK-PD relationship of SUN-001

Timepoint [8]

This exploratory outcome will model data derived from both pharmacokinetic (PK) and pharmacodynamic (PD) assessments, as outlined below. Pharmacokinetic (PK) Assessments: On Days 1 and 7, PK samples will be collected pre-dose (within 2 hours prior to dosing), and at 15, 30, and 60 minutes, as well as 2, 4, 6, and 12 hours post-inhalation. On Days 2 to 6, samples will be collected pre-dose (within 30 minutes prior to dosing). On Day 14, and in the case of early termination, samples will be collected pre-dose (within 2 hours prior to dosing) and at 15, 30, and 60 minutes, and 2, 4, 6, and 12 hours post-inhalation. On Day 15, a single PK sample will be collected 24 hours following completion of the Day 14 inhalation procedure, PD Assessments: Whole blood samples for biomarker analysis will be collected pre-dose (within 2 hours prior to dosing) on Day 1, Day 2, and Day 14 (and at early termination, if applicable), and at approximately the same time of day on Day 15.

Eligibility

Key inclusion criteria

To be eligible for this study, a participant must meet all of the following criteria:
1. Healthy adults equal to or greater than 18 and equal to or less than 60 years (inclusive).
2. Forced Expiratory Volume in one second (FEV1) equal to or greater than 80% predicted at the screening visit.
3. Body Mass Index (BMI) equal to or greater than 18 and equal to or less than 32 kg/m^2 (inclusive).
4. Females must be non-pregnant and non-lactating, and must be
a) Surgically sterile (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before screening), or use highly effective contraceptive method (oral contraceptive pills [OCPs], long-acting implantable hormones, injectable hormones, a vaginal ring or an intrauterine device [IUD], or having undergone tubal occlusion at least 6 weeks prior to screening) and condom for male partner, from screening until study completion, including the follow-up period for at least 30 days after the last dose of study drug, or
b) Post-menopausal for equal to or greater than12 months. Post-menopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels (equal to or greater than40 IU/mL) at screening for amenorrheic female participants. Female participants who’s only partner has had a vasectomy (>30 days since vasectomy with no viable sperm), and female participants who are abstinent from heterosexual intercourse as part of their usual lifestyle will also be eligible for participation.
5. Women of childbearing potential (WOCBP) must agree to abstain from egg donation through 30 days after 5 half-lives of the study product have elapsed from the last dose of study drug.
6. Males must be:
a) Surgically sterile (>30 days since vasectomy with no viable sperm), abstinent, or their partner must be surgically sterile (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or if engaged in sexual relations with a WOCBP, the male participant and his partner must use an acceptable, highly effective contraceptive method from screening until study completion, including the follow-up period, for at least 90 days after the last dose of study drug. Acceptable methods of contraception include the use of condoms and the use of an effective contraceptive for the female partner (WOCBP) that includes: OCPs, long-acting implantable hormones, injectable hormones, a vaginal ring, an IUD or having undergone tubal occlusion at least 6 weeks prior to screening. Participants who are abstinent from heterosexual intercourse as part of their usual lifestyle will also be eligible.
7. Male participants must agree to refrain from donating sperm through 90 days after 5 half-lives of the study product have elapsed from the last dose of study drug.
8. Ability and willingness to comply with all protocol procedures and restrictions (e.g., compliance with visit schedule, nebulization, dietary requirements, alcohol restrictions, etc.).
9. Ability to provide written informed consent.

Minimum age

18 Years

Maximum age

60 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

A participant who meets any of the following criteria must be excluded from the study:
1. History of any significant pulmonary disease including, but not limited to, asthma (including exercise induced asthma, allergy-induced asthma, or any history of asthma diagnosis including resolved childhood asthma), chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, and history of previous tuberculosis exposure with positive interferon gold test (without actual infection). Recent history of pneumonia or respiratory tract infection (within 6 weeks of screening).
2. History of clinically significant (as per Principal Investigator's discretion) upper respiratory disease including, but not limited to, nasal polyps or Samter's Triad.
3. Diagnosis of gastro-esophageal reflux disease (GERD).
4. History of cardiovascular disease including, but not limited to, heart failure (New York Heart Association (NYHA) class II, III or IV), myocardial infarction, angina, transient ischemic attack, cerebral infarct or haemorrhage, or history of an invasive cardiovascular therapeutic procedure such as coronary angioplasty, stent implantation, Coronary Artery Bypass Graft (CABG), etc.
5. Presence of a clinically significant electrocardiogram (ECG) finding at any time prior to initial IMP dose (e.g., QTcF greater than 450 msec for males, QTcF greater than 470 msec for females, left bundle branch block (LBBB), significant cardiac arrhythmia).
6. History of anaphylaxis, severe allergies or confirmed drug hypersensitivity reactions.
7. Known diagnosis of prolonged QT interval, history of arrhythmias (with the exception of sinus bradycardia) or previous episode of syncope thought to be of cardiac origin, or a family history of congenital long QT syndrome or unexplained death.

8. If female, positive pregnancy test at screening or on admission to the Unit on Day -1, or breastfeeding, or planning to breastfeed during the study.
9. Unwillingness to refrain from strenuous physical activity (e.g., heavy lifting, weight or fitness training) from 72 hours prior to admission and each other study day where safety laboratory samples are collected.
10. Unwillingness to refrain from sunbathing or use of a sunbed during the study.
11. Consumption of foods and/or drinks with known modulation of Cytochrome P450 Enzyme (CYP) activity (e.g., grapefruit / Seville oranges/pomelo, quinine containing products or drinks [tonic water/bitter lemon]) from 5 days before dosing until the final PK sample is collected.
12. The presence of clinically significant physical examination (including vital signs) or laboratory findings at screening or baseline that, in the opinion of the Principal Investigator, may interfere with any aspect of study conduct or interpretation of results or place a participant at heightened risk.
13. History of renal disease or abnormal kidney function tests at screening (glomerular filtration rate [GFR] less than 60 mL/min/1.73m2 as estimated using the CKD-EPI equation).
14. Participants with a history of, or active, clinically significant disease that could interfere with the interpretation of the study results or compromise the health of the volunteer.
15. Participants with a history of, or active, chronic liver disease due to alcohol, auto-immune mechanisms, primary biliary cholangitis, human immunodeficiency virus (HIV), hepatitis B virus (HBV), or active hepatitis C virus (HCV)-infection, Wilson's disease, alpha-1-antitrypsin deficiency, hemochromatosis, or metabolic dysfunction-associated steatohepatitis (MASH) disease. Participants with Gilbert’s disease and/or cholecystectomy will not be excluded.
16. Significant psychiatric history (including bipolar disorder, major depression, anxiety requiring behavioural or medical therapy, suicidal behaviour) in the opinion of the Principal Investigator within 2 years of screening.
Approval of the Sponsor Medical Monitor should be sought for participants with a history of psychiatric disorders within 5 years prior to screening.
17. Abnormal laboratory results:
a) amylase and/or lipase greater than the Upper Limit of Normal (ULN) (elevated values may be repeated once on a separate day).
b) AST and/or ALT greater than ULN (elevated values less than 1.2 x ULN may be repeated once on a separate day).
c) platelet count less than 150,000/mm^3 (decreased counts equal to or greater than 120,000/mm^3 may be repeated once on a separate day).
d) Absolute eosinophil count greater than 1.5 x ULN (increased counts greater than 1.5 and less than 2.0 times the ULN may be repeated on a separate day).
18. Administration of vaccines/immunizations and/or boosters within 28 days prior to first dosing or if planned during the study.
19. Significant allergy to medical adhesive tape in the opinion of the Principal Investigator.
20. Use of any medications other than permitted contraceptives and hormone replacement therapy for post-menopausal women only (including prescription and non-prescription medications, and herbal supplements) within 14 days or 5 half-lives (whichever is longer) prior to admission to the Unit on Day -1, or an anticipated requirement for use of these during the study. Occasional use of paracetamol up to 4 g/day is permitted. Nutritional supplements may be permitted but must be discussed with the Sponsor Medical Monitor prior to participant enrolment.
21. History of, or suspected allergy or hypersensitivity to the investigational product components.
22. History of any active infection at the time of screening and/or within 28 days prior to first dosing.
24. Positive Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), Hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening.
25. Participation in any other clinical interventional study (including screening, dosing and follow-up) within 30 days or 5 half-lives prior to screening, whichever is longer. If clinical intervention was more than 6 months prior to screening and the participant is in follow-up only, eligibility may be assessed on a case-by-case basis in consultation with the Sponsor’s Medical Monitor.
26. Previous participation in a study with an investigational drug or device involving a biological targeted therapy, where final administration of the investigational drug or utilization of the device occurred within 24 weeks prior to first dosing.
27. Alcohol consumption greater than 14 units per week for men or greater than 7 units per week for women and/or positive alcohol breath test at screening and/or Day -1 (one unit is defined as 12 fluid ounces of regular beer (5 percent alcohol), 5 fluid ounces of wine (12 percent alcohol), or 1.5 fluid ounces of 80 proof (40 percent alcohol) distilled spirits).
28. Positive urine drug test at screening or on admission to the unit on Day -1.
29. Use of any tobacco and/or nicotine and/or inhaled marijuana product within 2 years prior to screening.
30. Use of non-nicotine-containing vaping product within 6 months prior to screening.
31. Existence of any surgical or medical condition that, in the judgement of the Principal Investigator, might interfere with the absorption, distribution, metabolism, or excretion of the investigational product.
32. Any anticipated upper respiratory, pulmonary, or abdominal procedures (e.g., surgery), that might interfere with the compliance or completion of the study.
33. Donation (or loss) of 470 mL or more whole blood during the 56 days prior to first dosing, or donation of plasma or platelets during the 14 days prior to first dosing, and/or plan to donate whole blood, plasma or platelets within 4 weeks after the last study-related blood draw.

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)

Once deemed eligible for study participation, the participant will be enrolled and (where applicable) assigned a sequential randomization number based on a randomization schedule generated by the study statistician. The randomization schedule will be provided to the unblinded study pharmacist. Participants will receive a randomization number prior to the inhalation of the study drug.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

A sequential randomization schedule is to be generated by the study statistician.

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

Intervention assignment

Other design features

Phase

Phase 1

Type of endpoint/s

Safety

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

26/08/2025

Actual

Date of last participant enrolment

Anticipated

9/12/2025

Actual

Date of last data collection

Anticipated

21/01/2026

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

CMAX Clinical Research Pty Ltd - Adelaide

Recruitment postcode(s) [1]

5000 - Adelaide

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Sunterra Bio

Address [1]

Country [1]

United States of America

Primary sponsor type

Commercial sector/Industry

Name

Sunterra Bio

Address

Country

United States of America

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bellberry Human Research Ethics Committee C

Ethics committee address [1]

https://bellberry.com.au/

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/06/2025

Approval date [1]

22/07/2025

Ethics approval number [1]

Summary

Brief summary

SUN-001 is a drug being developed as a potential treatment for idiopathic pulmonary fibrosis (IPF). IPF is a chronic progressive Interstitial Lung Disease, the cause of which is unknown. IPF is associated with declining lung function and progressive respiratory failure.
SUN-001 is expected to slow fibrosis progression and improve clinical outcomes in patients with IPF.

In this study, we will look at the safety and tolerability of SUN-001. This study will also determine the levels of SUN-001 in the bloodstream when SUN-001 is given by nebuliser.

Trial website

Trial related presentations / publications

Public notes

Positive COVID-19 and/or influenza point of care rapid test on Day -1 would be exclusionary to participation in this trial.

Contacts

Principal investigator

Name

Prof Sepehr Shakib

Address

CMAX Clinical Research, Ground Floor, 21-24 North Terrace, Adelaide, South Australia, 5000

Country

Australia

Phone

+61 8 7088 7900

Fax

[email protected]

Contact person for public queries

Name

Dr Srikanth Pendyala

Address

Sunterra Bio, 2712 Loker Avenue West #1220, Carlsbad, California 92010

Country

United States of America

Phone

+1 650 580 9025

Fax

[email protected]

Contact person for scientific queries

Name

Dr Srikanth Pendyala

Address

Sunterra Bio, 2712 Loker Avenue West #1220, Carlsbad, California 92010

Country

United States of America

Phone

+1 650 580 9025

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

No
No IPD sharing reason/comment: The sponsor reserves the right to withhold data for the intended purposes outlined in the HREC approved protocol while maintaining compliance with local regulations and ICH GCP.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically