Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001132336p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
11/08/2026
Date registered
Help: Date registered
11/09/2026
Date last updated
Help: Date last updated
11/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
11/09/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
A Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending and Multiple-Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Immunogenicity of WIN027 in Healthy Adult Participants
Scientific title
A Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending and Multiple-Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Immunogenicity of WIN027 in Healthy Adult Participants
Additional trial identifiers [1] 318080 0
WB-1201
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Asthma 343099 0
Chronic Obstructive Pulmonary Disease 343100 0
Condition category
Condition code
Respiratory 339188 339188 0 0
Asthma
Respiratory 339189 339189 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The study drug WIN027 is given as a subcutaneous (SC) injection either as a single dose or once weekly for 4 doses.
The study has 3 sequential cohorts, with participants receiving either WIN027 or placebo.
Cohort 1: 450 mg (single dose on Day 1).
Cohort 2: (single dose on Day 1) specific dose to be determined after review of Cohort 1 by the Safety review committee (SRC) but maximum dose to not exceed 900mg per day.
Cohort 3: specific dose to be determined after review of Cohort 2 by the Safety review committee (SRC) but maximum dose to not exceed 900mg per day, administered once weekly for 4 doses (on Days 1, 8, 15 and 22).
Participants will be dosed as in-patients and adherence will be monitored by site staff.
Intervention code [1] 334958 0
Treatment: Drugs
Description of the comparator or control
Placebo - SC injections, matching in appearance to WIN027 without any active study drug.
Control group
Placebo

Outcomes
Primary outcome [1] 346434 0
To assess the safety and tolerability of WIN027 in healthy adult volunteers. Safety and tolerability will be assessed as a composite primary outcome.
Timepoint [1] 346434 0
Adverse Events will be assessed at all visits from screening,everyday on Days -1, to 2, Day 5, 8, 15, 29, 57, 85, 141, 197 and 254 post-intervention commencement for Cohort 1 and 2. Cohort 3 participants will be assessed on Days -1, to 2, Day 5, 7, 8, 9, 12, 14, 15, 16, 19, 22, 26, 29, 57, 85, 141, 197, 226 and 275 post-intervention commencement.
Secondary outcome [1] 465836 0
To assess the pharmacokinetics of WIN027.
Timepoint [1] 465836 0
Blood samples for PK analysis will be collected on Day 1 (pre-dose and post-dose 4hrs), Day 2, 5, 8, 15, 29, 57, 85, 141, 197 and 254 for Cohorts 1 & 2. Blood samples for PK analysis will be collected on Day 1 (pre-dose and post-dose 4hrs), Day 2, 5, 8 (pre-dose and post-dose 4hrs), 9, 12, 15 (pre-dose and post-dose 4hrs), 19, 22 (pre-dose and post-dose 4hrs), 23, 26, 29, 57, 85, 141, 197, 226 and 275 for Cohort 3.

Eligibility
Key inclusion criteria
Participants must:
1. Be aged 18-65 (inclusive) years.
2. Sign the informed consent form (ICF).
3. Have a body mass index in the range of 18 to 35 kg/m2.
4. Medically healthy without clinically significant abnormalities (in the opinion of the Investigator).
5. Female participants and capable of becoming pregnant, have a negative pregnancy test at Screening and must agree to use a highly effective method of contraception from 28 days prior to screening till 36 weeks after last dose of study drug.
6. Male participants and of reproductive potential with sexual partner(s) of childbearing potential, must agree to use a highly effective form of birth control from signing of consent form and till 36 weeks after last dose of study drug.
7. Male participants must not donate or cryopreserve sperm or attempt to father a child, and female participants must not donate or cryopreserve ova, from Visit 1 until at least approximately 36 weeks after the last dose of study drug.
8. Test negative for Hepatitis B, Hepatitis C and HIV at Screening visit.
9. Be able and willing to comply with all study assessments and adhere to the protocol.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
Participants must not:
1. Be pregnant or breastfeeding female, or any plan for pregnancy or breastfeeding during the contraception window.
2. Prior receipt of drugs such as Tezepelumab, tralokinumab, lebrikizumab or dupilumab.
3. Known history of hypersensitivity or anaphylaxis to any biologic agent or to any of the study drug ingredients or history of documented immune-complex disease or vasculitis.
4. Acute or chronic infection requiring systemic anti-infective therapy within 2 weeks prior to Screening, or superficial skin infection within 1 week prior to Dosing.
5. Known helminth or other endoparasitic infection within 24 weeks of Visit 1 that has not been treated or has not responded to standard-of-care therapy.
6. Treatment for active tuberculosis within the 12 months prior to Visit 1.
7. Known primary or acquired immunodeficiency, or history of invasive opportunistic infection.
8. Presence or evidence of recent sunburn, scar tissue, tattoos, or open sores that, in the opinion of the investigator, would interfere with evaluation of the participant’s response to the study drug.
9. Any history of malignant disease in the last 5 years.
10. Known or pre-existing clinically significant cardiovascular, endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, hematological, pulmonary, or any other organ or system abnormality that is uncontrolled with standard treatment or, in the opinion of the Investigator and/or Medical Monitor, may compromise participant safety or interfere with evaluation of the trial drug.
11. Major surgery within 3 months prior to Screening or planned during the trial.
12. Have receipt of any marketed biologic agent within 4 months prior to Visit 1; receipt of immunoglobulin or blood products within 30 days prior to Visit 1; receipt of any live or attenuated vaccines within 30 days prior to Visit 1 and through the end of the trial.
13. Receiving an investigational drug in another clinical trial within 30 days prior to Visit 1.
14. Receipt of any prescription medication (including herbal/traditional medicines and dietary supplements) within 2 weeks prior to first dose or planned during the trial.
15. Donation of blood within 30 days prior to first dose of study drug.
16. Smoke more than 5 cigarettes or equivalent nicotine-containing products per week, and/or be unwilling to abstain from smoking or the use of nicotine-containing products for 72 hours prior to check-in on Day -1 and throughout the confinement period at the study site.
17. Regular consumption of more than 10 standard alcoholic drinks/week and/or more than 4 standard alcoholic drinks on any one day.
18. Current or recent (within 5 years prior to Screening) substance use disorder; use of narcotics, cocaine, amphetamines and other recreational drugs with abuse potential within 3 months prior to Screening.
19. Clinically significant abnormality on Electrocardiogram at Visit 1.
20. Concurrent enrolment in another clinical trial involving an investigational interventional treatment.

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)
An authorised, trained staff member from the site pharmacy will dispense the study drugs according to pre-defined drug dispensing requirements. Study drug will be dispensed according to assigned randomisation number, and Study drug vial dispensed should match the randomisation number. As the study is double-blinded, sealed participant-specific code break envelopes will be produced by the unblinded statistician(s) and will be retained at the study site in a secure, accessible location.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned in a 3:1 ratio (Cohort 1 & 2) or 4:1 (Cohort 3) to receive WIN027 or placebo and will be documented in the study randomisation schedule. Sequence will be generated using permuted block randomisation.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/10/2026
Actual
Date of last participant enrolment
Anticipated
13/01/2027
Actual
Date of last data collection
Anticipated
14/10/2027
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 29945 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 46308 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 322640 0
Commercial sector/Industry
Name [1] 322640 0
Windward Bio 27 AG
Country [1] 322640 0
Switzerland
Primary sponsor type
Commercial sector/Industry
Name
Windward Bio 27 AG
Address
Country
Switzerland
Secondary sponsor category [1] 325562 0
Commercial sector/Industry
Name [1] 325562 0
Avance Clinical Pty Ltd
Address [1] 325562 0
Country [1] 325562 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 321098 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 321098 0
Ethics committee country [1] 321098 0
Australia
Date submitted for ethics approval [1] 321098 0
29/07/2026
Approval date [1] 321098 0
Ethics approval number [1] 321098 0

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

Contacts
Principal investigator
Name 152658 0
Dr Natasha Martin
Address 152658 0
CMAX Clinical Research Pty Ltd, Ground Floor, 21-24 North Terrace, Adelaide, South Australia, 5000
Country 152658 0
Australia
Phone 152658 0
+61 870887900
Fax 152658 0
Email 152658 0
[email protected]
Contact person for public queries
Name 152659 0
Ciaran Murphy
Address 152659 0
Windward Bio AG, Aeschenplatz 6 4052 Basel Switzerland
Country 152659 0
Switzerland
Phone 152659 0
+41615516060
Fax 152659 0
Email 152659 0
[email protected]
Contact person for scientific queries
Name 152660 0
Michael Larbig
Address 152660 0
Windward Bio AG, Aeschenplatz 6 4052 Basel Switzerland
Country 152660 0
Switzerland
Phone 152660 0
+41615517575
Fax 152660 0
Email 152660 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.