None listed
Conditions
Brief summary
This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled, sequential single-ascending-dose (SAD) followed by multiple-dose (MD) trial in healthy adult participants aged between 18 and 65 years old. Participants will be enrolled into 1 of 3 cohorts – each cohort testing a different dose of the study drug WIN027. Participants will be dosed as in-patients at the study site and then will be followed up with multiple follow-up visits over a period of 36 weeks. The study drug WIN027 is being developed for the treatment of moderate-to-severe uncontrolled asthma and chronic obstructive pulmonary disease.
Interventions
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 Safet
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.
Sponsors
Windward Bio 27 AG
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
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.
Outcome results
None listed