None listed
Conditions
Brief summary
The purpose of this study is to find out if BEL536is safe and tolerable in healthy adults. BEL536 is a synthetic protein called a bispecific antibody which can recognise and block pathways to help reduce inflammatory responses in the body. Bispecific means that BEL536 can attach to two different targets at the same time. This is the first time BEL536 has been tested in humans and aims to assess the effects of BEL536 on healthy volunteers.
Interventions
Study drug BEL536 will be administered to healthy adults by subcutaneous injection. The study includes a SAD phase in Part A and a MAD phase in Part B. In Part A, approximately 24 participants will be enrolled in three cohorts of approximately 8 healthy participants each, randomized 3:1 to receive a single subcutaneous dose of BEL536 (150 mg, 450 mg, or 1200 mg) or placebo. In Part B, approximately 16 participants will be enrolled in two cohorts of approximately 8 healthy participants each, rand
Study drug BEL536 will be administered to healthy adults by subcutaneous injection. The study includes a SAD phase in Part A and a MAD phase in Part B. In Part A, approximately 24 participants will be enrolled in three cohorts of approximately 8 healthy participants each, randomized 3:1 to receive a single subcutaneous dose of BEL536 (150 mg, 450 mg, or 1200 mg) or placebo. In Part B, approximately 16 participants will be enrolled in two cohorts of approximately 8 healthy participants each, randomized 3:1 to receive three subcutaneous doses of BEL536 (300 mg or 750 mg) or placebo over a 29-day period, with each dose administered 14 days apart. Participants will be confined to the study site on the dosing days to ensure adherence to assessments. Study medication is administered by qualified delegated site personnel
Sponsors
Belenos Biosciences, Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Ability to understand and comply with study-related requirements and restrictions listed in the consent form and voluntarily sign the ICF. 2. Male or female participants who, at the time of signing the ICF, are ages 18 to 55 years 3. Good health status is defined as no clinically relevant abnormalities based on medical history, physical examination, vital signs, 12-lead ECGs, and laboratory test results as assessed by the Investigator during the screening period. 4. Body mass index (BMI) between 18.0 and 30.0 kg/m² and a total body weight >50 kg
Exclusion criteria
1. Severe trauma or major surgery within 3 months prior to screening. 2. Infection requiring systemic treatment with antibiotics, antivirals, antiparasitic, antiprotozoals, or antifungals within 4 weeks prior to screening. 3. Any chronic or serious disease of the musculoskeletal, neuropsychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, urinary, or reproductive system, as assessed by the Investigator. 4. Skin depression, induration, scarring, inflammation, edema, ulceration, infection, bleeding, or any other condition deemed unsuitable for SC injection by the Investigator at the intended injection site 5. History of malignancies within 5 years prior to screening, except for a history of localized basal cell or squamous cell skin cancer provided the participant is cancer-free at Screening. 6. Participation in any investigational clinical study of drugs or medical devices within 3 months or within 5 half-lives for drugs (whichever is longer) prior to screening. Average daily smoking of 5 or more cigarettes within 3 months prior to screening. 7. Daily consumption of more than 5 cups of strong tea, coffee, and/or caffeinated beverages within 3 months prior to screening. 8. Blood loss (excluding plasma donations) exceeding 550 mL within 60 days prior to dosing, due to donation or other reasons. 9. Individuals deemed unsuitable for participation in a clinical study or unable to complete the study for other reasons by the Investigator. 10. Pregnant or breastfeeding female participants, or male or female participants pursuing artificial reproductive technologies, including but not limited to sperm/egg donation 11.Participants who are do not meet the relevant contraceptive requirements 12. Participants not meeting the diagnostic assessment criteria as per study protocol
Outcome results
None listed