This is a Phase 1, randomized, blinded, placebo controlled, single ascending dose (SAD) study of BBT001 in healthy volunteers (HVs) and adult patients with moderate to severe Atopic Dermatitis (AD).
The study consists of two parts: Part A (single dose in HVs in sequential ascending dose cohorts, SAD in HVs part) Part B (seven repeated doses in patients with moderate to severe AD, multiple ascending Dose in patients part)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
63
The Second Hospital of Anhui Medical Univesity
Hefei, Anhui, China
RECRUITINGThe Second Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
NOT_YET_RECRUITINGNumber of participants with adverse events following single and multiple administration of BBT001
Incidence, relatedness, and severity of adverse events graded per NCI CTCAE v5.0.
Time frame: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration
Number of participants with change in vital sign measurements following treatment administration.
Blood pressure and heart rate will be assessed.
Time frame: Part A- Up to Day 141; Part B-Up to Day 169 post first dose administration
Number of participants with change in serum blood parameters.
Laboratory assessments include hematology, blood chemistry and coagulation test
Time frame: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration
Number of participants with change in physical examination following treatment administration.
Physical examination will be assessed.
Time frame: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration
Number of participants with change in 12-lead electrocardiogram (ECG) results measurements following treatment administration.
12-lead ECG will be tested at individual sites using sites' equipment and will be assessed.
Time frame: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration
Pharmacokinetics parameters- maximum observed Concentration (Cmax)
Maximum observed concentration of the study drug in serum will be analyzed for all subjects.
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Peking University People's Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGDermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGThe Second Xiangya Hospital of Central South University
Changsha, Hunan, China
NOT_YET_RECRUITINGWuxi Second People's Hospital
Wuxi, Jiangsu, China
NOT_YET_RECRUITINGJiangsu University Affiliated Hospital
Zhenjiang, Jiangsu, China
NOT_YET_RECRUITINGJiangxi Provincial Dermatology Hospital
Nanchang, Jiangxi, China
NOT_YET_RECRUITINGShandong Provincial Hospital for Skin Diseases
Jinan, Shandong, China
NOT_YET_RECRUITINGShanghai Dermatology Hospital
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGPharmacokinetics parameters- Time for maximum observed Concentration (Tmax)
Serum PK Tmax will be analyzed for all subjects
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
Pharmacokinetics parameters- Area under the curve (AUC)
Area under the curve of the study drug in serum will be analyzed for all subjects
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
Pharmacokinetics parameters- Volume of distribution (Vz)
Volume of distribution of the study drug in serum will be analyzed for all subjects
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
Pharmacokinetics parameters- Total clearance (CL)
Total clearance of the study drug in serum will be analyzed for all subjects
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
Pharmacokinetics parameters- - Elimination Half-life (t1/2).
Elimination half-life of the study drug in serum will be analyzed for all subjects
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
The immunogenicity of BBT001 is measured as the number and percentage of subjects who develop Anti-Drug Antibodies (ADA).
Serum Anti-Drug Antibodies will be analyzed for all subjects
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration