A Randomized, Blinded, Placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT001 in HVs and AD Patient
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:
• Age of 18-65 years.
• Body mass index between 18-28 kg/m², capped at 120 kg.
• Negative pregnancy tests for women of childbearing potential.
• Willingness to refrain from alcohol consumption for 24 hours prior to each study visit.
• Non-smokers, healthy current smokers (≤5 cigarettes/day), or ex-smokers.
• Adequate contraception use (for men and women of childbearing potential).
• No clinically significant abnormalities or history of relevant diseases.
• Must have dermatologist-confirmed chronic atopic dermatitis (≥12 months). Inadequate response to topical treatments or where they are medically inadvisable.
• Moderate to severe atopic dermatitis
• Validated investigator's global assessment for atopic dermatitis (vIGA-ADTM) score ≥3
• Atopic lesions cover ≥10% of body surface area (BSA)
• Average peak pruritus numeric rating scale (PP-NRS) score ≥4 in the 7 days before randomization.
• Eczema Area and Severity Index (EASI) score ≥16 at screening and randomization visits.
Locations
Other Locations
China
Peking University People's Hospital
NOT_YET_RECRUITING
Beijing
The Second Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
Dermatology Hospital of Southern Medical University
NOT_YET_RECRUITING
Guangzhou
The Second Hospital of Anhui Medical Univesity
RECRUITING
Hefei
Shandong Provincial Hospital for Skin Diseases
NOT_YET_RECRUITING
Jinan
Jiangxi Provincial Dermatology Hospital
NOT_YET_RECRUITING
Nanchang
Shanghai Dermatology Hospital
NOT_YET_RECRUITING
Shanghai
The Second Affiliated Hospital of Wannan Medical College
NOT_YET_RECRUITING
Wuhu
Wuxi Second People's Hospital
NOT_YET_RECRUITING
Wuxi
Jiangsu University Affiliated Hospital
NOT_YET_RECRUITING
Zhenjiang
Contact Information
Primary
Tracy Ji
tracy.ji@bambusatx.com
+86 18001322760
Time Frame
Start Date:2025-08-09
Estimated Completion Date:2027-03-26
Participants
Target number of participants:63
Treatments
Experimental: Part A -BBT001(Single Ascending Dose)
A single dose of BBT001 will be administered in healthy volunteers
Experimental: Part A- Placebo(Single Ascending Dose)
A single dose of Placebo will be administered in healthy volunteers
Experimental: Part B- BBT001(Multiple Ascending Dose)
Seven repeat doses of BBT001 will be administered in patients with moderate to severe atopic dermatitis
Experimental: Part B -Placebo (Multiple Ascending Dose))
Seven repeat doses of Placebo will be administered in patients with moderate to severe atopic dermatitis