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 Patients
Status: Recruiting
Location: See all (7) 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) and multiple ascending dose (MAD) 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 18-32 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.
Locations
United States
New York
Equity Medical, LLC
NOT_YET_RECRUITING
The Bronx
Other Locations
Australia
Linear Clinical Research
RECRUITING
Perth
New Zealand
Optimal Clinical Trials Ltd - Christchurch
NOT_YET_RECRUITING
Christchurch Central City
Optimal Clinical Trials Central Auckland
RECRUITING
Grafton
Aotearoa Clinical Trials
RECRUITING
Otahuhu
Pacific Clinical Research Network (PCRN) - Auckland
RECRUITING
Takapuna
Pacific Clinical Research Network (PCRN) Wellington
RECRUITING
Upper Hutt
Contact Information
Primary
Lisa Li
Lisa.Li@bambusatx.com
+1 858 353 4948
Time Frame
Start Date:2025-02-27
Estimated Completion Date:2027-02-06
Participants
Target number of participants:198
Treatments
Experimental: Part A Single Ascending Dose BBT001 IV
A single dose of BBT001 will be administered in healthy volunteers
Experimental: Part B Multiple Ascending Dose BBT001 IV
Three doses of BBT001 will be administered in healthy volunteers.
Experimental: Part C Multiple Ascending Dose BBT001 IV
Three doses of BBT001 will be administered in patients with atopic dermatitis.
Placebo_comparator: Part A Single Ascending Dose Placebo IV
A single dose of Placebo will be administered in healthy volunteers
Placebo_comparator: Part B Multiple Ascending Dose Placebo IV
Three doses of Placebo will be administered in healthy volunteers.
Placebo_comparator: Part C Multiple Ascending Dose Placebo IV
Three doses of Placebo will be administered in patients with atopic dermatitis.
Active_comparator: Part D Single Ascending Dose BBT001 SC
A single dose of BBT001 will be administered in healthy volunteers
Placebo_comparator: Part D Single Ascending Dose Placebo SC
A single dose of placebo will be administered in healthy volunteers
Active_comparator: Part E Multiple Ascending Dose BBT001 SC - Dose Level 1
Four doses of BBT001 will be administered in patients with atopic dermatitis.
Placebo_comparator: Part E Multiple Ascending Dose Placebo SC
Four doses of placebo will be administered in patients with atopic dermatitis.
Active_comparator: Part E Multiple Ascending Dose BBT001 SC - Dose Level 2
Four doses of BBT001 will be administered in patients with atopic dermatitis.