A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Moderate to Severe Atopic Dermatitis (AD)

Sponsor
Bambusa Therapeutics
Study ID
NCT07239947
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • BBT001 — DRUG
    BBT001 will be administered
  • Placebo — DRUG
    Placebo will be administered

Study Details

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).

Key Dates

First listed
Nov 20, 2025
Start date
Aug 9, 2025
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
99 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Number of participants with adverse events following single and multiple administration of BBT001 [ Time Frame: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration ]

Central Contacts

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