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

Part of paid clinical trials in The Bronx, New York.

Sponsor
Bambusa Therapeutics
Study ID
NCT06808477
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) and multiple ascending dose (MAD) study of BBT001 in healthy volunteers (HVs) and adult patients with moderate to severe Atopic Dermatitis (AD).

Key Dates

Start date
Feb 27, 2025
Status verified
Nov 2025
Primary completion
Aug 21, 2026
Completion
Feb 6, 2027

Study Design

Enrollment
198 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Equity Medical, LLCThe BronxNew York10455-

Find similar trials in The Bronx, NY

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Equity Medical, LLC· The Bronx, NY

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