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

Part of paid clinical trials in Irvine, California.

Sponsor
Bambusa Therapeutics
Study ID
NCT06808477
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 72 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

First listed
Feb 5, 2025
Start date
Feb 27, 2025
Status verified
Jul 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

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

Arms

  • Experimental: Part A Single Ascending Dose BBT001
    A single dose of BBT001 will be administered in healthy volunteers
  • Experimental: Part B Multiple Ascending Dose BBT001
    Multiple doses of BBT001 will be administered in healthy volunteers.
  • Experimental: Part C Multiple Ascending Dose BBT001
    Multiple doses of BBT001 will be administered in patients with atopic dermatitis.
  • Placebo Comparator: Part A Single Ascending Dose Placebo
    A single dose of Placebo will be administered in healthy volunteers
  • Placebo Comparator: Part B Multiple Ascending Dose Placebo
    Multiple doses of Placebo will be administered in healthy volunteers.
  • Placebo Comparator: Part C Multiple Ascending Dose Placebo
    Multiple doses of Placebo will be administered in patients with atopic dermatitis.
  • Active Comparator: Part D Single Ascending Dose BBT001
    A single dose of BBT001 will be administered in healthy volunteers
  • Placebo Comparator: Part D Single Ascending Dose Placebo
    A single dose of placebo will be administered in healthy volunteers
  • Active Comparator: Part E Multiple Ascending Dose BBT001 - Dose Level 1
    Multiple doses of BBT001 will be administered in patients with atopic dermatitis.
  • Placebo Comparator: Part E Multiple Ascending Dose Placebo
    Multiple doses of placebo will be administered in patients with atopic dermatitis.
  • Active Comparator: Part E Multiple Ascending Dose BBT001 - Dose Level 2
    Multiple 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: Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
First OC DermatologyIrvineCalifornia92614-
OptiSkin MedicalNew YorkNew York10128-
Equity Medical, LLCThe BronxNew York10455-

Find similar trials in Irvine, CA

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
First OC Dermatology· Irvine, CAOptiSkin Medical· New York, NYEquity Medical, LLC· The Bronx, NY

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