A Study of BBT002 in Healthy Volunteers (HVs) and in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD) or Chronic Rhiosininusitis With Nasal Polyps (CRSwNP)

Part of paid clinical trials in Bowling Green, Kentucky.

Sponsor
Bambusa Therapeutics
Study ID
NCT06944925
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • BBT002 — DRUG
    BBT002 will be administered.
  • Placebo — DRUG
    Placebo will be administered.

Study Details

Randomized study of single and multiple doses of BBT002 in healthy volunteers and in adult patients with chronic obstructive pulmonary disease (COPD) or chronic rhinosinusitis with nasal polyps (CRSwNP).

Key Dates

Start date
May 8, 2025
Status verified
Jun 2026
Primary completion
Jan 31, 2027
Completion
Jul 31, 2027

Study Design

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

Arms

  • Experimental: Part A: BBT002
    A single dose of BBT002 will be administered in healthy volunteers
  • Experimental: Part B: BBT002
    Multiple doses of BBT002 will be administered in healthy volunteers.
  • Experimental: Part C: BBT002
    Multiple doses of BBT002 will be administered in patients with COPD
  • Placebo Comparator: Part A: Placebo
    A single dose of Placebo will be administered in healthy volunteers.
  • Placebo Comparator: Part B: Placebo
    Multiple doses of Placebo will be administered in healthy volunteers.
  • Placebo Comparator: Part C: Placebo
    Multiple doses of Placebo will be administered in patients with COPD.
  • Placebo Comparator: Part D: Placebo
    Multiple doses of Placebo will be administered in patients with CRSwNP.
  • Placebo Comparator: Part E: Placebo
    Single dose of Placebo will be administered in healthy volunteers.
  • Placebo Comparator: Part F: Placebo
    Multiple doses of Placebo will be administered in patients with COPD.
  • Placebo Comparator: Part G: Placebo
    Multiple doses of Placebo will be administered in patients with CRSwNP.
  • Experimental: Part D: BBT002
    Multiple doses of BBT002 will be administered in patients with CRSwNP.
  • Experimental: Part E: BBT002
    Single dose of BBT002 will be administered in healthy volunteers.
  • Experimental: Part F: BBT002
    Multiple doses of BBT002 will be administered in patients with COPD.
  • Experimental: Part G: BBT002
    Multiple doses of BBT002 will be administered in patients with CRSwNP.

Primary Outcome Measure

Number of participants with adverse events following single and multiple administration of BBT002 [ Time Frame: Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Equity Medical Bowling GreenBowling GreenKentucky42104
Dr. James Allred
[email protected]
844-378-9633
Dr. James Allred (PRINCIPAL_INVESTIGATOR)
Equity Medical - OwensboroOwensboroKentucky42303
Dr. David Johnsonn
[email protected]
270-426-9184
Dr. David Johnsonn (PRINCIPAL_INVESTIGATOR)
Equity Medical LLCNew YorkNew York10023
Dr. Monalyn Zousias
[email protected]
844-378-9633
Dr. Monalyn Zousias (PRINCIPAL_INVESTIGATOR)

Find similar trials in Bowling Green, KY

By condition
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By specialty
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By research site
Equity Medical Bowling Green· Bowling Green, KYEquity Medical - Owensboro· Owensboro, KYEquity Medical LLC· New York, NY

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