NCT06808477

Brief 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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P75+ for phase_1

Timeline
9mo left

Started Feb 2025

Typical duration for phase_1

Geographic Reach
3 countries

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Feb 2025Feb 2027

First Submitted

Initial submission to the registry

January 30, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

February 27, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2027

Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

1.5 years

First QC Date

January 30, 2025

Last Update Submit

November 13, 2025

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (4)

  • Number of participants with adverse events following single and multiple administration of BBT001

    Incidence, relatedness, and severity of adverse events graded per NCI CTCAE v5.0.

    Part A and D - Up to Day 141; Part B, C and E - Up to Day 169 post first dose administration

  • Number of participants with change in serum blood parameters

    Laboratory assessments include hematology, blood chemistry and coagulation test

    Part A and D - Up to Day 141; Part B, C and E - Up to Day 169 post first dose administration

  • Number of participants with change in vital sign measurements following treatment administration.

    Blood pressure and heart rate will be assessed.

    Part A and D - Up to Day 141; Part B, C and E - Up to Day 169 post first dose administration

  • Number of participants with change in physical examination following treatment administration.

    Physical examination will be assessed.

    Part A and D - Up to Day 141; Part B, C and E - Up to Day 169 post first dose administration

Secondary Outcomes (7)

  • Pharmacokinetics parameters- maximum observed Concentration (Cmax)

    At specified timepoints pre-dose and up to 169 days post first dose administration

  • Pharmacokinetics parameters- Time for maximum observed Concentration (Tmax)

    At specified timepoints pre-dose and up to 169 days post first dose administration

  • Pharmacokinetics parameters- Area under the curve (AUC)

    At specified timepoints pre-dose and up to 169 days post first dose administration

  • Pharmacokinetics parameters- Volume of distribution (Vz)

    At specified timepoints pre-dose and up to 169 days post first dose administration

  • Pharmacokinetics parameters- Total clearance (CL)

    At specified timepoints pre-dose and up to 169 days post first dose administration

  • +2 more secondary outcomes

Study Arms (11)

Part A Single Ascending Dose BBT001 IV

EXPERIMENTAL

A single dose of BBT001 will be administered in healthy volunteers

Drug: BBT001

Part B Multiple Ascending Dose BBT001 IV

EXPERIMENTAL

Three doses of BBT001 will be administered in healthy volunteers.

Drug: BBT001

Part C Multiple Ascending Dose BBT001 IV

EXPERIMENTAL

Three doses of BBT001 will be administered in patients with atopic dermatitis.

Drug: BBT001

Part A Single Ascending Dose Placebo IV

PLACEBO COMPARATOR

A single dose of Placebo will be administered in healthy volunteers

Drug: Placebo

Part B Multiple Ascending Dose Placebo IV

PLACEBO COMPARATOR

Three doses of Placebo will be administered in healthy volunteers.

Drug: Placebo

Part C Multiple Ascending Dose Placebo IV

PLACEBO COMPARATOR

Three doses of Placebo will be administered in patients with atopic dermatitis.

Drug: Placebo

Part D Single Ascending Dose BBT001 SC

ACTIVE COMPARATOR

A single dose of BBT001 will be administered in healthy volunteers

Drug: BBT001

Part D Single Ascending Dose Placebo SC

PLACEBO COMPARATOR

A single dose of placebo will be administered in healthy volunteers

Drug: Placebo

Part E Multiple Ascending Dose BBT001 SC - Dose Level 1

ACTIVE COMPARATOR

Four doses of BBT001 will be administered in patients with atopic dermatitis.

Drug: BBT001

Part E Multiple Ascending Dose Placebo SC

PLACEBO COMPARATOR

Four doses of placebo will be administered in patients with atopic dermatitis.

Drug: Placebo

Part E Multiple Ascending Dose BBT001 SC - Dose Level 2

ACTIVE COMPARATOR

Four doses of BBT001 will be administered in patients with atopic dermatitis.

Drug: BBT001

Interventions

BBT001DRUG

BBT001 will be administered

Part A Single Ascending Dose BBT001 IVPart B Multiple Ascending Dose BBT001 IVPart C Multiple Ascending Dose BBT001 IVPart D Single Ascending Dose BBT001 SCPart E Multiple Ascending Dose BBT001 SC - Dose Level 1Part E Multiple Ascending Dose BBT001 SC - Dose Level 2
PlaceboDRUG

Placebo will be administered

Part A Single Ascending Dose Placebo IVPart B Multiple Ascending Dose Placebo IVPart C Multiple Ascending Dose Placebo IVPart D Single Ascending Dose Placebo SCPart E Multiple Ascending Dose Placebo SC

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Significant health issues, such as: diabetes, positive tests for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B surface antigen (HBsAg), immunodeficiencies, autoimmune diseases, or cancer, history of conditions predisposing to infections.
  • History of major metabolic, dermatological, liver, kidney, hematological, or other significant disorders.
  • Clinically relevant abnormal lab results, including low blood counts, liver issues, or abnormal kidney function.
  • Positive drug/alcohol tests or abnormal vital signs at screening or Day -1.
  • Abnormal Electrocardiogram (ECG) findings
  • History of drug/alcohol abuse in the past 2 years.
  • Donated \>500mL blood within 2 months of screening.
  • History of severe allergic reactions or hypersensitivity.
  • Skin diseases other than atopic dermatitis, significant tattoos, or scarring.
  • Receipt of immunoglobulin or blood products within 30 days.
  • Atopic dermatitis with ocular symptoms or chronic ocular steroid use.
  • Chronic pruritus from conditions other than atopic dermatitis.
  • Acute/treated infections or chronic skin infections.
  • Current use of sedating antihistamines or corticosteroids.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Equity Medical, LLC

The Bronx, New York, 10455, United States

NOT YET RECRUITING

Linear Clinical Research

Perth, Western Australia, 6009, Australia

RECRUITING

Optimal Clinical Trials Central Auckland

Grafton, Auckland, 1010, New Zealand

RECRUITING

Aotearoa Clinical Trials

Otahuhu, Auckland, 2025, New Zealand

RECRUITING

Pacific Clinical Research Network (PCRN) - Auckland

Takapuna, Auckland, 0622, New Zealand

RECRUITING

Optimal Clinical Trials Ltd - Christchurch

Christchurch Central City, Christchurch, New Zealand

NOT YET RECRUITING

Pacific Clinical Research Network (PCRN) Wellington

Upper Hutt, 5018, New Zealand

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Lisa Li

    Bambusa Therapeutics, Inc.

    STUDY DIRECTOR

Central Study Contacts

Lisa Li

CONTACT

+1 858 353 4948Lisa.Li@bambusatx.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2025

First Posted

February 5, 2025

Study Start

February 27, 2025

Primary Completion (Estimated)

August 21, 2026

Study Completion (Estimated)

February 6, 2027

Last Updated

November 17, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)AU(1)NZ(5)