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RECRUITING
NCT06808477
PHASE1

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

Sponsor: Bambusa Therapeutics

View on ClinicalTrials.gov

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).

Official title: A Randomized, Blinded, Placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT001 in HVs and Adult Patients With AD

Key Details

Gender

All

Age Range

18 Years - 72 Years

Study Type

INTERVENTIONAL

Enrollment

237

Start Date

2025-02-27

Completion Date

2027-02-28

Last Updated

2026-07-09

Healthy Volunteers

Yes

Interventions

DRUG

BBT001

BBT001 will be administered

DRUG

Placebo

Placebo will be administered

Locations (14)

First OC Dermatology

Irvine, California, United States

OptiSkin Medical

New York, New York, United States

Equity Medical, LLC

The Bronx, New York, United States

Fremantle Dermatology

Fremantle, Western Australia, Australia

Linear Clinical Research

Perth, Western Australia, Australia

Optimal Clinical Trials Central Auckland

Grafton, Auckland, New Zealand

Aotearoa Clinical Trials

Otahuhu, Auckland, New Zealand

Pacific Clinical Research Network (PCRN) - Auckland

Takapuna, Auckland, New Zealand

Optimal Clinical Trials Ltd - Christchurch

Christchurch, Christchurch, New Zealand

Pacific Clinical Research Network (PCRN) Wellington

Upper Hutt, New Zealand

Wojewódzki Specjalistyczny Szpital im. Dr. Wł. Biegańskiego w Łodzi

Lodz, Poland

Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie

Rzeszów, Poland

Państwowy Instytut Medyczny MSWiA

Warsaw, Poland

Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska

Wroclaw, Poland