BBT001 for Atopic Dermatitis

Recruiting at 6 trial locations

Overseen By Lisa Li

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Bambusa Therapeutics

Must not be taking: Sedating antihistamines, Corticosteroids

Disqualifiers: Diabetes, HIV, Cancer, others

Compensation: Varies

Number of Visits: Unknown

198 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on a new treatment called BBT001, designed to help those with moderate to severe atopic dermatitis, a chronic skin condition that causes itchy and inflamed skin. The trial will test different doses of BBT001 in both healthy volunteers and individuals with atopic dermatitis to assess the body's response and safety. Those with atopic dermatitis for at least a year and limited success with topical treatments might be suitable candidates for this trial. Participants will receive either BBT001 or a placebo (a substance with no active medicine) to compare results. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop using sedating antihistamines or corticosteroids if you are currently taking them.

Is there any evidence suggesting that BBT001 is likely to be safe for humans?

Research has shown that BBT001 is safe for healthy volunteers. Studies found that both the IV (through a vein) and SC (under the skin) forms of BBT001 were well-tolerated. No major side effects emerged, and the treatment was considered safe for humans so far. These results come from tests with healthy individuals, and now the treatment is being tested in people with atopic dermatitis, a skin condition. The positive safety results from earlier tests suggest that BBT001 might continue to be safe as testing progresses. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about BBT001 because it offers a potentially innovative approach to treating atopic dermatitis. Unlike standard treatments, which typically involve topical corticosteroids or immunosuppressants like tacrolimus, BBT001 is administered intravenously or subcutaneously, providing a new delivery method that could enhance absorption and effectiveness. Furthermore, BBT001 may work through a novel mechanism of action not yet fully explored in existing therapies, potentially offering relief for patients who do not respond well to current options. The possibility of a rapid and effective treatment is stirring interest among experts looking for alternatives to the usual long-term topical applications.

What evidence suggests that BBT001 might be an effective treatment for atopic dermatitis?

Studies have shown that BBT001 has promising results for treating atopic dermatitis. Research indicates that a single dose of BBT001 significantly decreased TARC levels, markers linked to inflammation in atopic dermatitis. This suggests that BBT001 might help reduce symptoms by targeting inflammation. Additionally, initial findings indicate that BBT001 has a good safety profile, meaning it is generally safe for patients. These early results provide hope that BBT001 could become a leading treatment option for managing atopic dermatitis. Participants in this trial will receive BBT001 in various dosing regimens to further evaluate its effectiveness and safety. ^{2 6 7 8 9}

Who Is on the Research Team?

Lisa Li

Principal Investigator

Bambusa Therapeutics, Inc.

Are You a Good Fit for This Trial?

This trial is for healthy adults and those with moderate to severe Atopic Dermatitis (AD). Participants must have a body weight between 18-32 kg/m², not exceed 120 kg, avoid alcohol before visits, be non-smokers or light smokers, and use contraception. Women need negative pregnancy tests. Those with chronic AD can join if topical treatments failed or aren't suitable.

Inclusion Criteria

I do not smoke, smoke lightly, or have quit smoking.

I meet the main requirements for parts A, B, and C of the study.

I can avoid alcohol for 24 hours before each study visit.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD) IV Administration

Single dose of BBT001 or placebo administered intravenously to healthy volunteers in sequential ascending dose cohorts

Up to 141 days

Multiple Ascending Dose (MAD) IV Administration

Three repeat doses of BBT001 or placebo administered intravenously to healthy volunteers and patients with atopic dermatitis in sequential ascending dose cohorts

Up to 169 days

Single Ascending Dose (SAD) SC Administration

Single dose of BBT001 or placebo administered subcutaneously to healthy volunteers in sequential ascending dose cohorts

Up to 141 days

Multiple Ascending Dose (MAD) SC Administration

Four repeat doses of BBT001 or placebo administered subcutaneously to patients with atopic dermatitis in sequential ascending dose cohorts

Up to 169 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BBT001

Trial Overview The study is testing BBT001's safety and effects in two groups: one receiving the actual drug and another getting a placebo. It's done in phases where single doses are given first (SAD), followed by multiple doses over time (MAD) to both healthy volunteers and AD patients.

How Is the Trial Designed?

Group I: Part C Multiple Ascending Dose BBT001 IV Experimental Treatment 1 Intervention

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

Group II: Part B Multiple Ascending Dose BBT001 IV Experimental Treatment 1 Intervention

Three doses of BBT001 will be administered in healthy volunteers.

Group III: Part A Single Ascending Dose BBT001 IV Experimental Treatment 1 Intervention

A single dose of BBT001 will be administered in healthy volunteers

Group IV: Part D Single Ascending Dose BBT001 SC Active Control 1 Intervention

A single dose of BBT001 will be administered in healthy volunteers

Group V: Part E Multiple Ascending Dose BBT001 SC - Dose Level 1 Active Control 1 Intervention

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

Group VI: Part E Multiple Ascending Dose BBT001 SC - Dose Level 2 Active Control 1 Intervention

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

Group VII: Part A Single Ascending Dose Placebo IV Placebo Group 1 Intervention

A single dose of Placebo will be administered in healthy volunteers

Group VIII: Part B Multiple Ascending Dose Placebo IV Placebo Group 1 Intervention

Three doses of Placebo will be administered in healthy volunteers.

Group IX: Part C Multiple Ascending Dose Placebo IV Placebo Group 1 Intervention

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

Group X: Part D Single Ascending Dose Placebo SC Placebo Group 1 Intervention

A single dose of placebo will be administered in healthy volunteers

Group XI: Part E Multiple Ascending Dose Placebo SC Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Bambusa Therapeutics

Lead Sponsor

Trials

1

Recruited

100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06808477

NCT06808477 | A Study of BBT001 in Healthy Volunteers ... This is a Phase 1, randomized, blinded, placebo controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study of BBT001 in healthy volunteers ...

2. biospace.com biospace.com/press-releases/bambusa-therapeutics-announces-highly-positive-healthy-volunteer-results-and-first-atopic-dermatitis-patient-dosed-in-phase-i-trial-of-bbt001

Bambusa Therapeutics Announces Highly Positive Healthy ... "These results provide the first clinical evidence of BBT001's potential to become a best-in-disease biologic in atopic dermatitis," said Thang ...

3. thedermdigest.com thedermdigest.com/ad-pipeline-watch-bambusas-bbt001-advances-to-patient-dosing/

AD Pipeline Watch: Bambusa's BBT001 Advances to ... AD candidate BBT001 performed well in the single-ascending dose part of the ongoing Phase I healthy volunteer study.

4. prnewswire.com prnewswire.com/news-releases/bambusa-therapeutics-announces-highly-positive-healthy-volunteer-results-and-first-atopic-dermatitis-patient-dosed-in-phase-i-trial-of-bbt001-302567230.html

Bambusa Therapeutics Announces Highly Positive Healthy ... An unprecedented, dose-dependent, rapid, deep, and sustained reduction in TARC levels after a single dose of BBT001, with potent suppression ...

5. trial.medpath.com trial.medpath.com/news/75e8d9ed5cc5ab4f/bambusa-therapeutics-advances-bbt001-bispecific-antibody-to-patient-testing-following-promising-healthy-volunteer-data

Bambusa Therapeutics Advances BBT001 Bispecific Antibody ... Bambusa Therapeutics reported highly positive Phase I healthy volunteer results for BBT001, demonstrating favorable safety profile and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06808477

NCT06808477 | A Study of BBT001 in Healthy Volunteers ... This is a Phase 1, randomized, blinded, placebo controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study of BBT001 in healthy volunteers ...

7. pryzm.ozmosi.com pryzm.ozmosi.com/product/33845

BBT-001 Drug Profile Bambusa Therapeutics Announces Highly Positive Healthy Volunteer Results and First Atopic Dermatitis Patient Dosed in Phase I Trial of BBT001 ... data for a ...

8. firstwordpharma.com firstwordpharma.com/story/6109156

Bambusa Therapeutics Announces Highly Positive Healthy ... BBT001-001 is a randomized, placebo-controlled, single- and multiple-ascending-dose study in healthy volunteers and adults with moderate to ...

9. jidonline.org jidonline.org/article/S0022-202X(25)03437-2/pdf

Phase 1 S Method: BBT001-001 (NCT06808477) is an ongoing, randomized, double-blind, placebo-controlled first-in-human study assessing safety, tolerability, ...