NCT06808477

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

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 AD Patients

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: Bambusa Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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).

Detailed description

The study consists of five parts: * Part A (single dose of IV administration in HVs in sequential ascending dose cohorts, SAD IV in HVs part) * Part B (3 repeat doses of IV administration in HVs in sequential ascending dose cohorts, multiple ascending dose (MAD) IV in HVs part) * Part C (3 repeat doses in participants with moderate to severe AD, MAD IV in patients part) * Part D (single dose of SC administration in HVs in sequential ascending dose cohorts, SAD SC in HVs part) * Part E (4 repeat doses in participants with moderate to severe AD, MAD SC in patients part)

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	BBT001	BBT001 will be administered
DRUG	Placebo	Placebo will be administered

Timeline

• Start date: 2025-02-27
• Primary completion: 2026-08-21
• Completion: 2027-02-06
• First posted: 2025-02-05
• Last updated: 2025-11-17

Locations

7 sites across 3 countries: United States, Australia, New Zealand

Regulatory

• FDA-regulated drug study