NCT07239947

A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Moderate to Severe 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 Patient

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (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) study of BBT001 in healthy volunteers (HVs) and adult patients with moderate to severe Atopic Dermatitis (AD).

Detailed description

The study consists of two parts: Part A (single dose in HVs in sequential ascending dose cohorts, SAD in HVs part) Part B (seven repeated doses in patients with moderate to severe AD, multiple ascending Dose 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: 2025-08-09
• Primary completion: 2026-08-31
• Completion: 2027-03-26
• First posted: 2025-11-20
• Last updated: 2025-11-20

Locations

10 sites across 1 country: China

Regulatory

• FDA-regulated drug study