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

Phase 1

Recruiting

• Conditions: Atopic Dermatitis
• Interventions: Drug: BBT001; Drug: Placebo

• Registration Number: NCT06808477
• Lead Sponsor: Bambusa Therapeutics

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).

Detailed Description

The study consists of three parts:

* Part A (single dose in HVs in sequential ascending dose cohorts, SAD in HVs part)

* Part B (three repeated doses in HVs in sequential ascending dose cohorts, MAD in HVs part)

* Part C (three repeated doses in patients with moderate to severe AD, MAD in patients part)

Study Timeline

• Study First Submitted: 2025-01-30
• Study First Submitted QC: 2025-01-30
• Status Verified: 2025-02
• Study First Posted: 2025-02-05
• Study Start: 2025-02-27
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-04
• Primary Completion: 2026-08-21
• Study Completion: 2027-02-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part B Multiple Ascending Dose BBT001	BBT001	Three doses of BBT001 will be administered in healthy volunteers.
Part C Multiple Ascending Dose Placebo	Placebo	Three doses of Placebo will be administered in patients with atopic dermatitis.
Part A Single Ascending Dose Placebo	Placebo	A single dose of Placebo will be administered in healthy volunteers
Part B Multiple Ascending Dose Placebo	Placebo	Three doses of Placebo will be administered in healthy volunteers.
Part A Single Ascending Dose BBT001	BBT001	A single dose of BBT001 will be administered in healthy volunteers
Part C Multiple Ascending Dose BBT001	BBT001	Three doses of BBT001 will be administered in patients with atopic dermatitis.

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events following single and multiple administration of BBT001	Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration	Incidence, relatedness, and severity of adverse events graded per NCI CTCAE v5.0.
Number of participants with change in serum blood parameters	Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration	Laboratory assessments include hematology, blood chemistry and coagulation test
Number of participants with change in vital sign measurements following treatment administration.	Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration	Blood pressure and heart rate will be assessed.
Number of participants with change in physical examination following treatment administration.	Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration	Physical examination will be assessed.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics parameters- Area under the curve (AUC)	At specified timepoints pre-dose and up to 169 days post first dose administration	Area under the curve of the study drug in serum will be analyzed for all subjects
Pharmacokinetics parameters- Time for maximum observed Concentration (Tmax)	At specified timepoints pre-dose and up to 169 days post first dose administration	Serum PK Tmax will be analyzed for all subjects
Pharmacokinetics parameters- Volume of distribution (Vz)	At specified timepoints pre-dose and up to 169 days post first dose administration	Volume of distribution of the study drug in serum will be analyzed for all subjects
Pharmacokinetics parameters- maximum observed Concentration (Cmax)	At specified timepoints pre-dose and up to 169 days post first dose administration	Maximum observed concentration of the study drug in serum will be analyzed for all subjects
Pharmacokinetics parameters- Total clearance (CL)	At specified timepoints pre-dose and up to 169 days post first dose administration	Total clearance of the study drug in serum will be analyzed for all subjects
The immunogenicity of BBT001 is measured as the number and percentage of subjects who develop Anti-Drug Antibodies (ADA).	At specified timepoints pre-dose and up to 169 days post first dose administration	Serum Anti-Drug Antibodies will be analyzed for all subjects
Pharmacokinetics parameters- - Elimination Half-life (t1/2).	At specified timepoints pre-dose and up to 169 days post first dose administration	Elimination half-life of the study drug in serum will be analyzed for all subjects

Trial Locations

Locations (1)

Linear Clinical Research; 🇦🇺 Perth, Western Australia, Australia