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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT001 Following Intravenous Administration in Participants With Chronic Spontaneous Urticaria (CSU)

ConditionChronic Spontaneous Urticaria
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBambusa Therapeutics

About this trial

This is a Phase IIa, randomized, blinded, placebo controlled,Multiple-Ascending Dose study of BBT001 in adult patients with Chronic Spontaneous Urticaria.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • BBT001

    Drug

    BBT001 will be administered

  • Placebo

    Drug

    Placebo will be administered

Treatment groups

48 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Cohort A1:BBT001 (450mg biologic naive)Active comparator 1 intervention
Group B: Cohort A1:Placebo (450mg biologic naive)Placebo comparator 1 intervention
Group C: Cohort A2:BBT001 (450mg biologic experienced)Active comparator 1 intervention
Group D: Cohort A1:placebo (450mg biologic experienced)Placebo comparator 1 intervention
Group E: Cohort A3:BBT001 (900mg biologic naive)Active comparator 1 intervention
Group F: Cohort A3:Placebo (900mg biologic naive)Placebo comparator 1 intervention
Group G: Cohort A4:BBT001 (900mg biologic experienced)Active comparator 1 intervention
Group H: Cohort A4:Placobo (900mg biologic experienced)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with adverse events following multiple administration of BBT001

Incidence, relatedness, and severity of adverse events graded per NCI CTCAE v6.0.

Time frame
- Up to Day 183 post first dose administration
2

Number of participants with change in vital sign measurements following treatment administration.

Blood pressure and heart rate will be assessed.

Time frame
Up to Day 183 post first dose administratio
3

Number of participants with change in serum blood parameters.

Laboratory assessments include hematology, blood chemistry and coagulation test

Time frame
Up to Day 183 post first dose administration
4

Number of participants with change in physical examination following treatment administration

Physical examination will be assessed

Time frame
Up to Day 183 post first dose administration

Secondary outcomes

1

Pharmacokinetics parameters- Time for maximum observed Concentration (Tmax)

Serum PK Tmax will be analyzed for all subjects

Time frame
At specified timepoints pre-dose and up to 183 days post first dose administration]
2

Pharmacokinetics parameters- Area under the curve (AUC)

Area under the curve of the study drug in serum will be analyzed for all subjects

Time frame
At specified timepoints pre-dose and up to 183 days post first dose administration
3

Pharmacokinetics parameters- Volume of distribution (Vz)

Volume of distribution of the study drug in serum will be analyzed for all subjects

Time frame
At specified timepoints pre-dose and up to 183 days post first dose administration
4

Pharmacokinetics parameters- maximum observed Concentration (Cmax)

Maximum observed concentration of the study drug in serum will be analyzed for all subjects

Time frame
specified timepoints pre-dose and up to 183 days post first dose administration

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bambusa Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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