AzTrials
AzTrials

Chronic Spontaneous UrticariaPhase 1/2NCT07717905

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)

A Phase 1/2 study testing BBT001 in people with Chronic Spontaneous Urticaria, run by Bambusa Therapeutics at 10 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Spontaneous Urticaria
What is being tested?
BBT001
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
10 sitesChina
Study dates
29 Jun 2026to 30 Jun 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Inclusion Criteria: key inclusion criteria: 1)Male or female 18 to 75 years (inclusive) of age at time of consent. 2)Capped weight to be no more than 125 kg at screening.3)UAS7>=16; 4)Patients must have been on daily stable doses of H1-AH;5) Written informed consent obtained from the participant prior to performing any protocol-related procedures. For A2/A4 only: Participants who have received prior treatment with any biological products (e.g., omalizumab or dupilumab) . The last dose≥ 5 half-lives prior to randomization.

Exclusion Criteria: key exclusion criteria: 1）Inducible urticaria ; 2） Diseases with possible symptoms of urticaria or angioedema such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis ；3） Presence of skin morbidities other than CSU that may interfere with the assessment of the study outcomes; 4)History of herpes simplex infection; 5 ）Serological abnormalities of infection at screening .

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Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Tracy Ji, Study Director contact

+86 18001322760

tracy.ji@bambusatx.com

10 sites in 1 country

China10 sites, 10 recruiting

  • Peking University People's Hospital, Beijing

    Beijing, Beijing Municipality, 100032

    Jianzhong Zhang, 010-88324516, rmzjz@126.com

    cheng Zhou

    Recruiting

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510260

    Wenlin Yang, 020-34153066, gyeyyx@163.com

    Wenlin Yang

    Not yet recruiting

  • Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong, 510440

    Bin Yang, 020-8306 8888, yangbin101@hotmail.com

    Bin Yang

    Not yet recruiting

  • Hangzhou Third People's Hospital

    Hangzhou, Zhejiang, 310009

    Xingang WU, 0571-87823189, hz3ygcp@163.com

    Xingang WU

    Not yet recruiting

  • Jingzhou Central Hospital

    Jinzhou, Hubei, 434020

    Yi Sun, 0716-8881888, hbjzyyywlc@163.com

    YI Sun

    Not yet recruiting

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Guoqiang Zhang, 0311-87156653, hbydyygcp@163.com

    Guoqiang Zhang

    Not yet recruiting

  • The Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030000

    Wenli Feng, 0351-4960130, 625544524@qq.com

    Wenli Feng

    Not yet recruiting

  • The Second Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui, 241001

    Fei Wang, 0553-2871846, zhangruzhi628@163.com

    Fei Wang

    Not yet recruiting

  • Wuxi Second People's Hospital,

    Wuxi, Jiangsu, 214002

    Xunyi Dai, 0510-9612369, wx2hh@126.com

    Xunyi Dai

    Not yet recruiting

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710114

    Songmei Geng, 029-87679000, gcp@xah2h.com

    Songmei Geng

    Not yet recruiting

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Placebo-controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT001 Following Intravenous Administration in Adult Patients With Chronic Spontaneous Urticaria.

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

Read the detailed description

The study consists of below cohorts:

Cohort A1 (biologic-naïve): 450 mg BBT001 (n = 8) or placebo (n = 4) Cohort A2 (biologic-experienced): 450 mg BBT001 (n = 8) or placebo (n = 4) Cohort A3 (biologic-naïve) (optional): 900 mg BBT001 (n = 8) or placebo (n = 4) Cohort A4 (biologic-experienced) (optional): 900 mg BBT001 (n = 8) or placebo (n = 4)

Being tested
BBT001, Placebo
Medical subject headings
Chronic Urticaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BBT001Drug

    BBT001 will be administered

  • PlaceboDrug

    Placebo will be administered

Study groups in NCT07717905
Study groupRoleWhat they receive
Cohort A1:BBT001 (450mg biologic naive)Active comparatorA multiple ascending dose (MAD) of 450 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU) who are naïve to biologic therapy.
Receives: Drug: BBT001
Cohort A1:Placebo (450mg biologic naive)Placebo comparatorA multiple ascending dose (MAD) of 450 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU)who are naïve to biologic therapy.
Receives: Drug: Placebo
Cohort A2:BBT001 (450mg biologic experienced)Active comparatorA multiple ascending dose (MAD) of 450 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU) who are experienced to biologic therapy.
Receives: Drug: BBT001
Cohort A1:placebo (450mg biologic experienced)Placebo comparatorA multiple ascending dose (MAD) of 450 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU) who are experienced to biologic therapy
Receives: Drug: Placebo
Cohort A3:BBT001 (900mg biologic naive)Active comparatorA multiple ascending dose (MAD) of 900 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU) who are naïve to biologic therapy.
Receives: Drug: BBT001
Cohort A3:Placebo (900mg biologic naive)Placebo comparatorA multiple ascending dose (MAD) of 900 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU) who are naïve to biologic therapy.
Receives: Drug: Placebo
Cohort A4:BBT001 (900mg biologic experienced)Active comparatorA multiple ascending dose (MAD) of 900 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU) who are experienced to biologic therapy.
Receives: Drug: BBT001
Cohort A4:Placobo (900mg biologic experienced)Placebo comparatorA multiple ascending dose (MAD) of 900 mg BBT001 will be administered to patients with chronic spontaneous urticaria (CSU) who are experienced to biologic therapy.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: - 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.

    Measured: 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

    Measured: 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

    Measured: Up to Day 183 post first dose administration

  5. Number of participants with change in 12-lead electrocardiogram (ECG) results measurements following treatment administration.

    12-lead ECG will be tested at individual sites using sites' equipment and will be assessed.

    Measured: Up to Day 183 post first dose administration

Secondary outcomes (7)

  1. Pharmacokinetics parameters- Time for maximum observed Concentration (Tmax)

    Serum PK Tmax will be analyzed for all subjects

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: specified timepoints pre-dose and up to 183 days post first dose administration

  5. Pharmacokinetics parameters- Total clearance (CL)

    Total clearance of the study drug in serum will be analyzed for all subjects

    Measured: At specified timepoints pre-dose and up to 183 days post first dose administration

  6. Pharmacokinetics parameters- - Elimination Half-life (t1/2).

    Elimination half-life of the study drug in serum will be analyzed for all subjects

    Measured: At specified timepoints pre-dose and up to 183 days post first dose administration

  7. The immunogenicity of BBT001 is measured as the number and percentage of subjects who develop Anti-Drug Antibodies (ADA).

    Serum Anti-Drug Antibodies will be analyzed for all subjects

    Measured: At specified timepoints pre-dose and up to 183 days post first dose administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2026
  2. Study start29 Jun 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07717905
Sponsor's protocol ID
BBT001-004
Status last verified
Jul 2026
First submitted
16 Jul 2026
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BBT001 in people with Chronic Spontaneous Urticaria, run by Bambusa Therapeutics at 10 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tracy Ji, Study Director (+86 18001322760, tracy.ji@bambusatx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events following multiple administration of BBT001 (time frame: - Up to Day 183 post first dose administration). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07717905.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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