A Phase 1 interventional study of BBT001 and Placebo in Atopic Dermatitis, sponsored by Bambusa Therapeutics. Recruiting at 14 sites in 4 countries. Open to participants aged 18 Years to 72 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Bambusa Therapeutics · Phase 1, Interventional, and Treatment
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Among 31 studies in Dermatitis, Atopic with a site in New Zealand — 6 open to participants now, 9 under way, 1 of them phase 3. Dermatitis, Atopic · New Zealand.
Among the 31 studies in Dermatitis, Atopic with a site in New Zealand, this one is the 14th largest by planned enrollment, is one of 8 that started in 2025, is one of 9 in phase 1, and was the 24th registered.
1,592 studies on the registry are indexed under Dermatitis, Atopic; 287 are open to participants now.
Browse Dermatitis, Atopic studies →6 of the 31 studies in Dermatitis, Atopic with a site in New Zealand are open now. Recruiting first, the newest first:
Prana Therapies Inc · Sites in New Zealand, Australia
Ages 18–70
Zai Lab (Shanghai) Co., Ltd. · Sites in New Zealand, Australia, China
Ages 18–65 · Healthy volunteers
Inmagene LLC · Sites in New Zealand, United States, Australia and 1 more country
Ages 18–74
TRex Bio, Inc. · Sites in New Zealand, Australia
Ages 18–70 · Healthy volunteers
Ribon Therapeutics, Inc. · Sites in New Zealand, Australia
Ages 18–65 · Healthy volunteers
A study can be open while its sites in New Zealand have not opened yet or have stopped. Only those recruiting at a site in New Zealand →
Of the 195 Dermatitis, Atopic studies recruiting now, 83 (43%) set no upper age limit and 96 (49%) stop at 75 or younger; 94 take children under 18; 52 take healthy volunteers.
This study: 18 Years to 72 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
31 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 8 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 237 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Median enrollment 203 across the 31 interventional studies. Of the 22 that completed or were terminated, 11 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
29 of 31 have an industry lead sponsor. The 10 most frequent:
Bambusa Therapeutics is the lead sponsor of 6 studies on the registry; 6 are open to participants now.
Bambusa Therapeutics has 2 studies filed under Dermatitis, Atopic — fewer than ten, so there is no comparison to draw.
3 of the studies in Dermatitis, Atopic with a site in New Zealand that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06808477Bambusa TherapeuticsA Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Atopic Dermatitis (AD) | 2027-02-28 |
| NCT06934252TRex Bio, Inc.Phase 1a/1b Study of TRB-061 in Healthy Participants & Patients With Atopic Dermatitis | 2027-09-02 |
| NCT07810777Prana Therapies IncPRA-216 Atopic Dermatitis Safety and Efficacy Study | 2027-09-30 |
Add all 3 to your calendar (.ics) → With an account.
Among the 31 studies in Dermatitis, Atopic with a site in New Zealand, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
This study a is a randomized, double-blinded, placebo-controlled single (SAD) and multiple-ascending dose (MAD) study to evaluate safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and exploratory clinical activity of BBT001 in healthy volunteers (HVs) and in adult patients with atopic dermatitis. BBT001 is a drug candidate being developed for the treatment of atopic dermatitis.
Key Inclusion Criteria
Key Inclusion Criteria (Parts A, B, and D)
Key Inclusion Criteria (Parts C and E only)
Key Exclusion Criteria
Key Exclusion Criteria (Parts A, B, and D only)
1. History of atopic dermatitis
Key Exclusion Criteria (Parts C and E only)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A single dose of BBT001 will be administered in healthy volunteers
Drug: BBT001
Multiple doses of BBT001 will be administered in healthy volunteers.
Drug: BBT001
Multiple doses of BBT001 will be administered in patients with atopic dermatitis.
Drug: BBT001
A single dose of Placebo will be administered in healthy volunteers
Drug: Placebo
Multiple doses of Placebo will be administered in healthy volunteers.
Drug: Placebo
Multiple doses of Placebo will be administered in patients with atopic dermatitis.
Drug: Placebo
A single dose of BBT001 will be administered in healthy volunteers
Drug: BBT001
A single dose of placebo will be administered in healthy volunteers
Drug: Placebo
Multiple doses of BBT001 will be administered in patients with atopic dermatitis.
Drug: BBT001
Multiple doses of placebo will be administered in patients with atopic dermatitis.
Drug: Placebo
Multiple doses of BBT001 will be administered in patients with atopic dermatitis
Drug: BBT001
BBT001 will be administered
Placebo will be administered
Number of participants with adverse events following single and multiple administration of BBT001
Incidence, relatedness, and severity of adverse events graded per NCI CTCAE v5.0.
Time frame: Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration
Number of participants with change in serum blood parameters
Laboratory assessments include hematology, blood chemistry and coagulation test
Time frame: Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration
Number of participants with change in vital sign measurements following treatment administration.
Blood pressure and heart rate will be assessed.
Time frame: Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration
Number of participants with change in physical examination following treatment administration.
Physical examination will be assessed.
Time frame: Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration
Number of participants with change in 12-lead ECG readings
12-lead ECG will be assessed.
Time frame: Parts A and D - Up to Day 141; Parts B, C, and E - Up to Day 169 post first dose administration
Pharmacokinetics parameters - maximum observed Concentration (Cmax)
Maximum observed concentration of the study drug in serum will be analyzed for all subjects
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
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 169 days post first dose administration
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 169 days post first dose administration
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 169 days post first dose administration
Pharmacokinetics parameters - Total clearance (CL)
Total clearance of the study drug in serum will be analyzed for all subjects
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
Pharmacokinetics parameters - Elimination Half-life (t1/2).
Elimination half-life of the study drug in serum will be analyzed for all subjects
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
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
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
Not enrolling at this site.
Not enrolling at this site.
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2025 (actual). Primary completion is estimated for Feb 2027, 24 months after the start.
Of 114 industry-sponsored phase 1 interventional studies under Dermatitis, Atopic, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 20. This study's planned 24 months is above that.
Counting every sponsor, half of 131 studies reached it within 13 months; a quarter within 5 and three quarters within 20.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: BBT001
Bambusa Therapeutics