Moderate-to-severe Atopic DermatitisPhase 1NCT06934252
Phase 1a/1b Study of TRB-061 in Healthy Participants & Patients With Atopic Dermatitis
A Phase 1 study testing TRB-061 in people with Moderate-to-severe Atopic Dermatitis, run by TRex Bio, Inc. at 19 sites in 2 countries.
Trial summary
This Phase 1a/1b randomized, double-blind, placebo-controlled study evaluates the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneously (SC) administered TRB-061 in healthy adults and patients with moderate-to-severe atopic dermatitis (AD). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate-to-severe Atopic Dermatitis
- What is being tested?
- TRB-061
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 2 May 2025to 29 Feb 2028
- Phase
- Phase 1
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female participants aged 18 to 70 years, inclusive, at the time of informed consent.
- Body weight ≥50 kg and a body mass index (BMI)between 18.5 and 35.0 kg/m², inclusive.
- Participant is in good general health as determined by the investigator, based on medical history, physical examination, and clinical laboratory tests.
- For healthy participants (SAD and MAD): no clinically significant abnormalities in ECGs at screening.
- For participants in Phase 1b: Confirmed diagnosis of AD with onset of symptoms at least 1 year prior to Screening.
- Must be nonpregnant and nonlactating with negative pregnancy tests at screening and prior to dosing.
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- Must be a non-smoker or ≤5 cigarettes per week for the past 6 months (SAD/MAD only).
- For participants in Phase 1b: Moderate-to-severe AD at Screening and at Day 1 visit
- Agrees to abstain from the use of tetrahydrocannabinol (THC)-containing products while on study.
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the investigator, may put the participant at risk or interfere with study results.
- History or presence of any condition requiring systemic immunosuppressive or immunomodulatory therapy within a defined period before screening.
- Use of any biologic agent (e.g., monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) before Day 1.
- Participation in another investigational drug trial within 30 days or 5 half-lives of the prior investigational product (whichever is longer) before Day 1.
- History of hypersensitivity or allergic reaction to any component of the study drug or placebo formulation.
- Known active or latent tuberculosis (TB) infection. or history of incomplete TB treatment.
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- Positive test at screening for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) RNA, or human immunodeficiency virus (HIV).
- Active infection or history of serious infections within 4 weeks prior to Day 1.
- Clinically significant ECG abnormalities (e.g., QTcF>470 ms) or other cardiac risk factors.
- Abnormal and clinically significant laboratory values at screening.
- Use of live vaccines within 4 weeks before Day 1.
- Use of systemic corticosteroids, immunosuppressants, or immunomodulatory drugs within protocol-defined washout periods (Part 3 only).
- Recent history of alcohol or drug abuse as defined per protocol.
- Use of tobacco/nicotine products beyond protocol-allowed limits (SAD and MAD).
- Positive cotinine test at check-in (SAD/MAD only).
- Any other reason, in the opinion of the investigator or sponsor, that would make the participant unsuitable for participation in the study.
- Any medical or psychiatric condition that, in the opinion of the Investigator or Sponsor's medical monitor, would place the participant at risk, interfere with study participation, or interfere with the interpretation of study results.
- Surgery within the past 90 days prior to dosing as determined by the Investigator or Sponsor's medical monitor to be clinically relevant or planned surgery to be performed during the study and 30 days after the last dose of study drug
Trial locations and contacts
19 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
19 sites in 2 countries
New Zealand10 sites, 10 recruiting
- Recruiting
Pacific Clinical Research Network-West Auckland
Auckland, 0600
Milan Radojevic, Dr, +64 9 883 0123, MilanRadojevic@pcrn.co.nz
- Recruiting
MCR Christchurch
Christchurch, 8013
Benjamin Image, +6433371979, ben.image@momcr.co.nz
- Recruiting
Momentum Clinical Research Dunedin
Dunedin, Otago, 9016
Sarah Hortop, Dr, +64 3 974 8170, Sarah.Hortop@momentumclinicalresearch.co.nz
- Recruiting
Clinical Trials New Zealand Ltd
Hamilton, Waikato Region, 3204
Amy Stanway, Dr, +64 7 843 0105, amystanway@yahoo.co.nz
- Recruiting
Pacific Clinical Research Network-Tasman
Nelson, Tasman District, 7011
Aimee Hawker, Dr, +6432656163, aimeehawker@pcrn.co.nz
- Recruiting
Medical Research Institute of New Zealand
Newtown, Wellington Region, 6021
Karen Oldfield, Dr, +64 4 805 0235, karen.oldfield@mrinz.ac.nz
- Recruiting
MCR Palmerston North
Palmerston North, 4414
Andrew Edwards, +64 6 280 1038, andrew.edwards@momentumclinicalresearch.co.nz
- Recruiting
Momentum Clinical Research Pukekohe
Pukekohe, Auckland, 2120
Michelle Baker, Dr, +64 9 237 0121, Michelle.baker@momentumclinicalresearch.co.nz
- Recruiting
Pacific Clinical Research Network-Wellington
Upper Hutt, Wellington Region, 5018
Tim Humphrey, Dr, 021653212, Tim.Humphrey@lctwellington.co.nz
- Recruiting
Momentum Clinical Research Kapiti
Waikanae, Wellington Region, 5036
Andrew Edwards, Dr, +64 4 908 1001, andrew.edwards@momentumclinicalresearch.co.nz
Australia9 sites, 8 recruiting
- Active, not recruiting
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, 5000
- Recruiting
Paratus Clinical Brisbane Pty Ltd
Albion, Brisbane, 4010
Pi Lip Seet, Dr, 0721119168, pilip.seet@paratusclinical.com
- Recruiting
Paratus Clinical Research Western Sydney
Blacktown, New South Wales, 2148
Ushma Narsai, Dr, 1300 742 326, ushma.narsai@paratusclinical.com
- Recruiting
Cornerstone Centre for Clinical Research
Coorparoo, Queensland, 4151
Young Jin Kim, Dr, 0425 247 302, kim_youngjin@hotmail.com
- Recruiting
Paratus Clinical Research - Canberra Trial Clinic
Deakin, Australian Capital Territory, 2600
Amber Leah, Dr, 1300 742 326, amber.leah@paratusclinical.com
- Recruiting
Paratus Clinical Research Central Coast
Kanwal, New South Wales, 2259
Amber Leah, Dr, 1300 742 326, amber.leah@paratusclinical.com
- Recruiting
Paratus Clinical Research Melbourne
Melbourne, Victoria, 3070
Kianoosh Noori Samie, Dr, 1300 742 326, kianoosh.noorisamie@paratusclinical.com
- Recruiting
Alfred Health
Melbourne, 3004
Johannes Kerns, +613 9076 8592, J.Kern@alfred.org.au
- Recruiting
MCR Sunshine
Saint Albans, 3021
King Cheung, +613 9125 0799, King.Cheung@momentumclinicalresearch.com.au
About this study
Official title: A Phase 1a/1b Randomized, Double-Blind, Placebo-Controlled, 3-Part Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Subcutaneous Doses of TRB-061 in Healthy Participants and in Patients With Moderate-to-Severe Atopic Dermatitis
This Phase 1a/1b randomized, double-blind, placebo-controlled study evaluates the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneously (SC) administered TRB-061 in healthy adults and patients with moderate-to-severe atopic dermatitis (AD). The number of dosing cohorts may be increased or decreased in Part 1 (SAD) or Part 2 (MAD).
Part 1 (SAD): Healthy participants receiving single doses of TRB-061 or placebo.
Part 2 (MAD): Healthy participants receiving multiple doses (3 doses over 8 weeks) of TRB-061 or placebo.
Part 3 (Phase 1b): Participants with moderate-to-severe AD receiving repeated doses (4 doses over 12 weeks) of TRB-061 or placebo.
Read the detailed description
Healthy adults will receive a single-ascending dose (SAD) of placebo or TRB-061 in cohorts of 8 (6 active, 2 placebo). Safety data will be reviewed before dosing the remaining participants. Follow-up lasts 12 weeks post-dosing. Treatment in the multiple-ascending dose (MAD) phase will be initiated after SAD cohort safety review is completed. Healthy adults will receive 3 doses of TRB-061 or placebo every 4 weeks (Q4W) over 8 weeks. Follow-up lasts 10 weeks post-last dose.
Participants with moderate-to-severe AD (Phase 1b) will be randomized to receive one of two dose levels of TRB-061 or placebo for 12 weeks (Q4W) in Period 1. In Period 2, participants will have the option to consent to a cross over treatment where those who previously received placebo will receive TRB-061 and those who received TRB-061 will receive placebo Q4W for 12 weeks followed by a Follow Up period through End of Study (EOS). Participants who do not consent to receive crossover treatment will continue study visits including efficacy and safety assessments through the EOS visit.
- Conditions
- Moderate-to-severe Atopic Dermatitis
- Being tested
- TRB-061, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRB-061Drug
Single subcutaneous injection of TRB-061 at escalating doses
TRB-061Drug
Subcutaneous TRB-061 administered every 4 weeks for a total of 4 doses
TRB-061Drug
Subcutaneous TRB-061 administered every 4 weeks for 3 doses
PlaceboDrug
Single and multiple subcutaneous doses of placebo matching TRB-061 in patients
| Study group | Role | What they receive |
|---|---|---|
| SAD - TRB-061 | Experimental | Single ascending subcutaneous doses of TRB-061 in healthy participants Receives: Drug: TRB-061 |
| MAD - TRB-061 | Experimental | Multiple subcutaneous doses (Q4W for 8 weeks) in healthy participants Receives: Drug: TRB-061 |
| Phase 1b - TRB-061 | Experimental | Multiple subcutaneous doses (Q4W for 12 weeks) in patients with moderate-to-severe AD Receives: Drug: TRB-061 |
| Placebo Comparator | Placebo comparator | Subcutaneous placebo (matching TRB-061 in each study part) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: From Screening to Day 85 (SAD), Up to Day 127 (MAD); up to Day 253 (Phase 1b)
Secondary outcomes (1)
Pharmacokinetic (Maximum Observed Plasma Concentration, Cmax)
Measured: Up to Day 85 (SAD), Up to Day 127 (MAD); up to Week 37 (Phase 1b)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start2 May 2025
- Primary completion2 Sep 2027 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate-to-severe Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TRex Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934252
- Sponsor's protocol ID
- TRB061-AD-101
- Status last verified
- Oct 2026
- First submitted
- 11 Apr 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b Randomized, Double-Blind, Placebo-Controlled, 3-Part Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Subcutaneous Doses of TRB-061 in Healthy Participants and in Patients With Moderate-to-Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06934252
- Acronym / sponsor ID
- TRB061-AD-101
- Conditions
- Moderate-to-severe Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- TRex Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 May 2025 (actual)
- Primary completion
- 2 Sep 2027 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 1a/1b randomized, double-blind, placebo-controlled study evaluates the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneously (SC) administered TRB-061 in healthy adults and patients with moderate-to-severe atopic dermatitis (AD). The number of dosing cohorts may be increased or decreased in Part 1 (SAD) or Part 2 (MAD).
Part 1 (SAD): Healthy participants receiving single doses of TRB-061 or placebo.
Part 2 (MAD): Healthy participants receiving multiple doses (3 doses over 8 weeks) of TRB-061 or placebo.
Part 3 (Phase 1b): Participants with moderate-to-severe AD receiving repeated doses (4 doses over 12 weeks) of TRB-061 or placebo.
Detailed description
Healthy adults will receive a single-ascending dose (SAD) of placebo or TRB-061 in cohorts of 8 (6 active, 2 placebo). Safety data will be reviewed before dosing the remaining participants. Follow-up lasts 12 weeks post-dosing. Treatment in the multiple-ascending dose (MAD) phase will be initiated after SAD cohort safety review is completed. Healthy adults will receive 3 doses of TRB-061 or placebo every 4 weeks (Q4W) over 8 weeks. Follow-up lasts 10 weeks post-last dose.
Participants with moderate-to-severe AD (Phase 1b) will be randomized to receive one of two dose levels of TRB-061 or placebo for 12 weeks (Q4W) in Period 1. In Period 2, participants will have the option to consent to a cross over treatment where those who previously received placebo will receive TRB-061 and those who received TRB-061 will receive placebo Q4W for 12 weeks followed by a Follow Up period through End of Study (EOS). Participants who do not consent to receive crossover treatment will continue study visits including efficacy and safety assessments through the EOS visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SAD - TRB-061 | Experimental | Drug: TRB-061Single ascending subcutaneous doses of TRB-061 in healthy participants |
| MAD - TRB-061 | Experimental | Drug: TRB-061Multiple subcutaneous doses (Q4W for 8 weeks) in healthy participants |
| Phase 1b - TRB-061 | Experimental | Drug: TRB-061Multiple subcutaneous doses (Q4W for 12 weeks) in patients with moderate-to-severe AD |
| Placebo Comparator | Placebo comparator | Drug: PlaceboSubcutaneous placebo (matching TRB-061 in each study part) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female participants aged 18 to 70 years, inclusive, at the time of informed consent.
- Body weight ≥50 kg and a body mass index (BMI)between 18.5 and 35.0 kg/m², inclusive.
- Participant is in good general health as determined by the investigator, based on medical history, physical examination, and clinical laboratory tests.
- For healthy participants (SAD and MAD): no clinically significant abnormalities in ECGs at screening.
- For participants in Phase 1b: Confirmed diagnosis of AD with onset of symptoms at least 1 year prior to Screening.
Key exclusion criteria (18 listed)
- History of any clinically significant disease or disorder which, in the opinion of the investigator, may put the participant at risk or interfere with study results.
- History or presence of any condition requiring systemic immunosuppressive or immunomodulatory therapy within a defined period before screening.
- Use of any biologic agent (e.g., monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) before Day 1.
- Participation in another investigational drug trial within 30 days or 5 half-lives of the prior investigational product (whichever is longer) before Day 1.
- History of hypersensitivity or allergic reaction to any component of the study drug or placebo formulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRB-061Single subcutaneous injection of TRB-061 at escalating doses | Drug | SAD - TRB-061 |
| TRB-061Subcutaneous TRB-061 administered every 4 weeks for a total of 4 doses | Drug | Phase 1b - TRB-061 |
| TRB-061Subcutaneous TRB-061 administered every 4 weeks for 3 doses | Drug | MAD - TRB-061 |
| PlaceboSingle and multiple subcutaneous doses of placebo matching TRB-061 in patients | Drug | Placebo Comparator |
Primary outcome
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Screening to Day 85 (SAD), Up to Day 127 (MAD); up to Day 253 (Phase 1b)
1 secondary outcome
Pharmacokinetic (Maximum Observed Plasma Concentration, Cmax)
Time frame: Up to Day 85 (SAD), Up to Day 127 (MAD); up to Week 37 (Phase 1b)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TRB-061 in people with Moderate-to-severe Atopic Dermatitis, run by TRex Bio, Inc. at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. 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 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in New Zealand, Australia. 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 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.
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 Study Director (+1 (650) 567-5582, clinicaltrials@trex.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From Screening to Day 85 (SAD), Up to Day 127 (MAD); up to Day 253 (Phase 1b)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2026.