Recent Updates
Recently added Catalysts

TRB-061

Phase 1

Moderate-to-severe Atopic Dermatitis | Small molecule | Immunology |TRex Bio, Inc.|Trials Updated: Oct 28, 2026

TRB-061 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2025

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment115

FDA Designations

No designations recorded

TRB-061 clinical trials

TRB-061 · 1 trial · 1 indication

Phase 1 1
NCT06934252Phase 1a/1b Study of TRB-061 in Healthy Participants & Patients With Atopic DermatitisModerate-to-severe Atopic Dermatitis
RECRUITING115 Analytics
PHASE1RECRUITING
Phase 1a/1b Study of TRB-061 in Healthy Participants & Patients With Atopic Dermatitis
Moderate-to-severe Atopic Dermatitis
NCT06934252115
Unlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
From Screening to Day 85 (SAD), Up to Day 127 (MAD); up to Day 253 (Phase 1b)

Secondary Endpoints

Pharmacokinetic (Maximum Observed Plasma Concentration, Cmax)
Up to Day 85 (SAD), Up to Day 127 (MAD); up to Week 37 (Phase 1b)
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SAD - TRB-061EXPERIMENTALSingle ascending subcutaneous doses of TRB-061 in healthy participants
MAD - TRB-061EXPERIMENTALMultiple subcutaneous doses (Q4W for 8 weeks) in healthy participants
Phase 1b - TRB-061EXPERIMENTALMultiple subcutaneous doses (Q4W for 12 weeks) in patients with moderate-to-severe AD
Placebo ComparatorPLACEBO_COMPARATORSubcutaneous placebo (matching TRB-061 in each study part)

Interventions

NameTypeDescription
TRB-061DRUGSingle subcutaneous injection of TRB-061 at escalating doses
PlaceboDRUGSingle and multiple subcutaneous doses of placebo matching TRB-061 in patients
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersYes
Study Sites19

Inclusion Criteria: 1. Male or female participants aged 18 to 70 years, inclusive, at the time of informed consent. 2. Body weight ≥50 kg and a body mass index (BMI)between 18.5 and 35.0 kg/m², inclusive. 3. Participant is in good general health as determined by the investigator, based on medical h...

Countries:AustraliaNew Zealand
Unlock Eligibility Criteria

Explore more on BiopharmaWatch

TRex Bio, Inc. (TRXB)Pipeline, catalysts, financials, insiders and newsModerate to Severe Atopic Dermatitis disease mapEvery company developing for Moderate to Severe Atopic Dermatitis, by stage and capitalFDA calendarUpcoming PDUFA dates, AdComs and approval oddsPDUFA calendarEvery scheduled FDA decision date, month by monthHistorical FDA calendarPast decisions and how the stock moved on eachCatalyst SyncUpcoming readouts and decisions, screened by runway and phaseBiotech stock screenerFilter by clinical phase, cash runway and market capDrugs A to ZEvery drug page starting with TCompanies A to ZEvery biotech and pharma company we track