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Clinical Trial NCT06934252 for Moderate-to-severe Atopic Dermatitis is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Phase 1a/1b Study of TRB-061 in Healthy Participants & Atopic Dermatitis Patients Phase 1 115 Randomized Double-Blind Placebo-Controlled Single Dose

Recruiting
Clinical Trial NCT06934252 is designed to study Treatment for Moderate-to-severe Atopic Dermatitis. It is a Phase 1 interventional study that is recruiting, having started on 2 May 2025, with plans to enroll 115 participants. Led by TRex Bio, Inc., it is expected to complete by 29 February 2028. The latest data from ClinicalTrials.gov was last updated on 2 March 2026.
Brief 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). The number of dosing cohorts may be increased or decreased in Part 1 or Part 2.

Part 1 (SAD): Healthy participants receiving single doses of TRB-061 or place...

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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...Show More
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

Conditions
Moderate-to-severe Atopic Dermatitis
Other Study IDs
  • TRB061-AD-101
NCT ID Number
NCT06934252
Start Date (Actual)
2025-05-02
Last Update Posted
2026-03-02
Completion Date (Estimated)
2028-02-29
Enrollment (Estimated)
115
Study Type
Interventional
PHASE
Phase 1
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalSAD - TRB-061
Single ascending subcutaneous doses of TRB-061 in healthy participants
TRB-061
Single subcutaneous injection of TRB-061 at escalating doses
ExperimentalMAD - TRB-061
Multiple subcutaneous doses (Q4W for 8 weeks) in healthy participants
TRB-061
Subcutaneous TRB-061 administered every 4 weeks for 3 doses
ExperimentalPart 3 Phase 1b - TRB-061
Multiple subcutaneous doses (Q4W for 12 weeks) in patients with moderate-to-severe AD
TRB-061
Subcutaneous TRB-061 administered every 4 weeks for a total of 4 doses
Placebo ComparatorPlacebo Comparator
Subcutaneous placebo (matching TRB-061 in each study part)
Placebo
Single and multiple subcutaneous doses of placebo matching TRB-061 in patients
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
From Screening to Day 85 (Part 1), Up to Day 127 (Part 2); up to Day 337 (Part 3)
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Pharmacokinetic (Maximum Observed Plasma Concentration, Cmax)
Up to Day 85 (Part 1), Up to Day 127 (Part 2); up to Week 49 (Part 3)
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes

  1. Male or female participants aged 18 to 70 years, inclusive, at the time of informed consent.

  2. Body weight ≥50 kg and 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 history, physical examination, and clinical laboratory tests.

  4. For healthy participants (Parts 1 and 2): no clinically significant abnormalities in laboratory results, ECGs, or physical exams at screening.

  5. For participants in Part 3: Confirmed diagnosis of AD with onset of symptoms at least 1 year prior to Screening.

  6. Must be nonpregnant and nonlactating with negative pregnancy tests at screening and prior to dosing.

  7. Must be a non-smoker or ≤5 cigarettes per week for the past 6 months (SAD/MAD only).

  8. Moderate-to-severe AD at Screening and at Day 1 visit as defined by:

    1. EASI score ≥16,
    2. BSA affected ≥10%,
    3. vIGA-AD score ≥3, and
    4. Pruritus NRS score ≥3.

  1. 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.
  2. History or presence of any condition requiring systemic immunosuppressive or immunomodulatory therapy within a defined period before screening.
  3. Use of any biologic agent (e.g., monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) before Day 1.
  4. Participation in another investigational drug trial within 30 days or 5 half-lives of the investigational product (whichever is longer) before Day 1.
  5. History of hypersensitivity or allergic reaction to any component of the study drug or placebo formulation.
  6. Known active or latent tuberculosis (TB) infection or history of incomplete TB treatment.
  7. Positive test at screening for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) RNA, or human immunodeficiency virus (HIV).
  8. Active infection or history of serious infections within 4 weeks prior to Day 1.
  9. History of malignancy (except treated and cured non-melanoma skin cancers or cervical carcinoma in situ).
  10. Pregnant or breastfeeding women, or women planning to become pregnant during the study or within a specified time after the last dose.
  11. Clinically significant ECG abnormalities (e.g., QTcF >470 ms) or other cardiac risk factors.
  12. Abnormal laboratory values at screening.
  13. Use of live vaccines within 4 weeks before Day 1.
  14. Use of systemic corticosteroids, immunosuppressants, or immunomodulatory drugs within protocol-defined washout periods (Part 3 Phase 1b only).
  15. Active COVID-19 infection or symptoms, or positive COVID-19 test at screening.
  16. History of alcohol or drug abuse within the past year.
  17. Use of tobacco/nicotine products beyond protocol-allowed limits.
  18. Positive cotinine test at check-in (SAD/MAD only).
  19. Any other reason, in the opinion of the investigator or sponsor, that would make the participant unsuitable for participation in the study.
  20. 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.
  21. 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.
TRex Bio, Inc. logoTRex Bio, Inc.
Study Central Contact
Contact: Study Director, +1 (650) 567-5582, [email protected]
14 Study Locations in 2 Countries

Australian Capital Territory

Paratus Clinical Research - Canberra Trial Clinic, Belconnen, Australian Capital Territory, 2617, Australia
Amber Leah, Dr, Contact, 1300 742 326, [email protected]
Not yet recruiting

Brisbane

Paratus Clinical Brisbane Pty Ltd, Albion, Brisbane, 4010, Australia
Pi Lip Seet, Dr, Contact, 0721119168, [email protected]
Not yet recruiting

New South Wales

Paratus Clinical Research Western Sydney, Blacktown, New South Wales, 2148, Australia
Dominic Douglas, Dr, Contact, 1300 742 326, [email protected]
Not yet recruiting
Paratus Clinical Research Central Coast, Kanwal, New South Wales, 2259, Australia
Ian Forsyth, Dr, Contact, 1300 742 326, [email protected]
Not yet recruiting

Queensland

Cornerstone Centre for Clinical Research, Coorparoo, Queensland, 4151, Australia
Young Jin Kim, Dr, Contact, 0425 247 302, [email protected]
Not yet recruiting

South Australia

CMAX Clinical Research Pty Ltd, Adelaide, South Australia, 5000, Australia
Emir Redzepagic, Dr, Contact, +61 08 7088 7900, [email protected]
Recruiting

Victoria

Paratus Clinical Research Melbourne, Melbourne, Victoria, 3070, Australia
Yair Edinburg, Dr, Contact, 1300 742 326, [email protected]
Not yet recruiting

Auckland

Momentum Clinical Research Pukekohe, Pukekohe, Auckland, 2120, New Zealand
Michelle Baker, Dr, Contact, +64 9 237 0121, [email protected]
Not yet recruiting

Otago

Momentum Clinical Research Dunedin, Dunedin, Otago, 9016, New Zealand
Sarah Hortop, Dr, Contact, +64 3 974 8170, [email protected]
Not yet recruiting

Tasman District

Pacific Clinical Research Network-Tasman, Nelson, Tasman District, 7011, New Zealand
Claire Thurlow, Dr, Contact, +64 21 144 8740, [email protected]
Not yet recruiting

Wellington Region

Medical Research Institute of New Zealand, Newtown, Wellington Region, 6021, New Zealand
Karen Oldfield, Dr, Contact, +64 4 805 0235, [email protected]
Not yet recruiting
Pacific Clinical Research Network-Wellington, Upper Hutt, Wellington Region, 5018, New Zealand
Tim Humphrey, Dr, Contact, 021653212, [email protected]
Not yet recruiting
Momentum Clinical Research Kapiti, Waikanae, Wellington Region, 5036, New Zealand
Andrew Edwards, Dr, Contact, +64 4 908 1001, [email protected]
Not yet recruiting
Pacific Clinical Research Network-West Auckland, Auckland, 0600, New Zealand
Milan Radojevic, Dr, Contact, +64 9 883 0123, [email protected]
Not yet recruiting