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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06934252




Registration number
NCT06934252
Ethics application status
Date submitted
11/04/2025
Date registered
18/04/2025
Date last updated
18/04/2025

Titles & IDs
Public title
Phase 1a/1b Study of TRB-061 in Healthy Participants & Atopic Dermatitis Patients
Scientific 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
Secondary ID [1] 0 0
TRB061-AD-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate-to-severe Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TRB-061
Treatment: Drugs - TRB-061
Treatment: Drugs - TRB-061
Treatment: Drugs - Placebo

Experimental: SAD - TRB-061 - Single ascending subcutaneous doses of TRB-061 in healthy participants across 6 cohorts

Experimental: MAD - TRB-061 - Multiple subcutaneous doses (Q4W for 8 weeks) in healthy participants

Experimental: MAD+ - TRB-061 - Multiple subcutaneous doses (Q4W for 12 weeks) in patients with moderate-to-severe AD

Placebo comparator: Placebo Comparator - Subcutaneous placebo (matching TRB-061 in each study part


Treatment: Drugs: TRB-061
Single subcutaneous injection of TRB-061 at escalating doses

Treatment: Drugs: TRB-061
Subcutaneous TRB-061 administered every 4 weeks for a total of 4 doses

Treatment: Drugs: TRB-061
Subcutaneous TRB-061 administered every 4 weeks for 3 doses

Treatment: Drugs: Placebo
Single and multiple Subcutaneous doses of placebo matching TRB-061 in patients.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
From Screening to Day 85 (Part 1), Up to Day 127 (Part 2); up to Week 49 (Part 3)
Secondary outcome [1] 0 0
Pharmacokinetic (Maximum Observed Plasma Concentration, Cmax)
Timepoint [1] 0 0
Up to Day 85 (Part 1), Up to Day 127 (Part 2); up to Week 49 (Part 3)

Eligibility
Key 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 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: diagnosis of moderate-to-severe atopic dermatitis for at least 12 months before 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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.
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.
19. Any other reason, in the opinion of the investigator or sponsor, that would make the participant unsuitable for participation in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
28/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
22/06/2027
Actual
Sample size
Target
115
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
TRex Bio, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Director
Address 0 0
Country 0 0
Phone 0 0
+1 (650) 567-5582
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06934252