Health TrialsbyHealthPanel

Phase 1a/1b Study of TRB-061 in Healthy Participants & Patients With Atopic Dermatitis

ConditionModerate-to-severe Atopic Dermatitis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTRex Bio, Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • TRB-061

    Drug

    Single subcutaneous injection of TRB-061 at escalating doses

  • TRB-061

    Drug

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

  • TRB-061

    Drug

    Subcutaneous TRB-061 administered every 4 weeks for 3 doses

  • Placebo

    Drug

    Single and multiple subcutaneous doses of placebo matching TRB-061 in patients

Treatment groups

115 Participants
are divided into 4 treatment groups
Group A: SAD - TRB-061Experimental treatment 1 intervention
Group B: MAD - TRB-061Experimental treatment 1 intervention
Group C: Phase 1b - TRB-061Experimental treatment 1 intervention
Group D: Placebo ComparatorPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

Pharmacokinetic (Maximum Observed Plasma Concentration, Cmax)

Time frame
Up to Day 85 (SAD), Up to Day 127 (MAD); up to Week 37 (Phase 1b)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

TRex Bio, Inc.

Lead sponsor

Source ClinicalTrials.gov
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