BridgeMD
New treatment option for Moderate-to-severe Atopic Dermatitis
Official title Phase 1a/1b Study of TRB-061 in Healthy Participants & Patients With Atopic Dermatitis
ClinicalTrials.gov ID: NCT06934252
What this study is testing
What is TRB-061?
TRB-061 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for moderate-to-severe atopic dermatitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- Time commitment: about 12 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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.
You likely can't join if
- History of any clinically significant disease or disorder which, in the opinion of the investigator, may put the participant at risk or interfere...
- 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...
- 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.
See the full eligibility criteria
- 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.
- 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.
- 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.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Belconnen, Australian Capital Territory, Australia
- Albion, Brisbane, Australia
- Blacktown, New South Wales, Australia
- Kanwal, New South Wales, Australia
- Coorparoo, Queensland, Australia
- Adelaide, South Australia, Australia
- Melbourne, Victoria, Australia
- Pukekohe, Auckland, New Zealand
- Dunedin, Otago, New Zealand
- Nelson, Tasman District, New Zealand
- Hamilton, Waikato Region, New Zealand
- Newtown, Wellington Region, New Zealand
- Upper Hutt, Wellington Region, New Zealand
- Waikanae, Wellington Region, New Zealand
- Auckland, New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Belconnen, Australian Capital Territory, Australia; Albion, Brisbane, Australia; Blacktown, New South Wales, Australia; Kanwal, New South Wales, Australia; Coorparoo, Queensland, Australia; Adelaide, South Australia, Australia and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.