D-2570 for Healthy Volunteers

Overseen By Kathryn Stazzone

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: InventisBio Co., Ltd

Must not be taking: Medications, OTC, herbal

Disqualifiers: Disease, Drug abuse, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 20 days

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called D-2570 by comparing it to a placebo at various doses. The main goal is to assess its safety and how the body processes it. The study involves different groups, each receiving either the treatment or a placebo. Individuals who are generally healthy, not taking medications, and without ongoing health issues might be suitable candidates. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop taking my current medications for the trial?

Yes, you will need to stop taking your current medications, including over-the-counter and herbal remedies, to participate in this trial.

Is there any evidence suggesting that D-2570 is likely to be safe for humans?

Research shows that D-2570 has been tested in healthy volunteers to assess its safety. Previous studies found that most participants tolerated it well, indicating a good safety record. In a study involving individuals with moderate-to-severe plaque psoriasis, D-2570 proved both effective and safe. This suggests that D-2570 is generally well-tolerated, even by those with health conditions. Since this trial involves healthy volunteers, it will likely focus on understanding how different doses are tolerated and identifying any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

D-2570 is unique because it offers a fresh approach with its novel mechanism of action, setting it apart from standard treatments. Unlike traditional therapies, which might focus on specific symptoms or pathways, D-2570 targets a different biological pathway, potentially offering more effective results. Researchers are excited about D-2570 because this new mechanism could lead to faster and more sustained benefits, making it an exciting development in the treatment landscape.

What evidence suggests that D-2570 could be effective?

Research has shown that D-2570 could effectively treat moderate-to-severe plaque psoriasis. Studies have found that D-2570 significantly improves skin clearance, effectively clearing up the skin. It is also considered safe, with only minor side effects. This suggests that D-2570 might be a good treatment option for people with skin conditions like psoriasis. However, more research is needed to determine its effectiveness for other conditions or groups. In this trial, healthy volunteers will receive either D-2570 or a placebo to further evaluate its safety and effects. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy volunteers who don't have any ongoing diseases or a history of significant health issues. Participants should not be using any medications, including over-the-counter drugs and herbal remedies, and must not have a history of drug or alcohol abuse.

Inclusion Criteria

Healthy volunteer subjects meeting eligibility criteria

Exclusion Criteria

Subjects with ongoing or history of disease or co-morbidities as assessed by Principal Investigator which would make them ineligible for the study

Subjects with a history of drug and alcohol abuse

I am currently taking prescribed, over-the-counter, or herbal medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive single and multiple ascending doses of D-2570 or placebo

20 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• D-2570

Trial Overview The study is testing D-2570 against a placebo in various doses to see its effects when taken by healthy individuals. The study design ensures neither the participants nor the researchers know who receives the actual drug or placebo (double-blinded).

How Is the Trial Designed?

Group I: Cohort 3 D-2570/Placebo Experimental Treatment 2 Interventions

Group II: Cohort 2 D-2570/Placebo Experimental Treatment 2 Interventions

Group III: Cohort 1 D-2570/Placebo Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

InventisBio Co., Ltd

Lead Sponsor

Trials

20

Recruited

1,800+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07270783

Study Details | NCT07270783 | Healthy Volunteer Study Double blind study evaluating the safety, tolerability and PK data of D-2570/placebo in healthy volunteers. Official Title. A Randomized, Double-Blind ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06278350

NCT06278350 | Evaluate the Efficacy and Safety of D-2570 ... A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40967307/

Novel TYK2 inhibitor D-2570 in moderate-to-severe plaque ... Conclusion: D-2570 demonstrated a high efficacy with favorable safety profile in patients with moderate-to-severe plaque psoriasis.

4. biospace.com biospace.com/press-releases/inventisbio-announces-positive-phase-2-study-results-for-d-2570-tyk2-inhibitor-in-patients-with-moderate-to-severe-plaque-psoriasis

InventisBio Announces Positive Phase 2 Study Results for ... The randomized, multicenter, double-blind, placebo-controlled study demonstrated that D-2570 achieved significant efficacy in improving skin clearance.

5. prnewswire.com prnewswire.com/news-releases/inventisbio-announces-positive-phase-2-study-results-for-d-2570-tyk2-inhibitor-in-patients-with-moderate-to-severe-plaque-psoriasis-302320739.html

InventisBio Announces Positive Phase 2 Study Results for ... The randomized, multicenter, double-blind, placebo-controlled study demonstrated that D-2570 achieved significant efficacy in improving skin clearance.

6. trial.medpath.com trial.medpath.com/clinical-trial/036bdccc65b2323f/nct07270783-d-2570-tablets-safety-tolerability-pk-healthy-subjects

Healthy Volunteer Study | MedPath Double blind study evaluating the safety, tolerability and PK data of D-2570/placebo in healthy volunteers. ... Healthy volunteer subjects meeting ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07130604

NCT07130604 | Evaluate the Efficacy and Safety of D-2570 ... A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to ...