Healthy Volunteer Study

July 13, 2026 updated by: InventisBio Co., Ltd

A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of D-2570 Tablets in Healthy Subjects

Double Blinded Healthy Volunteer study evaluating D-2570 against placebo in various doses.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Double blind study evaluating the safety, tolerability and PK data of D-2570/placebo in healthy volunteers.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Pharmaron

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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
  • Subjects taking medications, over the counter or herbal remedies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1 D-2570/Placebo
Drug: Placebo
Placebo
Drug: D-2570
D-2570
Experimental: Cohort 2 D-2570/Placebo
Drug: Placebo
Placebo
Drug: D-2570
D-2570
Experimental: Cohort 3 D-2570/Placebo
Drug: Placebo
Placebo
Drug: D-2570
D-2570

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: From Informed Consent through study completion, an average of 48 days
Incidence of adverse events
From Informed Consent through study completion, an average of 48 days
Result of Pharmacokinetic endpoint
Time Frame: From Randomization through study completion, an average of 20 days
Tmax
From Randomization through study completion, an average of 20 days
Result of Pharmacokinetic endpoint
Time Frame: From Randomization through study completion, an average of 20 days
Cmax
From Randomization through study completion, an average of 20 days
Result of Pharmacokinetic endpoint
Time Frame: From Randomization through study completion, an average of 20 days
t1/2
From Randomization through study completion, an average of 20 days
Result of Pharmacokinetic endpoint
Time Frame: From Randomization through study completion, an average of 20 days
MRT
From Randomization through study completion, an average of 20 days
Result of Pharmacokinetic endpoint
Time Frame: From Randomization through study completion, an average of 20 days.
AUC0-∞
From Randomization through study completion, an average of 20 days.
Result of Pharmacokinetic endpoint
Time Frame: From Randomization through study completion, an average of 20 days
AUC0-t
From Randomization through study completion, an average of 20 days
Result of Pharmacokinetic endpoint
Time Frame: From Randomization through study completion, an average of 20 days
CL/F
From Randomization through study completion, an average of 20 days
Result of Pharmacokinetic endpoint
Time Frame: From Randomization through study completion, an average of 20 days
Vz/F
From Randomization through study completion, an average of 20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InventisBio Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2025

Primary Completion (Actual)

June 25, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

November 12, 2025

First Submitted That Met QC Criteria

November 26, 2025

First Posted (Actual)

December 8, 2025

Study Record Updates

Last Update Posted (Actual)

July 14, 2026

Last Update Submitted That Met QC Criteria

July 13, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • D2570-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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