Healthy Volunteer Study
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
1 other identifier
interventional
36
1 country
1
Brief Summary
Double Blinded Healthy Volunteer study evaluating D-2570 against placebo in various doses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2025
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2025
CompletedStudy Start
First participant enrolled
December 4, 2025
CompletedFirst Posted
Study publicly available on registry
December 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
May 5, 2026
December 1, 2025
6 months
November 12, 2025
May 2, 2026
Conditions
Outcome Measures
Primary Outcomes (9)
Incidence of adverse events
Incidence of adverse events
From Informed Consent through study completion, an average of 48 days
Result of Pharmacokinetic endpoint
Tmax
From Randomization through study completion, an average of 20 days
Result of Pharmacokinetic endpoint
Cmax
From Randomization through study completion, an average of 20 days
Result of Pharmacokinetic endpoint
t1/2
From Randomization through study completion, an average of 20 days
Result of Pharmacokinetic endpoint
MRT
From Randomization through study completion, an average of 20 days
Result of Pharmacokinetic endpoint
AUC0-∞
From Randomization through study completion, an average of 20 days.
Result of Pharmacokinetic endpoint
AUC0-t
From Randomization through study completion, an average of 20 days
Result of Pharmacokinetic endpoint
CL/F
From Randomization through study completion, an average of 20 days
Result of Pharmacokinetic endpoint
Vz/F
From Randomization through study completion, an average of 20 days
Study Arms (3)
Cohort 1 D-2570/Placebo
EXPERIMENTALCohort 2 D-2570/Placebo
EXPERIMENTALCohort 3 D-2570/Placebo
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Healthy volunteer subjects meeting eligibility criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pharmaron
Baltimore, Maryland, 21201, United States
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2025
First Posted
December 8, 2025
Study Start
December 4, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
May 5, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share