NCT07270783 - Healthy Volunteer Study | Crick | Crick

Healthy Volunteer Study

Phase 1Active Not RecruitingNCT07270783

InventisBio Co., Ltd36 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

36

Conditions

Healthy Volunteer

Interventions

D-2570

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pharmaron

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Incidence of adverse events

Incidence of adverse events

Time frame: From Informed Consent through study completion, an average of 48 days

Result of Pharmacokinetic endpoint

Tmax

Time frame: From Randomization through study completion, an average of 20 days

Result of Pharmacokinetic endpoint

Cmax

Time frame: From Randomization through study completion, an average of 20 days

Result of Pharmacokinetic endpoint

t1/2

Time frame: From Randomization through study completion, an average of 20 days

Result of Pharmacokinetic endpoint

MRT

Time frame: From Randomization through study completion, an average of 20 days

Result of Pharmacokinetic endpoint

AUC0-∞

Time frame: From Randomization through study completion, an average of 20 days.

Result of Pharmacokinetic endpoint

AUC0-t

Time frame: From Randomization through study completion, an average of 20 days

Result of Pharmacokinetic endpoint

CL/F

Time frame: From Randomization through study completion, an average of 20 days

Result of Pharmacokinetic endpoint

Vz/F

Time frame: From Randomization through study completion, an average of 20 days

Data from ClinicalTrials.gov

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