Health TrialsbyHealthPanel

A Study of DC6001 Tablet in Healthy Chinese Adult Subjects

ConditionStargardt Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorHeronova Pharmaceuticals

About this trial

This study adopts a randomized, double-blind, parallel placebo-controlled dose-escalation design, consisting of two parts: Part 1 includes a single ascending dose (SAD) study plus a food effect (FE) study, and Part 2 is a multiple ascending dose (MAD) study.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy volunteers aged 18-55 years (inclusive) at the time of signing the informed consent form, regardless of gender;

Male subjects with a body weight ≥ 50.0 kg and female subjects with a body weight ≥ 45.0 kg; BMI ranging from 19.0 to 28.0 kg/m² (inclusive of critical values);

Women of childbearing potential (WOCBP) or male subjects must agree to have no childbearing plans and voluntarily adopt effective contraceptive measures for 6 months from pre-screening to the last administration of the study drug, with no plans for sperm or egg donation. For WOCBP: The serum pregnancy test result of WOCBP must be negative before the first administration;

No history of major diseases; physical examination, vital signs, 12-lead electrocardiogram (ECG), chest X-ray, and laboratory test results during screening are normal, or slightly exceed the normal reference range but are deemed clinically insignificant by the investigator;

Disqualifiers

Subjects with clinically significant abnormalities or diseases occurring within 1 week prior to screening or currently present that require exclusion;

Subjects with digestive system diseases affecting the absorption of fat-soluble vitamins occurring within 3 months prior to screening or currently present;

Subjects with diseases related to vitamin A deficiency occurring within 3 months prior to screening or currently present;

Subjects with acute diseases occurring from the screening phase to the first administration of the study drug that, in the investigator's judgment, may affect the study results;

Trial design

Design model

Parallel

Treatments tested in this trial

  • DC6001

    Drug

    DC6001 tablet

  • Placebo

    Drug

    DC6001 placebo tablet

Treatment groups

76 Participants
are divided into 5 treatment groups
Group A: SAD: DC6001Experimental treatment 1 intervention
Group B: SAD: PlaceboPlacebo comparator 1 intervention
Group C: MAD: DC6001Experimental treatment 1 intervention
Group D: MAD: PlaceboPlacebo comparator 1 intervention
Group E: FE: DC6001Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants With Adverse Events

Incidence and severity of adverse events as assessed by CTCAE Version 6.0

Time frame
Up to 28 days

Secondary outcomes

1

The maximum plasma concentration of the drug (Cmax)

Time frame
From time zero up to 192 hours post-dose
2

The time at which the peak plasma concentration is reached (Tmax)

Time frame
From time zero up to 192 hours post-dose
3

The area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t)

Time frame
From time zero up to 192 hours post-dose
4

The area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)

Time frame
Time Frame: From time zero up to 192 hours post-dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Heronova Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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