NCT07417566

A Study of DC6001 Tablet in Healthy Chinese Adult Subjects

A Randomized, Double-Blind, Parallel Placebo-Controlled, Single and Multiple Ascending Dose Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Characteristics of Oral DC6001 Tablet in Healthy Chinese Adult Subjects

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Heronova Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Part 1: SAD and FE Studies The SAD and FE studies are conducted concurrently, with a total of 5 dose groups: 2 mg, 5 mg, 10 mg, 20 mg, and 40 mg. A total of 46 healthy adult subjects are planned for enrollment. Except for the 5 mg group, each dose group will include 8 subjects, who will be randomly assigned to receive DC6001 tablets (6 subjects) or DC6001 placebo (2 subjects). The 5 mg group will be combined with the FE study, with 14 planned subjects randomly allocated to DC6001 tablets (12 subjects) or placebo (2 subjects). In the first cycle, a single dose will be administered under fasting conditions. After blood sample collection and safety assessment on Day 9 (D9), the second cycle will be conducted on Day 10 (D10) with administration under high-fat postprandial conditions, followed by blood sample collection and discharge safety examinations. Part 2: MAD Study The MAD study is tentatively designed with 3 dose groups: 2 mg, 5 mg, and 10 mg (to be adjusted based on SAD study results). A total of 30 healthy adult subjects are planned for enrollment, with 10 subjects per dose group randomly assigned to receive DC6001 tablets (8 subjects) or DC6001 placebo (2 subjects). The tentative administration regimen is once-daily fasting administration for 14 consecutive days (to be adjusted based on SAD study results). The SAD and MAD study will proceed sequentially from the lowest dose group. After subjects in a given dose group complete discharge safety examinations, the Safety Review Committee (SRC) will assess whether the dose escalation termination criteria are met. If not, the dose will be escalated to the next group until the highest dose group is completed.

Conditions

• Stargardt Disease

Interventions

Type	Name	Description
DRUG	DC6001	DC6001 tablet
DRUG	Placebo	DC6001 placebo tablet

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2026-02-18
• Last updated: 2026-02-18

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study