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Safety, Tolerability and Pharmacokinetic Characteristics Evaluation on DA414

NCT06525168 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2024-07-29

No results posted yet for this study

Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and Food Effects of DA414 Granules in Chinese healthy subjects with single and multiple doses.

Conditions

Interventions

DRUG

DA414 Granules

DA414 Granules single ascending doses. DA414 will be orally administrated at single ascending doses of 12.5 mg, 25mg, 50 mg, 100mg and 200 mg.

DRUG

DA414 placebo

DA414 placebo single ascending doses. DA414 placebowill be orally administrated at single ascending doses of 25mg, 50 mg, 100mg and 200 mg.

Sponsors & Collaborators

  • Chendu DIAO Nine Hong Pharmaceutical Factory

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-06
Primary Completion
2025-09-30
Completion
2026-09-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06525168 on ClinicalTrials.gov