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A Phase 1 Clinical Trial of NTQ5082 in Healthy Volunteers

NCT06560593 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2024-08-19

No results posted yet for this study

Summary

NTQ5082 capsule is a small molecule CFB factor inhibitor. The study is a randomized, double-blind, placebo-controlled, dose escalation phase 1 clinical trial to evaluate the safety, tolerability and PK/PD characteristics of NTQ5082 capsules orally administered in healthy subjects in single and multiple doses.

Conditions

  • Complement-mediated Hemolytic Diseases

Interventions

DRUG

NTQ5082

single ascending dose, randomized, double-blind study，with 8 dose groups preset. The first cohort will be the sentinel group, consisted of 2 subjects receiving NTQ5082 capsules. The remaining cohorts required 8 subjects each, with 6 receiving NTQ5082 capsules and 2 receiving placebo.

DRUG

Placebo

multiple ascending dose, randomized, double-blind study，with 3 dose groups preset. All cohorts required 8 subjects each, with 6 receiving NTQ5082 capsules and 2 receiving placebo.

Sponsors & Collaborators

  • Nanjing Chia-tai Tianqing Pharmaceutical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-08-31
Primary Completion
2024-12-31
Completion
2025-02-28

Countries

  • China

Study Locations

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Entities

Drugs

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 NCT06560593 on ClinicalTrials.gov