Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06560593
PHASE1

A Phase 1 Clinical Trial of NTQ5082 in Healthy Volunteers

Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical

View on ClinicalTrials.gov

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.

Official title: A Randomized, Double-blind, Placebo-controlled, Dose Escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics Characteristics of NTQ5082 Capsules Orally Administered in Healthy Volunteers in Single and Multiple Doses

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

82

Start Date

2024-08

Completion Date

2025-02

Last Updated

2024-08-19

Healthy Volunteers

Yes

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.

Locations (1)

The Third hospital of Changsha

Changsha, Hunan, China