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Phase 1, Single-Dose and Multiple-Dose Continuous Intravenous Infusions of TNP-2092 for Injection in Healthy Chinese Participants

NCT06394518 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-05-01

No results posted yet for this study

Summary

This is a phase 1, single-center, randomized, double-blind, placebo-controlled, dose-escalation clinical trial of single and multiple intravenous doses of TNP-2092 for injection in healthy Chinese participants.

Conditions

  • Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
  • Prosthetic Joints Infection (PJI)

Interventions

DRUG

TNP-2092 for injection

The study had 3 dose groups, a 200 mg single dose group (low-dose group), a 300 mg single and multiple dose continuous dose group (medium-dose group), and 400 mg single dose group (high-dose group)

DRUG

placebo

The placebo for TNP-2092 active drug

Sponsors & Collaborators

  • TenNor Therapeutics Inc.

    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
2022-07-07
Primary Completion
2023-02-24
Completion
2023-02-24
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

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 NCT06394518 on ClinicalTrials.gov