Menu
Recruiting NCT07143318

First-in-Human Single and Multiple Dose of KLA578-1 for Injection

Phase I Interventional Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KLA578-1 for injection, Etopcoxib Tablets.
Who it may be relevant to
Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of KLA578-1 for Injection in Healthy Volunteers

Overview

The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of single and multiple doses of KLA578-1 for injection in healthy volunteers

Detailed description

"The study will be carried out in 2 parts. Part 1: This is a open-label, single ascending dose (SAD) escalation study with a total of 3 dose groups, i.e., Groups 1 to 3. There are a total of 12 volunteers in each group with a similar male to female ratio. Groups 1 and 3 are single-arm study, all volunteers will receive the experimental drug ""KLA578-1 for Injection"" ; Group 2 is a randomized, two-treatment, two-period, crossover study, 12 volunteers will be randomized to TR sequence or RT sequence with 6 volunteers in each sequence. The experimental drug ""KLA578-1 for injection"" will be administered in the TR sequence of Period 1, the control drug ""Etopcoxib Tablets"" will be administered to the RT sequence. After 7 days of washing, the control drug ""Etocoxib Tablets"" will be administered in the TR sequence, and the experimental drug ""KLA578-1 for Injection"" will be administered in the RT sequence.

Part 2: This is a open-label, single-arm multiple dose study. A dose group is temporarily set up, with a total of 12 volunteers enrolled, and the male-to-female ratio will be similar. Volunteers will receive the experimental drug ""KLA578-1 for Injection"" 120 mg once daily (every 24 h ± 2 min with reference to the dosing time on D1) under fasting conditions (fasting for at least 10 hours) from D1 to D5; Drinking water is prohibited from 1 h before each dose to 1 h postdose, and fasted within 4 hours after dosing on D1 and D5."

Interventions

  • Drug KLA578-1 for injection
    Intravenous injection, single dose
  • Drug Etopcoxib Tablets
    P.O., single dose

Primary outcome measures

  • Incidence and severity of adverse events (AEs) [Time frame: Up to day 13]
Secondary outcome measures (7)
  • PK parameter Cmax [Time frame: single dose：up to Day 6 ; multiple doses: up to Day 8]
  • PK parameter Tmax [Time frame: single dose：up to Day 6 ; multiple doses: up to Day 8]
  • PK parameter Cmin,ss [Time frame: multiple doses: up to Day 1]
  • PK parameter AUC0-t [Time frame: single dose：up to Day 6 ; multiple doses: up to Day 8]
  • PK parameter AUC0-∞ [Time frame: single dose：up to Day 6 ; multiple doses: up to Day 8]
  • PK parameter AUCtau,ss [Time frame: multiple doses: up to Day 1]
  • PK parameter t1/2 [Time frame: single dose：up to Day 6 ; multiple doses: up to Day 8]

Eligibility criteria

Inclusion criteria

  • Health Volunteers (Age: 18\~45 years);
  • Body Weight: Male≥50.0kg, Female≥45.0kg; 19.0 ≤BMI≤ 26.0;
  • There were no abnormalities in clinically significant physical examination, vital signs, 12-lead electrocardiogram, laboratory tests;
  • Heart rate ≥ 60 bpm and pulse ≥ 60 beats/min.

Exclusion criteria

  • Allergy or Drug hypersensitivity;
  • Clinically significant Medical History;
  • Gastrointestinal ulcers or gastrointestinal bleeding;
  • History of any surgery within 4 weeks;
  • History of any Medication within 14 days;
  • History of any inducers or inhibitors of major CYP450 enzymes within 30 days;
  • History of any clinical study within 3 months;
  • History of any vaccine within 1 month;
  • History of any drug abuse;
  • Tablet dysphagia;
  • Needle sickness, Hematosickness;
  • Massive blood loss (> 200 mL) in the past 3 months;
  • Female volunteers are pregnant or lactating;
  • History of unprotected sex within 2 weeks;
  • Special requirements for diet;
  • Heavy smoker ( more than 3 cigarettes/day) within 3 months;
  • History of alcohol abuse,or heavy alcohol intake (more than 14 units a week) within 6 months;
  • Heavy caffeine intake;
  • History of grapefruit, xanthine-rich foods intake within 7 days;
  • Positive alcohol test;
  • Positive drugs of abuse test result.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Third Xiangya Hospital of Central South University — Changsha

Identifiers

NCT: NCT07143318 · KLA578-1-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗