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

NCT07143318 | Recruiting Phase 1

• 1 other identifier: KLA578-1-101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

Healthy

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events (AEs)

  Up to day 13

Secondary Outcomes (7)

• PK parameter Cmax

  single dose：up to Day 6 ; multiple doses: up to Day 8

• PK parameter Tmax

  single dose：up to Day 6 ; multiple doses: up to Day 8

• PK parameter Cmin,ss

  multiple doses: up to Day 1

• PK parameter AUC0-t

  single dose：up to Day 6 ; multiple doses: up to Day 8

• PK parameter AUC0-∞

  single dose：up to Day 6 ; multiple doses: up to Day 8

Study Arms (4)

KLA578-1 60mg

EXPERIMENTAL

12 volunteers receive KLA578-1 for injection 60mg

Drug: KLA578-1 for injection

KLA578-1 120mg

ACTIVE COMPARATOR

Period 1, 6 volunteers receive KLA578-1 for injection 120mg → 6 volunteers receive Etopcoxib Tablets 120mg; Period 2, 6 volunteers receive Etopcoxib Tablets 120mg → 6 volunteers receive KLA578-1 for injection 120mg

Drug: KLA578-1 for injection; Drug: Etopcoxib Tablets

KLA578-1 240mg

EXPERIMENTAL

12 volunteers receive KLA578-1 for injection 240mg

Drug: KLA578-1 for injection

multiple doses of KLA578-1 for injection

EXPERIMENTAL

12 volunteers receive KLA578-1 for injection 120mg over 5 consecutive days.

Drug: KLA578-1 for injection

Interventions

KLA578-1 for injection DRUG

Intravenous injection, single dose

KLA578-1 120mg; KLA578-1 240mg; KLA578-1 60mg; multiple doses of KLA578-1 for injection

Etopcoxib Tablets DRUG

P.O., single dose

KLA578-1 120mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sichuan Kelun Pharmaceutical Co., Ltd: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 611130, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Wei Qi

CONTACT

028-82339360; qiw@kelun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: August 27, 2025
• Study Start: June 5, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: August 27, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)