NCT07324642

A Phase 1 MAD Study of KINE-101 in Healthy Volunteers

A Randomized, Single-center, Single-blind, Placebo-controlled, Dose Escalation Phase 1 Clinical Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Characteristics of Multiple Intravenous Infusions of KINE-101 in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Kine Sciences Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, single-center, single-blind, placebo-controlled, dose-escalation Phase 1 clinical trial designed to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic characteristics of multiple intravenous (IV) infusions of KINE-101 in healthy adult volunteers. The study includes three sequential cohorts with a total of 24 subjects (8 subjects per cohort; 6 assigned to KINE-101 and 2 to placebo). Subjects in the treatment groups receive KINE-101 once daily for 7 consecutive days at doses corresponding to their assigned cohort (Cohort 1: 120 mg, Cohort 2: 240 mg, Cohort 3: 360 mg). Subjects in the placebo group receive 0.9% saline under identical conditions. All subjects are admitted on Day -1, receive daily dosing from Day 1 through Day 7, and are discharged on Day 9 after completion of safety monitoring. Follow-up visits are conducted on Days 14, 21, 28, and 35. Dose escalation proceeds sequentially from the lowest-dose cohort (Cohort 1) to the highest-dose cohort (Cohort 3). Safety and tolerability data collected through Day 35 in each preceding cohort are reviewed before initiating dosing in the next higher-dose cohort.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	KINE-101	KINE-101 injection, 12.5 mg/mL, intravenous infusion once daily for 7 days under fasting conditions.
DRUG	Placebo	0.9% sodium chloride, intravenous infusion once daily for 7 days under fasting conditions.

Timeline

• Start date: 2025-05-26
• Primary completion: 2025-08-25
• Completion: 2025-08-25
• First posted: 2026-01-07
• Last updated: 2026-01-07

Locations

1 site across 1 country: South Korea