NCT07343323

A First-in-Human Study of KINE-101 in Healthy Volunteers

A Randomized, Single Center, Double-blind, Placebo-controlled, First in Human Study With Single Ascending Doses to Determine Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Infusion and Subcutaneous Injections of KINE-101 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Kine Sciences Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study that evaluates the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of intravenous (IV) and subcutaneous (SC) formulations of KINE-101 in healthy volunteers at a single study center. Five cohorts of eight subjects each (six receiving KINE-101 and two receiving placebo) are admitted on Day -1, receive a single dose of investigational medicinal product (IMP) on Day 1, and remain in-house until Day 3, followed by outpatient visits on Days 7, 14, 28, and 42. Sentinel dosing applies in the first sub-cohort of each cohort: two sentinel subjects are dosed at least 10 minutes apart, and if no safety concerns arise during the 48-hour post-dose evaluation period, the remaining subjects in the cohort are subsequently dosed. Dosing in the second sub-cohort also occurs at intervals of at least 10 minutes. Four cohorts receive the IV formulation, with doses escalating from 10 mg up to an anticipated maximum of 300 mg. To compare relative bioavailability and characterize PK after subcutaneous administration, one SC cohort receives a single 96.8 mg dose. The number of cohorts and dose progression depend on emerging safety and PK data. Decisions to escalate, repeat, or modify dose levels are made by the Safety Review Committee (SRC), and additional cohorts may be added if deemed necessary.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	KINE-101	KINE-101 injection, 12.5 mg/mL, administered once either intravenously (10 mg, 30 mg, 100 mg, or 300 mg) or subcutaneously (96.8 mg) on Day 1, depending on cohort.
DRUG	Placebo	Sterile 0.9% sodium chloride solution, administered once intravenously or subcutaneously on Day 1, matching the route of the investigational product.

Timeline

• Start date: 2021-11-05
• Primary completion: 2023-01-31
• Completion: 2023-01-31
• First posted: 2026-01-15
• Last updated: 2026-01-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study