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COMPLETED
NCT06363851
PHASE1

Single-ascending Dose Study of Kylo-11 in Healthy Subjects

Sponsor: Kylonova (Xiamen) Biopharma co., LTD.

View on ClinicalTrials.gov

Summary

This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy volunteers. Approximately 60 subjects with baseline Lp(a) levels of 75-200 nmol/L are enrolled in the SAD part including dose levels of 9 mg, 30 mg, 75 mg, 225 mg, 450 mg, and 600 mg (Cohort 1-6) to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) effects of Kylo-11. Additionally, the dose of 225 mg is further evaluated in healthy participants with baseline Lp(a) level\>200 nmol/L (Cohort 7).

Official title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Kylo-11 in Healthy Subjects

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

71

Start Date

2024-05-16

Completion Date

2025-12-07

Last Updated

2026-06-26

Healthy Volunteers

Yes

Interventions

DRUG

Kylo-11

Administered SC.

DRUG

Placebo

Administered SC.

Locations (1)

Chengdu Xinhua Hospital

Chengdu, Sichuan, China