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Dose Escalation Study of Kylo-0603 in Healthy Subjects

NCT06365580 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2024-10-09

No results posted yet for this study

Summary

This clinical trial is the first-in-human study of Kylo-0603. The purpose of this randomized, double-blind, placebo-controlled phase 1 study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and effect of food of Kylo-0603 in healthy Chinese adult subjects.

Conditions

Interventions

DRUG

Kylo-0603 capsule

Administrated orally.

DRUG

Placebo

Administrated orally.

Sponsors & Collaborators

  • Kylonova (Xiamen) Biopharma co., LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-23
Primary Completion
2024-08-16
Completion
2024-08-16

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06365580 on ClinicalTrials.gov