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Low dose KT07 for Pharmacokinetics

Phase 1
Waitlist Available
Research Sponsored by Yiling Pharmaceutical Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 19 days
Awards & highlights

Study Summary

This is a phase 1 single-center study to assess the pharmacokinetics (PK), safety and tolerability of KT07 capsules in healthy adult subjects. This study consists of 2 parts: Part 1 and Part 2. The primary objectives of Part 1 include selection of suitable PK markers for bioanalysis, development and validation of GLP bioanalytical methods for follow-up PK studies, assessment of PK of potential markers following an oral administration of KT07, and provision of PK sampling strategy for Part 2. The primary objective of Part 2 is to evaluate the PK profile following a single dose and multiple doses in healthy adult subjects.

Eligible Conditions
  • Healthy Adult Subjects
  • Pharmacokinetics
  • Safety and Tolerability

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~19 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 19 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC (Racc_AUCss)
AUC0-∞
AUCextrap
+9 more
Secondary outcome measures
Causality of adverse events
Incidence of adverse events
Severity of adverse events

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Low dose KT07Experimental Treatment1 Intervention
KT07 single dose (4 capsules) followed by multiple doses for 5 days (tid)
Group II: High dose KT07Experimental Treatment1 Intervention
KT07 single dose (6 capsules) followed by multiple doses for 5 days (tid)
Group III: Low dose placeboPlacebo Group1 Intervention
Placebo single dose (4 capsules) followed by multiple doses for 5 days (tid)
Group IV: High dose placeboPlacebo Group1 Intervention
Placebo single dose (6 capsules) followed by multiple doses for 5 days (tid)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Low dose KT07
2022
Completed Phase 1
~30
High dose KT07
2022
Completed Phase 1
~30

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Yiling Pharmaceutical Inc.Lead Sponsor
4 Previous Clinical Trials
519 Total Patients Enrolled
Nan Zhang, PhDStudy DirectorYiling Pharmaceutical

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Phase I Pharmacokinetics Study for KT07 Capsule
2022. "A Phase I Pharmacokinetics Study for KT07 Capsule". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05223660.
~8 spots leftby Apr 2025
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