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A Phase 1 Study to Assess the Safety and Effects of Single and Multiple Doses of KS101 in Healthy Volunteers

NCT07143331 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-08-27

No results posted yet for this study

Summary

This study is the first clinical trial involving study drug KS101. The goal of this clinical trial is to investigate whether KS101 is safe, whether it causes side effects, and how KS101 is broken down in the body, in healthy participants.

This information will be used to learn more about KS101 and to determine the most effective dose for age related diseases such as chronic kidney disease and Alzheimer's Disease, with the fewest unwanted side effects.

There are 3 parts to this study. In Part 1, participants will take KS101 or a placebo once and will stay in the study centre for a 4-night inpatient stay. Participants will return for outpatient visits on Days 8 and 29.

In Part 2, participants will take KS101 twice, once after a meal and once without a meal and will stay in the study centre for a 7-night inpatient stay. Participants will return for outpatient visits on Days 11 and 32.

In Part 3, participants will take KS101 or a placebo once daily for 5 days and will stay in the study centre for an 8-night inpatient stay. Participants will return for outpatient visits on Days 12 and 33.

Conditions

Interventions

DRUG

Part 1 KS101

Six doses of oral KS101 will be administered to participants.

DRUG

Part 1 Placebo

Six doses of oral matching placebo will be administered to participants.

DRUG

Part 2 with Food

KS101 administered with food

DRUG

Part 2 without food

KS101 administered without food

DRUG

Part 3 KS101

3 multiple doses of KS101

Sponsors & Collaborators

  • Klotho Sciences Australia Pty Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2025-08-30
Primary Completion
2026-04-01
Completion
2026-08-06

Countries

  • Australia

Study Locations

More Related Trials

Entities

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 NCT07143331 on ClinicalTrials.gov