NCT07143331

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

A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetic Profile of Single and Multiple Ascending Doses of KS101 in Healthy Volunteers, Including a Pilot Food Effect Evaluation

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Klotho Sciences Australia Pty Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a Phase 1, 3-part study to evaluate the safety, tolerability, and pharmacokinetic (PK) profile following the oral administration of single and multiple ascending doses of KS101 in healthy participants, including a food effect evaluation. Part 1 will include six single ascending dose cohorts of 8 participants per cohort (randomised 6 active, 2 placebo). For each cohort, a sentinel group of 2 participants (1 active, 1 placebo) will be dosed first. These participants will be on study for up to 59 days in total. Part 2 will be a crossover evaluation, with and without food (randomised sequence). 12 participants will receive 2 doses of KS101 72 hours apart, one dose under fasting conditions and one dose under fed conditions. These participants will be on study for up to 61days in total. Part 3 will include three multiple ascending dose cohorts of 8 participants per cohort (randomised 6 active, 2 placebo). These participants will receive one dose for 5 consecutive days and will be on study for up to 63 days in total.

Conditions

• Healthy Participants
• Alzheimer Disease
• Chronic Kidney Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-08-30
• Primary completion: 2026-04-01
• Completion: 2026-08-06
• First posted: 2025-08-27
• Last updated: 2025-08-27

Locations

1 site across 1 country: Australia