NCT05795192

SB17170 Phase1 Trial in Healthy Volunteer

A Randomized, Double-blind, Placebo-controlled, Single and Multiple Dosing, Dose-escalation, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, PK/PD, Food Effect, and Ethnicity Effect of SB17170 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: SPARK Biopharma · Industry
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This clinical trial aims to learn about the safety, tolerability, and pharmacokinetic properties of SB17170 and its active metabolite SB1703 in single and multiple oral administration in healthy adults. The main questions it aims to answer are the safety, tolerability, and PK characteristics of SB17170 in healthy adults.

Detailed description

This clinical trial aims to learn about the safety, tolerability, and Pharmacokinetic properties of SB17170 and its active metabolite SB1703 in single and multiple oral administration in healthy adults. The main questions it aims to answer are the safety, tolerability, and PK characteristics of SB17170 in healthy adults. The second questions are * To explore biomarkers and evaluate pharmacodynamic properties with ex-vivo test and proteome assay for SB17170 * To evaluate the effects of ethnic differences on the safety, tolerability, and pharmacokinetic properties of SB17170 in healthy Korean and Caucasian adults. * To evaluate the effect of food between Fast and high-fat meals on safety, tolerability, and pharmacokinetic properties of SB17170 in healthy adults. The difference between SB17170 and placebo on safety, tolerability, and PK/PD properties will be evaluated.

Conditions

• Safety Issues
• Tolerability
• Pharmacokinetics
• Pharmacodynamics

Interventions

Type	Name	Description
DRUG	SB17170	Taking SB17170 orally once a day
DRUG	Placebo	Taking Placebo orally once a day

Timeline

• Start date: 2023-05-24
• Primary completion: 2024-02-29
• Completion: 2024-03-15
• First posted: 2023-04-03
• Last updated: 2024-03-21

Locations

1 site across 1 country: South Korea