NCT03953092

A Randomized, Double-blind, Placebo-controlled, Sequential Single and Multiple Ascending Doses of YG1699

A Randomized, Double-blind, Placebo-controlled, Sequential Single and Multiple Ascending Doses (SAD/MAD) Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of YG1699

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Youngene Therapeutics Inc., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) of YG1699 following single and multiple ascending oral dose administration.

Detailed description

This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) of YG1699 following single and multiple ascending oral dose administration. The study consists of 2 parts: Part 1, SAD dose-escalation; Part 2, MAD dose-escalation.

Conditions

• Diabete Mellitus

Interventions

Type	Name	Description
DRUG	YG1699	YG1699 at Multiple Doses
DRUG	Placebos	Placebos

Timeline

• Start date: 2019-05-01
• Primary completion: 2019-11-13
• Completion: 2019-11-13
• First posted: 2019-05-16
• Last updated: 2021-01-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study