NCT05619770

Study to Evaluate Pharmacokinetics, Safety & Tolerability of 101-PGC-005 in Healthy, Adult, Human Subjects

A Single Arm, Open Label, Single Dose and Multiple Dose Study to Evaluate Pharmacokinetics, Safety & Tolerability of 101-PGC-005 in Healthy, Adult, Human Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: 101 Therapeutics · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The goal of this interventional study is to evaluate the pharmacokinetics, safety, and tolerability of 101-PGC-005 in healthy, adult, human subjects. The main question it aims to answer is what are the single and multi-dose PK properties of 101-PGC-005 in the systemic circulation Participants will receive a bolus injection of 101-PGC-005 administered intravenously once daily for 3 consecutive days. Blood and urine samples will be collected at predetermined timepoints for analysis.

Conditions

• Glucocorticoids Toxicity
• COVID-19
• Infectious Disease
• Virus Diseases

Interventions

Type	Name	Description
DRUG	101-PGC-005	Bolus Injection containing 30mg of 101-PGC-005 will administered intravenously once daily for 3 consecutive days

Timeline

• Start date: 2022-10-29
• Primary completion: 2022-11-03
• Completion: 2023-01-15
• First posted: 2022-11-17
• Last updated: 2022-12-14

Locations

1 site across 1 country: India