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

Phase 1

Completed

• Registration Number: CTRI/2022/09/045647
• Lead Sponsor: AXAI LIFE SCIENCES PVT LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-11-03
• Last Update Posted: 3 April 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

1 Able to comprehend the nature and purpose of the study and willing to give audio-visual & written informed consent for participation in the study.

2 Willing to be available for the entire study period and to comply with protocol requirements.

3 Normal, healthy, adult, human subject of 18-45 years (both inclusive) of age.

4 Body mass index in the range of 18 â?? 30 kg/m2 (both inclusive).

Exclusion Criteria

1 Has consumed dexamethasone or any other corticosteroid oral or intravenous for any reasons in past 4 weeks before study entry.

2 Use of any Investigational vaccine within the last three years except for Covid-19 vaccines.

3 Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or bloodâ??forming organs.

4 History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1 Single-dose PK: Quantification of 101-PGC-005 concentration available in systemic circulation (blood/plasma) in all recruited subjects; pre- and post- dosing with 101-PGC-005 injection on Day 1. <br/ ><br>2 Multiple-dose PK: Quantification of 101-PGC-005 concentration available in systemic circulation (blood/plasma) in all recruited subjects; pre- and post- dosing with 101-PGC-005 injection on Day 3Timepoint: 30 min. pre-dose and 30 min., 45 min, 1, 1.5, 2, 3, 6, 9, 12, 24 hours post-dose.

Secondary Outcome Measures

Name	Time	Method
1 To monitor the overall safety, tolerability profile of the 101-PGC-005 injection in healthy adult human subjects under fasting conditions. <br/ ><br>2 To evaluate free dexamethasone levels available in systemic circulation (blood/plasma) in all recruited subjects, pre- and post- dosing with 101-PGC-005 injection on Day 1, Day 3. <br/ ><br>3 â?¢To evaluate the incidence of steroid-induced hyperglycemia events after 101-PGC-005 administration till day 5 of first dose.Timepoint: From day 1 to day 5