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

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/09/045647

Enrollment

Registered

2022-09-19

Start date

Unknown

Completion date

Unknown

Last updated

2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: 101-PGC-005: Bolus Injection containing 30mg of 101-PGC-005 will administered intravenously once daily for 3 consecutive days While subjects are in sitting posture under yellow monochro

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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. 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.	—

Measure

Time frame

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. 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.

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Secondary

Measure	Time frame
1 To monitor the overall safety, tolerability profile of the 101-PGC-005 injection in healthy adult human subjects under fasting conditions. 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. 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	—

Measure

Time frame

1 To monitor the overall safety, tolerability profile of the 101-PGC-005 injection in healthy adult human subjects under fasting conditions. 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. 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

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Countries

India

Contacts

Public ContactDr Harish S

ICBio Clinical Research Pvt. Ltd.

harish@icbiocro.com9900111997

Outcome results