MedTrace Logo

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

NCT05619770 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-12-14

No results posted yet for this study

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

Interventions

DRUG

101-PGC-005

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

Sponsors & Collaborators

  • 101 Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-29
Primary Completion
2022-11-03
Completion
2023-01-15

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05619770 on ClinicalTrials.gov