Ignite Creation Date:
2024-05-06 @ 3:44 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04732988
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2021-01-19
Brief Title:
A Study to Investigate the Safety Tolerability PharmacokineticPharmacodynamic Characteristics and Food Effect of HSG4112
Sponsor:
Glaceum
Organization:
Glaceum
Study Overview
Official Title:
A Dose-block Randomized Double-blind Placebo-controlled Single and Multiple Dosing Dose-escalation Phase I Clinical Trial to Investigate the Safety Tolerability PharmacokineticPharmacodynamic Characteristics and Food Effect of HSG4112 After Oral Administration in Healthy and Obese Male Subjects
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 Study Objective The objective of this phase 1 clinical trial is to evaluate the safety tolerability pharmacokineticpharmacodynamic characteristics and food effect of HSG4112 after oral administration in healthy male subjects
2 Study Design and Plan This study is a dose-block randomized double-blind placebo-controlled single and multiple dosing dose-escalation phase 1 clinical trial A unique randomization number will be assigned to each subject deemed eligible to participate in the study based on the inclusionexclusion criteria Each subject will be randomized to one of the six groups for the single ascending dose SAD study or one of the three groups for the multiple ascending dose MAD study Each dose group will consist of ten subjects and among the ten subjects eight subjects will be randomized to receive HSG4112 and two subjects will be randomized to receive placebo The subjects will be studied in a double-blind manner and will receive the investigational product ie HSG4112 or placebo via once-daily oral administration The dosing duration for the MAD study is 14 days When escalating the dose the Investigator will review all of the available safety data from the preceding dose in a blinded manner to ensure if it is safe to escalate the dose In order to evaluate safety and tolerability assessments such as vital signs 12-lead electrocardiogram laboratory test semen analysis MAD study only physical examination and adverse event monitoring will be performed Blood samples will be collected to evaluate the pharmacokineticpharmacodynamic characteristics of HSG4112
2 Study Design and Plan This study is a dose-block randomized double-blind placebo-controlled single and multiple dosing dose-escalation phase 1 clinical trial A unique randomization number will be assigned to each subject deemed eligible to participate in the study based on the inclusionexclusion criteria Each subject will be randomized to one of the six groups for the single ascending dose SAD study or one of the three groups for the multiple ascending dose MAD study Each dose group will consist of ten subjects and among the ten subjects eight subjects will be randomized to receive HSG4112 and two subjects will be randomized to receive placebo The subjects will be studied in a double-blind manner and will receive the investigational product ie HSG4112 or placebo via once-daily oral administration The dosing duration for the MAD study is 14 days When escalating the dose the Investigator will review all of the available safety data from the preceding dose in a blinded manner to ensure if it is safe to escalate the dose In order to evaluate safety and tolerability assessments such as vital signs 12-lead electrocardiogram laboratory test semen analysis MAD study only physical examination and adverse event monitoring will be performed Blood samples will be collected to evaluate the pharmacokineticpharmacodynamic characteristics of HSG4112
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None