Ignite Creation Date:
2024-07-17 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498284
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-04-30
Brief Title:
Evaluate HM-002-1005 in Subjects With Type 2 Diabetes Mellitus
Sponsor:
Hua Medicine Limited
Organization:
Hua Medicine Limited
Study Overview
Official Title:
HM-002-1005 - A Phase 1 Randomized Double Blind Placebo Controlled Single Dose Safety Tolerability Pharmacokinetic and Pharmacodynamic Study in Subjects With Type 2 Diabetes Mellitus
Status:
RECRUITING
Status Verified Date:
2024-04
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:
The purposes of this study are to
Evaluate the safety and tolerability of the study drug
Measure how much of the study drug HM-002-1005 and its breakdown product get into the bloodstream and how long it takes the body to get rid of them
Measure the amount of glucose blood sugar and a substance called C-peptide in the bloodstream after receiving the study drug
Researchers will compare the study drug to a placebo a look-alike substance that contains no drug
Participants will
Stay 5 days and 4 nights or 6 days and 5 nights at the research site and have a follow-up phone call 7 days after leaving the research site
Take one 1 dose of the study drug or placebo
Have blood taken to measure the amount of study drug and its breakdown product and the levels of glucose and C-peptide
Have safety tests such as vital sign ECGs and glucose measurements
Evaluate the safety and tolerability of the study drug
Measure how much of the study drug HM-002-1005 and its breakdown product get into the bloodstream and how long it takes the body to get rid of them
Measure the amount of glucose blood sugar and a substance called C-peptide in the bloodstream after receiving the study drug
Researchers will compare the study drug to a placebo a look-alike substance that contains no drug
Participants will
Stay 5 days and 4 nights or 6 days and 5 nights at the research site and have a follow-up phone call 7 days after leaving the research site
Take one 1 dose of the study drug or placebo
Have blood taken to measure the amount of study drug and its breakdown product and the levels of glucose and C-peptide
Have safety tests such as vital sign ECGs and glucose measurements
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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