Ignite Creation Date:
2024-07-17 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06493084
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-03
Brief Title:
Evaluate LAE102 in Healthy Subjects and Subjects With Overweight Obesity
Sponsor:
Laekna Limited
Organization:
Laekna Limited
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Single and Multiple Dose Escalation Phase I Study to Evaluate the Safety Tolerability and Pharmacokinetics of LAE102 in Healthy Subjects and Subjects With OverweightObesity
Status:
RECRUITING
Status Verified Date:
2024-10
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:
The goal of this clinical trial is to learn the safety and tolerability of LAE102 injection in healthy subjects It will also learn about the PKADA and PD status The main questions it aims to answer are
what dose level is safe tolerance and effective in human What medical problems do participants have when taking LAE102 Researchers will compare LAE102 to a placebo saline as placebo to see if LAE102 is safe works to treat obesity in future
Participants will
Receive LAE102 injection or a placebo once in part A part B Expect 6 dose levels for part A and 3 dose levels for part B Be in hospital for 7 days for checkups and blood tests then visit clinic in D11D15D29
what dose level is safe tolerance and effective in human What medical problems do participants have when taking LAE102 Researchers will compare LAE102 to a placebo saline as placebo to see if LAE102 is safe works to treat obesity in future
Participants will
Receive LAE102 injection or a placebo once in part A part B Expect 6 dose levels for part A and 3 dose levels for part B Be in hospital for 7 days for checkups and blood tests then visit clinic in D11D15D29
Detailed Description:
Part A and Part B are randomized double-blind single-dose escalation studies with 6 ivgtt cohorts planned for Part A and 3 subcutaneous cohorts planned for Part B
Eight 8 healthy subjects will be enrolled in each cohort of Parts A and B and subjects are randomized to receive either the investigational drug or placebo in a 6 2 ratio
The start time of Part B is to be carried out will be determined by the Safety Review Committee SRC
The primary objective for both part A part B is to evaluate the safety and tolerability of LAE102 injection in healthy subjects via intravenously guttae The secondary Objectives for both part A part B is to evaluate the pharmacokinetic PK and immunogenicity ADA of LAE102 injection in healthy subjects via intravenously guttae Also to evaluate the change of Activin A after dosing of LAE102 injection in healthy subjects
Subjects will receive intravenously guttae or subcutaneous injection of the investigational product LAE102 then will stay in the Study Site during D1 D7 and receive the corresponding safety examinations and PK sample collection After the data collection on D7 the subjects may leave the Study Site Subjects will return to the Study Site on D11 D15 D29 and receive the corresponding safety examinations and PK sample collection
Eight 8 healthy subjects will be enrolled in each cohort of Parts A and B and subjects are randomized to receive either the investigational drug or placebo in a 6 2 ratio
The start time of Part B is to be carried out will be determined by the Safety Review Committee SRC
The primary objective for both part A part B is to evaluate the safety and tolerability of LAE102 injection in healthy subjects via intravenously guttae The secondary Objectives for both part A part B is to evaluate the pharmacokinetic PK and immunogenicity ADA of LAE102 injection in healthy subjects via intravenously guttae Also to evaluate the change of Activin A after dosing of LAE102 injection in healthy subjects
Subjects will receive intravenously guttae or subcutaneous injection of the investigational product LAE102 then will stay in the Study Site during D1 D7 and receive the corresponding safety examinations and PK sample collection After the data collection on D7 the subjects may leave the Study Site Subjects will return to the Study Site on D11 D15 D29 and receive the corresponding safety examinations and PK sample collection
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?:
False
Is an FDA AA801 Violation?:
None