Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545162
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Safety Tolerability and Pharmacokinetics of a Single or Multiple Ascending Doses of CPX101
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Dose Escalation Phase I Trial to Evaluate the Safety Tolerability and Pharmacokinetics of CPX101 in Healthy Volunteers and Overweight or Obese Patients With Multiple Doses
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized double-blind placebo-controlled Phase I clinical study was designed to evaluate the tolerability and safety PK profile immunogenicity of CPX101 in a single dose in healthy participants and multiple doses in overweight and obese patients and to initially explore the efficacy of multiple doses in weight loss The study was divided into two parts single administration and dose escalation SAD and multiple administration and dose escalation MAD
Detailed Description:
SAD Three dose levels 80mg 120mg and 160mg were preset for this phase and a total of 24 healthy participants were planned to be included According to the dose increment principle starting from the dose of 80mg increasing successively to the high dose and proceeding in sequence
MAD The study was planned to include 48 adult overweight or obese participants with a preset group of four cohorts each with 12 participants All cohorts were dosed with titration starting at 40mg and given once a week QW in each cohort Up to the target dose of 80mgQ2W 120mg Q2W and 160mg Q2W
MAD The study was planned to include 48 adult overweight or obese participants with a preset group of four cohorts each with 12 participants All cohorts were dosed with titration starting at 40mg and given once a week QW in each cohort Up to the target dose of 80mgQ2W 120mg Q2W and 160mg Q2W
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None