Ignite Creation Date:
2024-07-17 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494527
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-02
Brief Title:
A Phase 1 Study to Evaluate the SafetyTolerability PKPD of RG002C0106 Injection in Healthy Adults
Sponsor:
Rigerna Therapeutics Beijing Rigerna Therapeutics Suzhou Rigerna OA Therapeutics Pty Ltd
Organization:
Rigerna Therapeutics Beijing Rigerna Therapeutics Suzhou Rigerna OA Therapeutics Pty Ltd
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled SingleMultiple Ascending Dose Phase 1 International Multi-center Clinical Study to Evaluate the SafetyTolerability PharmacokineticsPharmacodynamics of RG002C0106 Injection in Healthy Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
This is a randomized double-blind placebo-controlled study to evaluate the safety tolerability and PKPD profiles of RG002C0106 injection in healthy adult subjects The study will be divided into the following parts
Part A conducted SAD stage Part B conducted MAD stage
Part A conducted SAD stage Part B conducted MAD stage
Detailed Description:
This is a randomized double-blind placebo-controlled study to evaluate the safety tolerability and PKPD profiles of RG002C0106 injection in healthy adult subjects The study will be divided into the following parts
Part A conducted SAD stage Part B conducted MAD stage There are 5 cohorts for the SAD escalation scheme Dose escalation will start with the planned lowest dose 25mgand the highest dose will be mainly determined based on the data obtained during the study process
There are 3 cohorts for the MAD stage The doses for these 3 cohorts are low dose medium dose and high dose respectively
Part A conducted SAD stage Part B conducted MAD stage There are 5 cohorts for the SAD escalation scheme Dose escalation will start with the planned lowest dose 25mgand the highest dose will be mainly determined based on the data obtained during the study process
There are 3 cohorts for the MAD stage The doses for these 3 cohorts are low dose medium dose and high dose respectively
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