Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT06716905
Status:
RECRUITING
Last Update Posted:
2025-11-17
First Post:
2024-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, and Pharmacokinetics of ACT500 in Healthy Adult Participants
Sponsor:
Xiamen Amoytop Biotech Co., Ltd.
Organization:
Study Overview
Official Title:
A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Dose Escalations of ACT500 (Formerly Known as NM6606) in Chinese Healthy Adult Participants
Status:
RECRUITING
Status Verified Date:
2025-11
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 single-center, randomized, double-blind, placebo-controlled Phase I clinical study, divided into two parts. The first part is a single-dose escalation study (Part1,SAD study phase), and the second part is a multiple-dose escalation study (Part2,MAD study phase). It's aimed to evaluate the safety, tolerability, and pharmacokinetics (PK) of ACT500 in healthy adult participants, and to explore possible metabolites and biomarkers of ACT500.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: