Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-01-01 @ 3:12 AM
Study NCT ID:
NCT06996704
Status:
RECRUITING
Last Update Posted:
2025-05-30
First Post:
2025-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study of AK0610
Sponsor:
Shanghai Ark Biopharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation, and Expansion Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of AK0610 in Healthy Chinese Adults.
Status:
RECRUITING
Status Verified Date:
2025-04
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 study consists of two parts: dose escalation and expansion. It includes five cohorts in the dose-escalation phase and two expansion cohorts based on pharmacokinetic data.
Detailed Description:
This study is a Phase I clinical trial that is randomized, double-blind, placebo-controlled, and involves single-dose administration, dose-escalation, and an expansion phase. It evaluates the safety, tolerability, and pharmacokinetic profile of AK0610 in healthy Chinese adults.
The study consists of two parts. The dose-escalation phase includes five cohorts (100 mg i.m.; 300 mg i.m.; 300 mg i.v.; 1000 mg i.v.; 3000 mg i.v.), each consisting of 8 individuals (AK0610: Placebo = 3:1), who are administered doses in sequential increments.
Based on pharmacokinetic data, the dose-escalation phase will be expanded to include two additional dose cohorts (300 mg i.m.; 600 mg i.m.) of 48 individuals each (AK0610: Placebo = 3:1).
Each participant will undergo a Screening Period from Day -29 to Day -1. They will receive one dose on Day 1, an Inpatient Observation Period from Day -1 to Day 8, and a Blinded Follow-Up Period from Day 9 to Day 181. Subjects in the AK0610 group will also enter an open-label period from Day 182 to Day 361.
The study consists of two parts. The dose-escalation phase includes five cohorts (100 mg i.m.; 300 mg i.m.; 300 mg i.v.; 1000 mg i.v.; 3000 mg i.v.), each consisting of 8 individuals (AK0610: Placebo = 3:1), who are administered doses in sequential increments.
Based on pharmacokinetic data, the dose-escalation phase will be expanded to include two additional dose cohorts (300 mg i.m.; 600 mg i.m.) of 48 individuals each (AK0610: Placebo = 3:1).
Each participant will undergo a Screening Period from Day -29 to Day -1. They will receive one dose on Day 1, an Inpatient Observation Period from Day -1 to Day 8, and a Blinded Follow-Up Period from Day 9 to Day 181. Subjects in the AK0610 group will also enter an open-label period from Day 182 to Day 361.
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?:
False
Is an FDA AA801 Violation?: