Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:27 AM
Study NCT ID:
NCT07373457
Status:
RECRUITING
Last Update Posted:
2026-01-28
First Post:
2026-01-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study of HW201877 in Healthy Subjects
Sponsor:
Wuhan Humanwell Innovative Drug Research and Development Center Limited Company
Organization:
Study Overview
Official Title:
A Single-Center, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dosing, Dose-escalation, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, PK/PD, Food Effect of HW201877 in Healthy Volunteers.
Status:
RECRUITING
Status Verified Date:
2026-01
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 Phase I, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and food effect (FE) of HW201877 in healthy subjects following (1) a single ascending dose (Part 1), which includes a single-dose, two-period crossover FE cohort; (2) a multiple ascending dose (Part 2).
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?: