Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06610487
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
A Study of FT1 in Healthy Adult Volunteers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Study to Evaluate the Safety Tolerability Pharmacokinetics and Immunogenicity of FT1 in Healthy Adult Volunteers
Status:
RECRUITING
Status Verified Date:
2024-09
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:
The main aim of this clinical trial is to assess the safety of FT1 in participants aged 18 to 45 years The main questions it aims to answer are
Is FT1 safe in healthy adults Researchers will compare FT1 to a placebo a look-alike substance that contains no drug to see if FT1 is safe and active in human
Participants will
Receive one subcutaneous injection or multiple injections of FT1 or placebo according to weight
Visit the clinic for assessment
Is FT1 safe in healthy adults Researchers will compare FT1 to a placebo a look-alike substance that contains no drug to see if FT1 is safe and active in human
Participants will
Receive one subcutaneous injection or multiple injections of FT1 or placebo according to weight
Visit the clinic for assessment
Detailed Description:
This study is a first-in-human study which is a single-center randomized placebo-controlled double-blind dose escalation clinical study aiming to evaluate the safety tolerability pharmacokinetics and immunogenicity of FT1 in healthy adult volunteers
The trial is divided into 2 parts single-dose part and multiple-dose part In multiple-dose part participants will receive once weekly subcutaneous injection of FT1 for 3 weeks
The trial is divided into 2 parts single-dose part and multiple-dose part In multiple-dose part participants will receive once weekly subcutaneous injection of FT1 for 3 weeks
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