Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06637865
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
A First-in-human Study of the Safety of an Immunosuppressive Antibody IMP761 in Healthy Volunteers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Placebo-controlled Double-blind Phase I Study in Healthy Volunteers With IMP761 a LAG-3 Agonist Antibody
Status:
RECRUITING
Status Verified Date:
2024-10
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 goal of this clinical trial is to evaluate the safety and tolerability of single and multiple doses of IMP761 in healthy female and male volunteers aged 18-55 with no history of disease affecting the immune system or recent use of medication with effects on the immune system
The main question it aims to answer is
- if IMP761 is safe and tolerable as determined by assessing vital signs emerging serious adverse events electrocardiography and clinical laboratory tests
Researchers will compare IMP761 to a placebo a look-alike substance that contains no drug to see if single and multiple doses of IMP761 are safe and tolerable in healthy volunteers Part B of the study also investigates the effect of IMP761 on the inhibition of the keyhole limpet haemocyanin KLH driven immune response compared with placebo
Participants will
receive IMP761 or a matching placebo once in single dose part A and B and three times in multiple dose part C during a 4 day in clinic stay with 4-8 following visits
receive KLH challenge
be monitored for up to 103 days after the first dose
The main question it aims to answer is
- if IMP761 is safe and tolerable as determined by assessing vital signs emerging serious adverse events electrocardiography and clinical laboratory tests
Researchers will compare IMP761 to a placebo a look-alike substance that contains no drug to see if single and multiple doses of IMP761 are safe and tolerable in healthy volunteers Part B of the study also investigates the effect of IMP761 on the inhibition of the keyhole limpet haemocyanin KLH driven immune response compared with placebo
Participants will
receive IMP761 or a matching placebo once in single dose part A and B and three times in multiple dose part C during a 4 day in clinic stay with 4-8 following visits
receive KLH challenge
be monitored for up to 103 days after the first dose
Detailed Description:
This is a first in human randomized prospective single centre double blind placebo-controlled study in healthy volunteers It consists of three separate parts Part A B and C with different study designs
The main objective is to evaluate the safety tolerability pharmacokinetics and pharmacodynamics of single ascending dose SAD Part A and B and multiple ascending doses MAD Part C of IMP761 as assessed by
Vital signs
Treatment-emergent serious adverse events SAEs
Electrocardiography
Clinical laboratory tests
Laser speckle contrast imaging LSCI
Multispectral skin imaging
Part A SAD study in healthy subjects cohort 1 5 subjects Cohort 1 5 subjects single dose of IMP76 or placebo 32 The first 2 subjects will receive IMP761 or placebo 11 as sentinel dosing while the following 3 subjects will receive IMP761 or placebo 21
Part B SAD study in healthy subjects KLH challenge cohort 2-5 30 subjects Cohort 2-3 5 subjects single dose of IMP761or placebo 41 Cohort 4-5 10 subjects single dose of IMP761 or placebo 82
Part C MAD study in healthy subjects cohort 6-7 14 subjects Cohort 6-7 7 subjects multiple three doses of IMP761 or placebo 52 IMPplacebo administration every 28 days dose selection to be based on observed pharmacodynamic effects in part B
The main objective is to evaluate the safety tolerability pharmacokinetics and pharmacodynamics of single ascending dose SAD Part A and B and multiple ascending doses MAD Part C of IMP761 as assessed by
Vital signs
Treatment-emergent serious adverse events SAEs
Electrocardiography
Clinical laboratory tests
Laser speckle contrast imaging LSCI
Multispectral skin imaging
Part A SAD study in healthy subjects cohort 1 5 subjects Cohort 1 5 subjects single dose of IMP76 or placebo 32 The first 2 subjects will receive IMP761 or placebo 11 as sentinel dosing while the following 3 subjects will receive IMP761 or placebo 21
Part B SAD study in healthy subjects KLH challenge cohort 2-5 30 subjects Cohort 2-3 5 subjects single dose of IMP761or placebo 41 Cohort 4-5 10 subjects single dose of IMP761 or placebo 82
Part C MAD study in healthy subjects cohort 6-7 14 subjects Cohort 6-7 7 subjects multiple three doses of IMP761 or placebo 52 IMPplacebo administration every 28 days dose selection to be based on observed pharmacodynamic effects in part B
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