Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06564389
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
FIH Study to Evaluate the Tolerability of PF-07832837 in Healthy Adults and Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 First in Human Randomized Double-Blind Sponsor-Open Placebo-Controlled Single- and Multiple Dose Escalation Parallel Group Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of PF 07832837 In Healthy Participants and Participants With Moderate to Severe Atopic Dermatitis
Status:
NOT_YET_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 purpose of the study is to evaluate the safety tolerability and pharmacokinetics of escalating single and repeat doses of PF-07832837 in healthy participants and in participants with moderate to severe atopic dermatitis An additional goal is to assess the pharmacodynamics of PF-07832837 in participants with moderate to severe AD including potential effects on clinical signs and symptoms
Detailed Description:
This is a first-in-human FIH study of PF-07832837 that will be conducted in 2 parts Part 1 will be conducted in healthy adult participants and Part 2 will be conducted in adult participants with moderate to severe AD
Part 1 is within-cohort randomized participant- and investigator-blind sponsor-open placebo-controlled investigation of the safety tolerability PK and immunogenicity following single and multiple ascending doses of PF-07832837 in healthy participants Part 1 may also include a cohort of Japanese healthy adult participants to provide safety tolerability and PK data in Japanese population to enable the inclusion of Japanese participants in future clinical trials
Part 2 is a randomized participant- and investigator-blind sponsor-open placebo-controlled study to investigate the safety tolerability PK and pharmacodynamics including clinical effects of PF-07832837 in participants with moderate to severe AD Part 2 will consist of cohorts of participants with moderate to severe AD A total of approximately 28 participants will receive either active PF-07832837 or placebo
Part 1 is within-cohort randomized participant- and investigator-blind sponsor-open placebo-controlled investigation of the safety tolerability PK and immunogenicity following single and multiple ascending doses of PF-07832837 in healthy participants Part 1 may also include a cohort of Japanese healthy adult participants to provide safety tolerability and PK data in Japanese population to enable the inclusion of Japanese participants in future clinical trials
Part 2 is a randomized participant- and investigator-blind sponsor-open placebo-controlled study to investigate the safety tolerability PK and pharmacodynamics including clinical effects of PF-07832837 in participants with moderate to severe AD Part 2 will consist of cohorts of participants with moderate to severe AD A total of approximately 28 participants will receive either active PF-07832837 or placebo
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