Ignite Creation Date:
2024-05-06 @ 3:25 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04629131
Status:
COMPLETED
Last Update Posted:
2022-11-07
First Post:
2020-11-05
Brief Title:
Safety Tolerability Pharmacokinetics and Pharmacodynamics of TNM002 in Healthy Adults
Sponsor:
Zhuhai Trinomab Pharmaceutical Co Ltd
Organization:
Zhuhai Trinomab Pharmaceutical Co Ltd
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Dose-Escalation Phase I Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics Following Intramuscular Administration of a Single Dose of TNM002 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2022-11
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 purpose of this study is to evaluate the safety tolerability pharmacokinetics and pharmacodynamics properties of TNM002 following a single intramuscular dose in healthy adult subjects
Detailed Description:
The study a randomized double-blinded placebo-controlled dose-escalation phase I trial A total of 32 healthy adult subjects will be enrolled into 4 cohorts sequentially Each participant will receive a single IM dose of TNM002 or placebo according to the cohort in which they were enrolled After injection Day 1 participants remain in the study site for observation up to 5 days Following completion of the safety assessments and sampling for PKPD analyses on Day 4 participants will be discharged from the study site On Day 8 15 29 43 64 and 85 participants will return for safety assessments
Study Oversight
Has Oversight DMC:
None
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?:
None