Literature analysis of the design and results of the First-In-Human clinical trials of drugs from 2009 to 2020
10.12092/j.issn.1009-2501.2022.01.011
- Author:
Kunhong DENG
1
;
Yaxin LIU
1
;
Yuanyuan SUN
1
;
Wenjing CHEN
1
;
Zhanqing HU
1
;
Jie HUANG
1
;
Yuxia XIANG
1
;
Guoping YANG
1
;
Yaxin LIU
2
;
Guoping YANG
2
;
Nan YANG
3
;
Kaifeng CHEN
3
Author Information
1. Center of Clinical Pharmacology, The Third Xiangya Hospital, Central South University
2. Xiangya School of Pharmaceutical Sciences, Central South University
3. Department of Pharmacy, The Third Xiangya Hospital, Central South University
- Publication Type:Journal Article
- Keywords:
Clinical trial;
First-In-Human trials;
Maximum recommended starting dose
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2022;27(1):77-85
- CountryChina
- Language:Chinese
-
Abstract:
AIM: Describe the general situation of the First-In-Human trials of the drugs, and summarize the design and results of the First-In-Human trials. METHODS: We searched the literature of the First-In-Human trials in 2009-2020 on PubMed and screened out the literature that met the research purpose. The basic information of the literature was collected. Data analysis was conducted to summarize relevant outcomes. RESULTS: A total of 559 First-In-Human trials were included in this study. The types of drugs included small molecule drugs (52.42%, 293/559), macromolecule drugs (45.62%, 255/559), and a small amount of cells and viruses (1.97%, 11/559) and so on. Regarding the determination of the starting dose, whether it was in macromolecules (23.86%, 21/88) or small molecules (30.15%, 41/136), No Observed Adverse Effect Level (27.68%, 62/224) was mainly used as the main reference basis, followed by preclinical research (21.88%, 49/224) and Minimal Anticipated Biological Effect Level (8.48%, 19/224), etc. In the dose escalation test, 50.19%(135/269) of the studies used the traditional standard 3+3 dose escalation method, followed by the accelerated titration method (7.06%, 19/269), and the improved 3+3 method (6.69%, 18/269), etc. CONCLUSION: The design of First-In-Human clinical trials has certain regularity in the content and results of the research design. In the subsequent trials, it is important to scientifically design the First-In-Human trials, and promote the safe and effective development of the First-In-Human trials of the drugs.
