This is a Phase Ib clinical study to evaluate the safety, tolerance, pharmacokinetics and efficacy of AK101 in subjects with moderately to severely active ulcerative colitis.
This is a phase Ib, randomized, double-blind, placebo-controlled, dose-escalation, two-phase study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of AK101 in subjects with moderately to severely active ulcerative colitis. The study consists of two parts. Part 1 is single-ascending-dose induction phase study, and Part 2 is a multiple subcutaneous maintenance therapy study followed by a single-dose induction treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
34
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Adverse Events
Percentage of subjects with treatment-emergent adverse events (TEAEs) during the study.
Time frame: From the time of signing the informed consent form till last follow-up visit (Up to Week 12 or Week36)
Adverse Events
Percentage of subjects with treatment-emergent serious adverse events (SAEs) during the study.
Time frame: From the time of signing the informed consent form till last follow-up visit (Up to Week 12 or Week36)
Elimination half-life (T1/2) of AK101
Assessment of half-life (T1/2) of AK101
Time frame: Baseline till last follow-up visit (Up to Week12 or Week36)
Mean residence time (MRT) of AK101
Assessment of mean residence time (MRT) of AK101
Time frame: Baseline till last follow-up visit (Up to Week12 or Week36)
Area under curve (AUC) of AK101
Assessment of area under curve (AUC) of AK101
Time frame: Baseline till last follow-up visit (Up to Week12 or Week36)
Apparent distribution volume (VD/F) of AK101
Assessment of apparent distribution volume (VD/F) of AK101
Time frame: Baseline till last follow-up visit (Up to Week12 or Week36)
Systemic clearance (CL/F) of AK101
Assessment of systemic clearance (CL/F) of AK101
Time frame: Baseline till last follow-up visit (Up to Week12 or Week36)
Maximum (peak) plasma concentration (Cmax) of AK101
Assessment of maximum (peak) plasma concentration (Cmax)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
AK101 will be administered as intravenous infusion at Week8, then subcutaneously every 8 weeks thereafter .
Nanfang Hospital
Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of Sun Yat-Sen University
Guanzhou, Guangdong, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
People's Hospital of Wuhan University
Wuhan, Hubei, China
Nanjing First Hospital
Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Shengjing Hospital of China Medical University
Shengyang, Liaoning, China
...and 2 more locations
Time frame: Baseline till last follow-up visit (Up to Week12 or Week36)
Time to maximum plasma concentration (Tmax) of AK101
Assessment of Time to maximum plasma concentration (Tmax)
Time frame: Baseline till last follow-up visit (Up to Week12 or Week36)
Proportion of subjects with clinical response at Week8(per Adapted Mayo Score without physician's global assessment).
Clinical response(per Adapted Mayo Score) was defined as a decrease from induction baseline in the adapted Mayo score by≥30 percent (%) and ≥ 2 points, with either a decrease from baseline in the rectal bleeding subscore ≥1 or a rectal bleeding subscore of 0 or 1. Adapted Mayo Score consists of 3 subscores (stool frequency, rectal bleeding and endoscopy findings), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 3 subscores and values range from 0 to 9 scores.
Time frame: At week 8
Proportion of subjects with clinical response at Week8(per the Mayo score).
Clinical response(per the Mayo Score) was defined as a decrease from induction baseline in the Mayo score by ≥30 percent (%) and ≥ 3 points, with either a decrease from baseline in the rectal bleeding subscore ≥1 or a rectal bleeding subscore of 0 or 1. The Mayo Score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 4 subscores and values range from 0 to 12 scores.
Time frame: At week 8
Immunogenicity index
Number and percentage of subjects with detectable anti-AK101 antibody (ADA).
Time frame: Baseline till last follow-up visit (Up to Week 12 or Week36)