This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and clinical efficacy of ISM5411 in adult patients with active ulcerative colitis.
ISM5411 is a gut-restricted small-molecule prolyl hydroxylase (PHD) inhibitor. It can promote the expression of intestinal mucosal protective genes and maintain the integrity and functions of intestinal barrier together with anti-inflammation. It is expected to become a safe and effective therapy to overcome the shortcomings of traditional simple anti-inflammatory drugs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Dosage Form: Tablet; Frequency of administration: Orally QD.
Dosage Form: Tablet; Frequency of administration: Orally QD.
Dosage Form: Tablet ; Frequency of administration: Orally QD.
The rate of treatment-emergent adverse events (TEAEs) in each group.
To evaluate the safety and tolerability of ISM5411.
Time frame: Week1 to Week12.
The rate of serious adverse events (SAEs) and adverse events (AEs) leading to discontinuation of treatment in each group.
To evaluate the safety and tolerability of ISM5411.
Time frame: Up to 16 weeks.
Changes and comparisons of the following data for each group of subjects: vital signs, physical examination, laboratory test(blood routine, blood chemistry, urinalysis, coagulation function, etc.), ECG(Heart rate, RR, PR, QRS,QT, QTcF ), etc.
To evaluate the safety and tolerability of ISM5411.
Time frame: Up to 16 weeks.
Peak plasma concentration (Cmax)
To evaluate pharmacokinetics (PK) of ISM5411 in moderately to severely active UC patients.
Time frame: Week1 to Week12.
Peak plasma time (Tmax)
To evaluate PK of ISM5411 in moderately to severely active UC patients.
Time frame: Week1 to Week12.
Area under the plasma concentration-time curve extrapolated from time zero to infinity (AUC0-inf).
To evaluate PK of ISM5411 in moderately to severely active UC patients.
Time frame: Week1 to Week12.
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t).
To evaluate PK of ISM5411 in moderately to severely active UC patients.
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Dosage Form: Tablet; Frequency of administration: Orally QD.
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGThe First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGGuangzhou First People's Hospital
Guangzhou, Guangdong, China
RECRUITINGThe First Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGHuizhou First Hospital
Huizhou, Guangdong, China
RECRUITINGThe People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
RECRUITINGThe Second Hospital of HeBei Medical University
Shijiazhuang, Hebei, China
RECRUITINGThe First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China
RECRUITINGThe First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
RECRUITINGRenmin Hospital of Wuhan University
Wuhan, Hubei, China
RECRUITING...and 18 more locations
Time frame: Week1 to Week12.
Terminal rate constant (λz)
To evaluate PK of ISM5411 in moderately to severely active UC patients.
Time frame: Week1 to Week12.
Elimination half-life (t1/2)
To evaluate PK of ISM5411 in moderately to severely active UC patients.
Time frame: Week1 to Week12.
Apparent volume of distribution (Vz/F)
To evaluate PK of ISM5411 in moderately to severely active UC patients.
Time frame: Week1 to Week12.
Apparent clearance (CL/F)
To evaluate PK of ISM5411 in moderately to severely active UC patients.
Time frame: Week1 to Week12.
Mean residence time (MRT)
To evaluate PK of ISM5411 in moderately to severely active UC patients.
Time frame: Week1 to Week12.
Colonic tissue concentration (Ccolon)
To evaluate PK of ISM5411 in moderately to severely active UC patients.
Time frame: Week1 to Week12.