A Phase I Study of Etrasimod in Healthy Chinese Audlt Subjects.

Healthy Volunteers Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Phase I Study in Healthy Chinese Adult Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Characteristics of Etrasimod Following Oral Single and Multiple Doses Administration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03894163
• Other study ID #: ES101001
• Status: Recruiting
• Phase: Phase 1
• Start date: February 22, 2019
• Est. completion date: October 31, 2019

Study information

• Verified date: March 2019
• Source: Everstar Therapeutics Limited
• Contact: Haiyan Li, Director
• Phone: +86 10 8226 5509
• Email: haiyanli1027[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of the trial is to assess the safety and tolerability of Etrasimod after single and multiple oral doses administration in healthy Chinese adult subjects.

The Secondary Objective of the trial is to assess PK characteristics of Etrasimod and its metabolites(M3 and M6)after single and multiple oral doses administration in healthy Chinese adult subjects; To assess PD characteristics of Etrasimod after single and multiple oral doses administration in healthy Chinese adult subjects.

Description:

There are 3 dose cohorts (1 mg, 2 mg, and 3 mg) in this study. Each dose cohort is planned to enroll 12 subjects randomized to receive Etrasimod or placebo (9 for Etrasimod, 3 for placebo), for a total of 36 subjects are planned in the study. Etrasimod will be administered at doses of 1 mg, 2 mg, and 3 mg in cohort 1, 2, and 3, respectively.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: October 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Healthy male or female of Chinese-ethic origin, 18~45 years of age (both inclusive; according to the time of signing inform consent form);

2. Able to give signed written informed consent form voluntarily;

3. Agree to remain hospitalized in clinic for the study duration without interruption;

4. Body weight = 50 kg and body mass index (BMI, weight [kg]/height2 [m]2) within 19.0-24.0 kg/m2 (both inclusive);

5. Blood Pressure (BP) at screening: systolic blood pressure (SBP) = 90mmHg and <140mmHg, and diastolic blood pressure (DBP) = 50mmHg and <90mmHg;

6. 12-lead electrocardiogram (ECG) showing no clinically significant abnormalities;

7. No any clinically significant abnormal values on physical examination, clinical laboratory test, liver function or kidney function, and other required test.

Exclusion Criteria:

1. History of severe drug (e.g. or asthma induced by asprin) or excipient allergy, or hypersensitivity to Etrasimod tablets or other S1P receptor modulators;

2. Subjects with researcher considered clinically significant major illness (cardiovascular, cerebrovascular, digestive systems, respiratory systems, or endocrine systems diseases, etc.) or surgery (except for minor outpatient surgery) within past 3 months prior to screening, or planed surgery during study;

3. Symptoms or illness compatible with gastrointestinal or respiratory viral syndrome within 2 weeks prior to screening;

4. Subjects with intolerance to venous blood collection;

5. Subjects with a history of hypothyroidism and/or thyroiditis;

6. Subject who is considered unsuitable for participating in the study in the opinion of investigator.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Etrasimod
Etrasimod Tablet
• Etrasimod Placebo
Etrasimod Placebo tablet

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Everstar Therapeutics Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety for adverse events (AE) for Cardiac function, lung function, liver function and Ophthalmologic examination.	number of adverse events (AE) as assessed by CTCAE v5.0	from screening to study completion, up to 45 days.
Primary	safety for laboratory parameters of Hematology, Biochemistry, Urinalysis, Coagulation, Thyroid Function and Virology.	Clinical laboratory tests (hematology, clinical chemistry, urinalysis, coagulation)	from screening to study completion, up to 45 days.
Primary	safety for physical examination including Ophthalmologic examination and Pulmonary function test.	Physical examination including full physical examination, ophthalmologic examination and Pulmonary function test.	from screening to study completion, up to 45 days.
Secondary	Cmax	Cmax	Day1,Day15,Day16,Day17~Day23
Secondary	Tmax	Tmax	Day1,Day15,Day16,Day17~Day23
Secondary	t1/2	t1/2	Day1,Day15,Day16,Day17~Day23
Secondary	AUC0-t	AUC0-t	Day1,Day15,Day16,Day17~Day23
Secondary	AUC0-inf	AUC0-inf	Day1,Day15,Day16,Day17~Day23
Secondary	ALC	ALC	Day1~Day9, Day11,Day13,Day15,Day17,Day19,Day24