Clinical trial NCT03988413: Study on Safety, Absorption and Metabolism of SYHA1402 Tablets in Healthy People
Official title: Single-center, Randomized, Double-blind, Placebo-controlled, Single Dose Ascending Trial of SYHA1402 Tablets in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetic Neuropathy Peripheral
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-06-17
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The trial used single-center, randomized, double-blind, placebo-controlled, single-dose study.

The trial planned to enroll sixty-two healthy volunteers. The subjects were allocated to seven dose groups, including 25 mg (4+2), 50 mg (8+2), 100 mg (8+2), 200 mg (8+2), 400 mg (8+2), 800 mg (6+2) and 1200 mg (6+2). Each dose group was allocated test drugs and placebos according to the proportion of subjects in the brackets mentioned above.


Eligibility criteria: Inclusion Criteria:

1. 18≤Age≤45, male or female;
2. Body weight (\> 45.0 kg (female) or 50.0 kg (male), 19.0 kg/m2 (\< BMI) = 26.0 kg/m2);
3. Subjects with normal clinical significance by medical history, vital signs, physical examination and laboratory examination;
4. All subjects who adopt effective non-hormonal contraceptive measures (such as condoms, intrauterine devices without drugs, etc.) from the signing of informed consent to three months after the end of the study;
5. Subjects who voluntarily signed the informed consent and are able to cooperate to complete the test according to the protocal.

Exclusion Criteria:

1. Female subjects: pregnant or lactating, or planned pregnancy; male subjects: their partner planned pregnancy, or planned to donate sperm;
2. Have neurological or psychiatric diseases history, or have serious cardiovascular, liver and kidney, endocrine, respiratory, blood, digestive, immune and other systemic diseases history;
3. Surgery history within six months before signing the informed consent;
4. Allergic history to more than one drug or other serious allergic rhistory.
5. Subjects with a QTc interval greater than 450 ms (male) or 470 MS (female), or with a history of prolonged QTc interval;
6. Positive with serum immunological test for HBsAg, Anti-HCV, Anti-HIV or Anti-TP;
7. History of drugs or drug abuse or alcoholics;
8. History of blood donation more than 200 mL within 8 weeks before signing informed consent;
9. Subjects participating in other clinical trials, or who have participated in any other clinical trials of drugs within three months before signing informed consent;
10. Not suitable for this trial according to the investigator.

Primary outcomes:
measure: Change of systolic blood pressure and diastolic blood pressure
timeFrame: 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours
measure: Change of heart rate
timeFrame: 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours
measure: Change of pulse
timeFrame: 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours
measure: Change of body temperature
timeFrame: 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours
measure: Change of 12-lead ECG
timeFrame: 0, 0.5, 1, 2, 4, 8, 24, 48, 72 hours
measure: Change of physical examination
timeFrame: 24, 48, 72 hours
measure: Change of blood biochemistry
timeFrame: 24, 48, 72 hours
measure: Chagne of blood routine
timeFrame: 24, 48, 72 hours
measure: Change of urinary routine
timeFrame: 24, 48, 72 hours
Secondary outcomes:
measure: Peak concentration (Cmax)
timeFrame: 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours
measure: Peak time (Tmax)
timeFrame: 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours
measure: Area under the plasma concentration-time curve (AUC0-72h)
timeFrame: 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours
measure: Half time (t1/2)
timeFrame: 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours
measure: Apparent clearance (CL/F)
timeFrame: 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours
measure: Proportional dose-response relationship between pharmacokinetic parameters Cmax and AUC of SYHA1402
timeFrame: 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours
Other outcomes:
Locations:
city: Beijing
country: China
facility: The General Hospital of the People's Liberation Army
Study officials:
References: