Study on Safety, Absorption and Metabolism of SYHA1402 Tablets in Healthy People

• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03988413
• Collaborator: (none)
• Enrollment: 54
• Location: 1
• Arms: 6
• Actual Duration (Months): 5.3
• Patients Per Site Per Month: 10.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Neuropathy Peripheral	Drug: 25mg; Drug: 50mg; Drug: 100mg; Drug: 200mg; Drug: 400mg; Drug: 800mg	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Single-center, Randomized, Double-blind, Placebo-controlled, Single Dose Ascending Trial of SYHA1402 Tablets in Healthy Subjects
• Actual Study Start Date: Aug 5, 2019
• Actual Primary Completion Date: Jan 14, 2020
• Actual Study Completion Date: Jan 14, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 25mg Tablets, Oral, 25mg, single dose	Drug: 25mg; SYHA1402 25mg or Placebo 25mg
Experimental: 50mg Tablets, Oral, 50mg, single dose	Drug: 50mg; SYHA1402 50mg or Placebo 50mg
Experimental: 100mg Tablets, Oral, 100mg, single dose	Drug: 100mg; SYHA1402 100mg or Placebo 100mg
Experimental: 200mg Tablets, Oral, 200mg, single dose	Drug: 200mg; SYHA1402 200mg or Placebo 200mg
Experimental: 400mg Tablets, Oral, 400mg, single dose	Drug: 400mg; SYHA1402 400mg or Placebo 400mg
Experimental: 800mg Tablets, Oral, 800mg, single dose	Drug: 800mg; SYHA1402 800mg or Placebo 800mg

Outcome Measures

Primary Outcome Measures

1. Change of systolic blood pressure and diastolic blood pressure [0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours]

   To assess the change of blood pressure after administration of SYHA1402

2. Change of heart rate [0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours]

   To assess the change of heart rate after administration of SYHA1402

3. Change of pulse [0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours]

   To assess pulse after administration of SYHA1402

4. Change of body temperature [0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours]

   To assess the change of body temperature after administration of SYHA1402

5. Change of 12-lead ECG [0, 0.5, 1, 2, 4, 8, 24, 48, 72 hours]

   To assess the change of 12-lead ECG (PR，QRS，QT，QTc) after administration of SYHA1402

6. Change of physical examination [24, 48, 72 hours]

   To assess the change of physical examination (including cardiovascular system, chest and lung, abdomen, nervous system, skeletal muscle system, etc) after administration of SYHA1402

7. Change of blood biochemistry [24, 48, 72 hours]

   To assess the change of blood biochemistry (including LDL, HDL,TC, ALT, AST, etc) after administration of SYHA1402

8. Chagne of blood routine [24, 48, 72 hours]

   To assess the change of blood routine after administration of SYHA1402

9. Change of urinary routine [24, 48, 72 hours]

   To assess the change of urinary routine after administration of SYHA1402

Secondary Outcome Measures

1. Peak concentration (Cmax) [10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours]

   Plasma peak concentration (Cmax) after administration of SYHA1402

2. Peak time (Tmax) [10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours]

   Plasma peak time (Tmax) after administration of SYHA1402

3. Area under the plasma concentration-time curve (AUC0-72h) [10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours]

   The area under the plasma concentration-time curve of SYHA1402 after administration are calculated.

4. Half time (t1/2) [10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours]

   The half time of SYHA1402 after administration are calculated.

5. Apparent clearance (CL/F) [10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours]

   To assess the apparent clearance (CL/F) after administration of SYHA1402

6. Proportional dose-response relationship between pharmacokinetic parameters Cmax and AUC of SYHA1402 [10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours]

   To assess the Proportional dose-response relationship between pharmacokinetic parameters Cmax and AUC of SYHA1402

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The General Hospital of the People's Liberation Army	Beijing		China

Sponsors and Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03988413
• Other Study ID Numbers: SYHA1402201801/PRO-1
• First Posted: Jun 17, 2019
• Last Update Posted: Apr 30, 2020
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetic Neuropathies; Peripheral Nervous System Diseases

Study Results

No Results Posted as of Apr 30, 2020