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

Single-center, Randomized, Double-blind, Placebo-controlled, Single Dose Ascending Trial of SYHA1402 Tablets in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Neuropathy Peripheral
• Intervention / Treatment: Drug: 25mg; Drug: 50mg; Drug: 100mg; Drug: 200mg; Drug: 400mg; Drug: 800mg

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • The General Hospital of the People's Liberation Army

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of systolic blood pressure and diastolic blood pressure	To assess the change of blood pressure after administration of SYHA1402	0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours
Change of heart rate	To assess the change of heart rate after administration of SYHA1402	0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours
Change of pulse	To assess pulse after administration of SYHA1402	0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours
Change of body temperature	To assess the change of body temperature after administration of SYHA1402	0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours
Change of 12-lead ECG	To assess the change of 12-lead ECG (PR，QRS，QT，QTc) after administration of SYHA1402	0, 0.5, 1, 2, 4, 8, 24, 48, 72 hours
Change of physical examination	To assess the change of physical examination (including cardiovascular system, chest and lung, abdomen, nervous system, skeletal muscle system, etc) after administration of SYHA1402	24, 48, 72 hours
Change of blood biochemistry	To assess the change of blood biochemistry (including LDL, HDL,TC, ALT, AST, etc) after administration of SYHA1402	24, 48, 72 hours
Chagne of blood routine	To assess the change of blood routine after administration of SYHA1402	24, 48, 72 hours
Change of urinary routine	To assess the change of urinary routine after administration of SYHA1402	24, 48, 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak concentration (Cmax)	Plasma peak concentration (Cmax) after administration 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
Peak time (Tmax)	Plasma peak time (Tmax) after administration 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
Area under the plasma concentration-time curve (AUC0-72h)	The area under the plasma concentration-time curve of SYHA1402 after administration are calculated.	10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours
Half time (t1/2)	The half time of SYHA1402 after administration are calculated.	10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours
Apparent clearance (CL/F)	To assess the apparent clearance (CL/F) after administration 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
Proportional dose-response relationship between pharmacokinetic parameters Cmax and AUC of SYHA1402	To assess the 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

Collaborators and Investigators

• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2019
• Primary Completion (Actual): January 14, 2020
• Study Completion (Actual): January 14, 2020

Study Registration Dates

• First Submitted: June 10, 2019
• First Submitted That Met QC Criteria: June 13, 2019
• First Posted (Actual): June 17, 2019

Study Record Updates

• Last Update Posted (Actual): April 30, 2020
• Last Update Submitted That Met QC Criteria: April 28, 2020
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetic Neuropathies
• Other Study ID Numbers: SYHA1402201801/PRO-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No