NCT03988413

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2019

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 17, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

August 5, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2020

Completed
Last Updated

April 30, 2020

Status Verified

June 1, 2019

Enrollment Period

5 months

First QC Date

June 10, 2019

Last Update Submit

April 28, 2020

Conditions

Diabetic Neuropathy Peripheral

Outcome Measures

Primary Outcomes (9)

  • 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 Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • +1 more secondary outcomes

Study Arms (6)

25mg

EXPERIMENTAL

Tablets, Oral, 25mg, single dose

Drug: 25mg

50mg

EXPERIMENTAL

Tablets, Oral, 50mg, single dose

Drug: 50mg

100mg

EXPERIMENTAL

Tablets, Oral, 100mg, single dose

Drug: 100mg

200mg

EXPERIMENTAL

Tablets, Oral, 200mg, single dose

Drug: 200mg

400mg

EXPERIMENTAL

Tablets, Oral, 400mg, single dose

Drug: 400mg

800mg

EXPERIMENTAL

Tablets, Oral, 800mg, single dose

Drug: 800mg

Interventions

25mgDRUG

SYHA1402 25mg or Placebo 25mg

25mg
50mgDRUG

SYHA1402 50mg or Placebo 50mg

50mg
100mgDRUG

SYHA1402 100mg or Placebo 100mg

100mg
200mgDRUG

SYHA1402 200mg or Placebo 200mg

200mg
400mgDRUG

SYHA1402 400mg or Placebo 400mg

400mg
800mgDRUG

SYHA1402 800mg or Placebo 800mg

800mg

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ≤Age≤45, male or female;
  • Body weight (\> 45.0 kg (female) or 50.0 kg (male), 19.0 kg/m2 (\< BMI) = 26.0 kg/m2);
  • Subjects with normal clinical significance by medical history, vital signs, physical examination and laboratory examination;
  • 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;
  • Subjects who voluntarily signed the informed consent and are able to cooperate to complete the test according to the protocal.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The General Hospital of the People's Liberation Army

Beijing, China

Location

Related Publications (1)

  • Liang B, Wang J, Zhang G, Wang R, Cai Y. Safety, Tolerability and Pharmacokinetics of Single-Dose Oral SYHA1402 in Healthy Chinese Subjects. Neurol Ther. 2023 Jun;12(3):947-959. doi: 10.1007/s40120-023-00480-x. Epub 2023 Apr 24.

    PMID: 37093466DERIVED

MeSH Terms

Interventions

Magnesium-25

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2019

First Posted

June 17, 2019

Study Start

August 5, 2019

Primary Completion

January 14, 2020

Study Completion

January 14, 2020

Last Updated

April 30, 2020

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)