Back to resultsA Single Dose Study of SHR0410 in Healthy Male Participants
Primary Purpose
Acute Pain
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
0.5μg/kg SHR0410
1μg/kg SHR0410
2μg/kg SHR0410
5μg/kg SHR0410
10μg/kg SHR0410
20μg/kg SHR0410
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain
Eligibility Criteria
Inclusion Criteria:
- Male between the ages of 18 and 45 years, inclusive.
- Body mass index (BMI) of 18.0 to 30.0 kg/m2 and a total body weight of 50 kg to 125kg, inclusive.
- Considered generally healthy upon completion of medical history, physical examination, vital signs, SpO2, laboratory parameters, and ECG, as judged by the Investigator.
Exclusion Criteria:
- Known sensitivity to any of the components of the investigational product formulation, or any other opioids.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Any other medical or psychological condition, which in the opinion of the Investigator, might create undue risk to the participant or interfere with the participant's ability to comply with the protocol requirements, or to complete the study.
Sites / Locations
- Linear Clinical Research Limited
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
0.5 μg/kg SHR0410
1 μg/kg SHR0410
2 μg/kg SHR0410
5 μg/kg SHR0410
10 μg/kg SHR0410
20 μg/kg SHR0410
Arm Description
8 subjects will be randomized in a 3:1 ratio to receive a single dose of either 0.5μg/kg SHR0410 (n=6) or placebo (n=2)
8 subjects will be randomized in a 3:1 ratio to receive a single dose of either 1μg/kg SHR0410 (n=6) or placebo (n=2)
8 subjects will be randomized in a 3:1 ratio to receive a single dose of either 2μg/kg SHR0410 (n=6) or placebo (n=2)
8 subjects will be randomized in a 3:1 ratio to receive a single dose of either 5μg/kg SHR0410 (n=6) or placebo (n=2)
8 subjects will be randomized in a 3:1 ratio to receive a single dose of either 10μg/kg SHR0410 (n=6) or placebo (n=2)
8 subjects will be randomized in a 3:1 ratio to receive a single dose of either 10μg/kg SHR0410 (n=6) or placebo (n=2)
Outcomes
Primary Outcome Measures
Incidence of Adverse events in terms of changes in Hematology
Hemoglobin Hematocrit Erythrocytes count Mean cell volume, Mean cell hemoglobin concentration, Leukocytes count, Neutrophils count, Lymphocytes count, Monocytes count, Eosinophils count, Basophils count, Platelets count
Incidence of Adverse events in terms of changes in Urinalysis
Urobilinogen Dipstick urinalysis, including: pH, Specific gravity, Protein, Blood, Leukocytes, Glucose, Ketones, Bilirubin, Nitrites
Incidence of Adverse events in terms of changes in Biochemistry (fasting)
Including Serum creatinine, Urea, Alanine aminotransferase, Aspartate aminotransferase, Gamma glutamyl transferase, Total bilirubin, Total protein, Albumin, Alkaline phosphatase, Serum uric acid, Glucose, Triglycerides, Total cholesterol, High-density lipoprotein cholesterol, Low-density lipoprotein cholesterol
Incidence of Adverse events in terms of changes in Physical examinations
Review of body weight and height; general appearance; head; eyes; ears/nose/throat; neck; lymph nodes; neurological and musculoskeletal systems; heart; lungs; abdomen; skin; and extremities
Incidence of Adverse events in terms of changes in Vital signs
Oral temperature, respiratory rate, blood pressure, and pulse rate
Incidence of Adverse events in terms of changes in 12-lead ECGs
The 12-lead ECGs must be recorded after the subjects have rested in the supine position for 5 minutes to ensure a stable baseline.
Secondary Outcome Measures
Area under the plasma concentration versus time curve (AUC)
Plasma SHR0410 Area Under the Concentration-time Curve (AUC)
Time to the peak plasma concentration (Tmax)
Time to Maximum Plasma SHR0410 Concentration
Peak Plasma Concentration (Cmax)
Peak Plasma SHR0410 Concentration
Half-time (T1/2)
Half-time of SHR0410
Urine output rate
Changes in urine output rate from baseline
Serum prolactin release rate
Changes in serum prolactin release rate from baseline
Full Information
NCT ID
NCT03493191
First Posted
March 26, 2018
Last Updated
February 25, 2019
Sponsor
Atridia Pty Ltd.
Collaborators
Linear Clinical Research
1. Study Identification
Unique Protocol Identification Number
NCT03493191
Brief Title
A Single Dose Study of SHR0410 in Healthy Male Participants
Official Title
A Phase I, Randomized, Double-blind, Placebo-Controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous SHR0410 in Healthy Male Participants
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 15, 2018 (Actual)
Primary Completion Date
June 29, 2018 (Actual)
Study Completion Date
July 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atridia Pty Ltd.
Collaborators
Linear Clinical Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a randomized, double-blind, placebo-controlled, single ascending-dose study to investigate the effect of a single intravenous (IV) dose of SHR0410 at 6 dose levels (0.5 μg/kg, 1 μg/kg, 2 μg/kg, 5 μg/kg, 10 μg/kg and 20 μg/kg) in healthy participants.
Detailed Description
Forty eight eligible participants will be enrolled into the 6 dose cohorts. For each cohort, a sentinel group of 2 subjects (1 receiving SHR0410 and 1 receiving placebo) will be dosed first (1:1 ratio). If no drug related adverse events occur in the sentinel participants, the remaining 6 subjects in a cohort will be dosed on the next day or later in a 5:1 ratio (5 subjects receiving SHR0410 and 1 subject receiving placebo). SHR0410 will be diluted in saline and administered as a 15 min constant dose IV infusion at a rate of 20 ml/hr on Day 1.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.5 μg/kg SHR0410
Arm Type
Experimental
Arm Description
8 subjects will be randomized in a 3:1 ratio to receive a single dose of either 0.5μg/kg SHR0410 (n=6) or placebo (n=2)
Arm Title
1 μg/kg SHR0410
Arm Type
Experimental
Arm Description
8 subjects will be randomized in a 3:1 ratio to receive a single dose of either 1μg/kg SHR0410 (n=6) or placebo (n=2)
Arm Title
2 μg/kg SHR0410
Arm Type
Experimental
Arm Description
8 subjects will be randomized in a 3:1 ratio to receive a single dose of either 2μg/kg SHR0410 (n=6) or placebo (n=2)
Arm Title
5 μg/kg SHR0410
Arm Type
Experimental
Arm Description
8 subjects will be randomized in a 3:1 ratio to receive a single dose of either 5μg/kg SHR0410 (n=6) or placebo (n=2)
Arm Title
10 μg/kg SHR0410
Arm Type
Experimental
Arm Description
8 subjects will be randomized in a 3:1 ratio to receive a single dose of either 10μg/kg SHR0410 (n=6) or placebo (n=2)
Arm Title
20 μg/kg SHR0410
Arm Type
Experimental
Arm Description
8 subjects will be randomized in a 3:1 ratio to receive a single dose of either 10μg/kg SHR0410 (n=6) or placebo (n=2)
Intervention Type
Drug
Intervention Name(s)
0.5μg/kg SHR0410
Intervention Description
a single dose of 0.5μg/kg SHR0410
Intervention Type
Drug
Intervention Name(s)
1μg/kg SHR0410
Intervention Description
a single dose of 2μg/kg SHR0410
Intervention Type
Drug
Intervention Name(s)
2μg/kg SHR0410
Intervention Description
a single dose of 2μg/kg SHR0410
Intervention Type
Drug
Intervention Name(s)
5μg/kg SHR0410
Intervention Description
a single dose of 5μg/kg SHR0410
Intervention Type
Drug
Intervention Name(s)
10μg/kg SHR0410
Intervention Description
a single dose of 10μg/kg SHR0410
Intervention Type
Drug
Intervention Name(s)
20μg/kg SHR0410
Intervention Description
a single dose of 20μg/kg SHR0410
Primary Outcome Measure Information:
Title
Incidence of Adverse events in terms of changes in Hematology
Description
Hemoglobin Hematocrit Erythrocytes count Mean cell volume, Mean cell hemoglobin concentration, Leukocytes count, Neutrophils count, Lymphocytes count, Monocytes count, Eosinophils count, Basophils count, Platelets count
Time Frame
Up to Day 8
Title
Incidence of Adverse events in terms of changes in Urinalysis
Description
Urobilinogen Dipstick urinalysis, including: pH, Specific gravity, Protein, Blood, Leukocytes, Glucose, Ketones, Bilirubin, Nitrites
Time Frame
Up to Day 8
Title
Incidence of Adverse events in terms of changes in Biochemistry (fasting)
Description
Including Serum creatinine, Urea, Alanine aminotransferase, Aspartate aminotransferase, Gamma glutamyl transferase, Total bilirubin, Total protein, Albumin, Alkaline phosphatase, Serum uric acid, Glucose, Triglycerides, Total cholesterol, High-density lipoprotein cholesterol, Low-density lipoprotein cholesterol
Time Frame
Up to Day 8
Title
Incidence of Adverse events in terms of changes in Physical examinations
Description
Review of body weight and height; general appearance; head; eyes; ears/nose/throat; neck; lymph nodes; neurological and musculoskeletal systems; heart; lungs; abdomen; skin; and extremities
Time Frame
Up to Day 8
Title
Incidence of Adverse events in terms of changes in Vital signs
Description
Oral temperature, respiratory rate, blood pressure, and pulse rate
Time Frame
Up to Day 8
Title
Incidence of Adverse events in terms of changes in 12-lead ECGs
Description
The 12-lead ECGs must be recorded after the subjects have rested in the supine position for 5 minutes to ensure a stable baseline.
Time Frame
Up to Day 8
Secondary Outcome Measure Information:
Title
Area under the plasma concentration versus time curve (AUC)
Description
Plasma SHR0410 Area Under the Concentration-time Curve (AUC)
Time Frame
Up to 24 hours post dose
Title
Time to the peak plasma concentration (Tmax)
Description
Time to Maximum Plasma SHR0410 Concentration
Time Frame
Up to 24 hours post dose
Title
Peak Plasma Concentration (Cmax)
Description
Peak Plasma SHR0410 Concentration
Time Frame
Up to 24 hours post dose
Title
Half-time (T1/2)
Description
Half-time of SHR0410
Time Frame
Up to 24 hours post dose
Title
Urine output rate
Description
Changes in urine output rate from baseline
Time Frame
Up to 48 hours post dose
Title
Serum prolactin release rate
Description
Changes in serum prolactin release rate from baseline
Time Frame
Up to 48 hours post dose
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male between the ages of 18 and 45 years, inclusive.
Body mass index (BMI) of 18.0 to 30.0 kg/m2 and a total body weight of 50 kg to 125kg, inclusive.
Considered generally healthy upon completion of medical history, physical examination, vital signs, SpO2, laboratory parameters, and ECG, as judged by the Investigator.
Exclusion Criteria:
Known sensitivity to any of the components of the investigational product formulation, or any other opioids.
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
Any other medical or psychological condition, which in the opinion of the Investigator, might create undue risk to the participant or interfere with the participant's ability to comply with the protocol requirements, or to complete the study.
Facility Information:
Facility Name
Linear Clinical Research Limited
City
Nedlands
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
A Single Dose Study of SHR0410 in Healthy Male Participants
We'll reach out to this number within 24 hrs