A Single Dose Study of SHR0410 in Healthy Male Participants

Acute Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03493191
• Other study ID #: SHR0410-101-AU
• Status: Completed
• Phase: Phase 1
• Start date: April 15, 2018
• Est. completion date: July 14, 2018

Study information

• Verified date: May 2018
• Source: Atridia Pty Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 14, 2018
• Est. primary completion date: June 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Male between the ages of 18 and 45 years, inclusive.

2. Body mass index (BMI) of 18.0 to 30.0 kg/m2 and a total body weight of 50 kg to 125kg, inclusive.

3. Considered generally healthy upon completion of medical history, physical examination, vital signs, SpO2, laboratory parameters, and ECG, as judged by the Investigator.

Exclusion Criteria:

1. Known sensitivity to any of the components of the investigational product formulation, or any other opioids.

2. 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).

3. 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.

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• 0.5µg/kg SHR0410
a single dose of 0.5µg/kg SHR0410
• 1µg/kg SHR0410
a single dose of 2µg/kg SHR0410
• 2µg/kg SHR0410
a single dose of 2µg/kg SHR0410
• 5µg/kg SHR0410
a single dose of 5µg/kg SHR0410
• 10µg/kg SHR0410
a single dose of 10µg/kg SHR0410
• 20µg/kg SHR0410
a single dose of 20µg/kg SHR0410

Locations

Country	Name	City	State
Australia	Linear Clinical Research Limited	Nedlands

Sponsors (2)

Lead Sponsor	Collaborator
Atridia Pty Ltd.	Linear Clinical Research

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to Day 8
Primary	Incidence of Adverse events in terms of changes in Urinalysis	Urobilinogen Dipstick urinalysis, including: pH, Specific gravity, Protein, Blood, Leukocytes, Glucose, Ketones, Bilirubin, Nitrites	Up to Day 8
Primary	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	Up to Day 8
Primary	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	Up to Day 8
Primary	Incidence of Adverse events in terms of changes in Vital signs	Oral temperature, respiratory rate, blood pressure, and pulse rate	Up to Day 8
Primary	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.	Up to Day 8
Secondary	Area under the plasma concentration versus time curve (AUC)	Plasma SHR0410 Area Under the Concentration-time Curve (AUC)	Up to 24 hours post dose
Secondary	Time to the peak plasma concentration (Tmax)	Time to Maximum Plasma SHR0410 Concentration	Up to 24 hours post dose
Secondary	Peak Plasma Concentration (Cmax)	Peak Plasma SHR0410 Concentration	Up to 24 hours post dose
Secondary	Half-time (T1/2)	Half-time of SHR0410	Up to 24 hours post dose
Secondary	Urine output rate	Changes in urine output rate from baseline	Up to 48 hours post dose
Secondary	Serum prolactin release rate	Changes in serum prolactin release rate from baseline	Up to 48 hours post dose