A Single Dose Study of SHR0410 in Healthy Male Participants

NCT03493191 | Completed Phase 1

• 1 other identifier: SHR0410-101-AU
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• Incidence of Adverse events in terms of changes in Vital signs

  Oral temperature, respiratory rate, blood pressure, and pulse rate

  Up to Day 8

• 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 Outcomes (6)

• Area under the plasma concentration versus time curve (AUC)

  Up to 24 hours post dose

• Time to the peak plasma concentration (Tmax)

  Up to 24 hours post dose

• Peak Plasma Concentration (Cmax)

  Up to 24 hours post dose

• Half-time (T1/2)

  Up to 24 hours post dose

• Urine output rate

  Up to 48 hours post dose

Study Arms (6)

0.5 μg/kg SHR0410

EXPERIMENTAL

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)

Drug: 0.5μg/kg SHR0410

1 μg/kg SHR0410

EXPERIMENTAL

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)

Drug: 1μg/kg SHR0410

2 μg/kg SHR0410

EXPERIMENTAL

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)

Drug: 2μg/kg SHR0410

5 μg/kg SHR0410

EXPERIMENTAL

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)

Drug: 5μg/kg SHR0410

10 μg/kg SHR0410

EXPERIMENTAL

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)

Drug: 10μg/kg SHR0410

20 μg/kg SHR0410

EXPERIMENTAL

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)

Drug: 20μg/kg SHR0410

Interventions

0.5μg/kg SHR0410 DRUG

a single dose of 0.5μg/kg SHR0410

0.5 μg/kg SHR0410

1μg/kg SHR0410 DRUG

a single dose of 2μg/kg SHR0410

1 μg/kg SHR0410

2μg/kg SHR0410 DRUG

a single dose of 2μg/kg SHR0410

2 μg/kg SHR0410

5μg/kg SHR0410 DRUG

a single dose of 5μg/kg SHR0410

5 μg/kg SHR0410

10μg/kg SHR0410 DRUG

a single dose of 10μg/kg SHR0410

10 μg/kg SHR0410

20μg/kg SHR0410 DRUG

a single dose of 20μg/kg SHR0410

20 μg/kg SHR0410

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Atridia Pty Ltd.: lead
• Linear Clinical Research: collaborator

Study Sites (1)

Linear Clinical Research Limited

Nedlands, Australia

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 10, 2018
• Study Start: April 15, 2018
• Primary Completion: June 29, 2018
• Study Completion: July 14, 2018
• Last Updated: February 26, 2019

Record last verified: 2018-05

Locations

AU (1)