Acute PainPhase 1NCT03493191
A Single Dose Study of SHR0410 in Healthy Male Participants
A Phase 1 study testing 0.5μg/kg SHR0410, 1μg/kg SHR0410 and 2μg/kg SHR0410 in people with Acute Pain, run by Atridia Pty Ltd. at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Acute Pain
- What is being tested?
- 0.5μg/kg SHR0410, 1μg/kg SHR0410 and 2μg/kg SHR0410
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Apr 2018to 14 Jul 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Acute Pain
- Being tested
- 0.5μg/kg SHR0410, 1μg/kg SHR0410, 2μg/kg SHR0410, 5μg/kg SHR0410, 10μg/kg SHR0410
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5μg/kg SHR0410Drug
a single dose of 0.5μg/kg SHR0410
1μg/kg SHR0410Drug
a single dose of 2μg/kg SHR0410
2μg/kg SHR0410Drug
a single dose of 2μg/kg SHR0410
5μg/kg SHR0410Drug
a single dose of 5μg/kg SHR0410
10μg/kg SHR0410Drug
a single dose of 10μg/kg SHR0410
20μg/kg SHR0410Drug
a single dose of 20μg/kg SHR0410
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: Drug: 20μg/kg SHR0410 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to Day 8
Incidence of Adverse events in terms of changes in Vital signs
Oral temperature, respiratory rate, blood pressure, and pulse rate
Measured: 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.
Measured: Up to Day 8
Secondary outcomes (6)
Area under the plasma concentration versus time curve (AUC)
Plasma SHR0410 Area Under the Concentration-time Curve (AUC)
Measured: Up to 24 hours post dose
Time to the peak plasma concentration (Tmax)
Time to Maximum Plasma SHR0410 Concentration
Measured: Up to 24 hours post dose
Peak Plasma Concentration (Cmax)
Peak Plasma SHR0410 Concentration
Measured: Up to 24 hours post dose
Half-time (T1/2)
Half-time of SHR0410
Measured: Up to 24 hours post dose
Urine output rate
Changes in urine output rate from baseline
Measured: Up to 48 hours post dose
Serum prolactin release rate
Changes in serum prolactin release rate from baseline
Measured: Up to 48 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start15 Apr 2018
- Primary completion29 Jun 2018
- Study completion14 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atridia Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Linear Clinical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493191
- Sponsor's protocol ID
- SHR0410-101-AU
- Status last verified
- May 2018
- First submitted
- 26 Mar 2018
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03493191
- Acronym / sponsor ID
- SHR0410-101-AU
- Conditions
- Acute Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Atridia Pty Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Linear Clinical Research
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 29 Jun 2018 (actual)
- Study completion
- 14 Jul 2018 (actual)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 0.5 μg/kg SHR0410 | Experimental | Drug: 0.5μg/kg SHR04108 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) |
| 1 μg/kg SHR0410 | Experimental | Drug: 1μg/kg SHR04108 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) |
| 2 μg/kg SHR0410 | Experimental | Drug: 2μg/kg SHR04108 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) |
| 5 μg/kg SHR0410 | Experimental | Drug: 5μg/kg SHR04108 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) |
| 10 μg/kg SHR0410 | Experimental | Drug: 10μg/kg SHR04108 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) |
| 20 μg/kg SHR0410 | Experimental | Drug: 20μg/kg SHR04108 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) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.5μg/kg SHR0410a single dose of 0.5μg/kg SHR0410 | Drug | 0.5 μg/kg SHR0410 |
| 1μg/kg SHR0410a single dose of 2μg/kg SHR0410 | Drug | 1 μg/kg SHR0410 |
| 2μg/kg SHR0410a single dose of 2μg/kg SHR0410 | Drug | 2 μg/kg SHR0410 |
| 5μg/kg SHR0410a single dose of 5μg/kg SHR0410 | Drug | 5 μg/kg SHR0410 |
| 10μg/kg SHR0410a single dose of 10μg/kg SHR0410 | Drug | 10 μg/kg SHR0410 |
| 20μg/kg SHR0410a single dose of 20μg/kg SHR0410 | Drug | 20 μg/kg SHR0410 |
Primary outcome
Incidence of Adverse events in terms of changes in Hematology
Time frame: Up to Day 8
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
Time frame: Up to Day 8
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)
Time frame: Up to Day 8
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
Time frame: Up to Day 8
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
Time frame: Up to Day 8
Oral temperature, respiratory rate, blood pressure, and pulse rate
Incidence of Adverse events in terms of changes in 12-lead ECGs
Time frame: Up to Day 8
The 12-lead ECGs must be recorded after the subjects have rested in the supine position for 5 minutes to ensure a stable baseline.
6 secondary outcomes
Area under the plasma concentration versus time curve (AUC)
Time frame: Up to 24 hours post dose
Time to the peak plasma concentration (Tmax)
Time frame: Up to 24 hours post dose
Peak Plasma Concentration (Cmax)
Time frame: Up to 24 hours post dose
Half-time (T1/2)
Time frame: Up to 24 hours post dose
Urine output rate
Time frame: Up to 48 hours post dose
Serum prolactin release rate
Time frame: Up to 48 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 0.5μg/kg SHR0410, 1μg/kg SHR0410 and 2μg/kg SHR0410 in people with Acute Pain, run by Atridia Pty Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse events in terms of changes in Hematology (time frame: Up to Day 8). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.