Clinical trial NCT03493191: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Pain
Lead sponsor: Atridia Pty Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Linear Clinical Research
First posted: 2018-04-10
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Adverse events in terms of changes in Hematology
timeFrame: Up to Day 8
measure: Incidence of Adverse events in terms of changes in Urinalysis
timeFrame: Up to Day 8
measure: Incidence of Adverse events in terms of changes in Biochemistry (fasting)
timeFrame: Up to Day 8
measure: Incidence of Adverse events in terms of changes in Physical examinations
timeFrame: Up to Day 8
measure: Incidence of Adverse events in terms of changes in Vital signs
timeFrame: Up to Day 8
measure: Incidence of Adverse events in terms of changes in 12-lead ECGs
timeFrame: Up to Day 8
Secondary outcomes:
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: Up to 24 hours post dose
measure: Time to the peak plasma concentration (Tmax)
timeFrame: Up to 24 hours post dose
measure: Peak Plasma Concentration (Cmax)
timeFrame: Up to 24 hours post dose
measure: Half-time (T1/2)
timeFrame: Up to 24 hours post dose
measure: Urine output rate
timeFrame: Up to 48 hours post dose
measure: Serum prolactin release rate
timeFrame: Up to 48 hours post dose
Other outcomes:
Locations:
city: Nedlands
country: Australia
facility: Linear Clinical Research Limited
Study officials:
References: