A Single Dose Study of SHR0410 in Healthy Male Participants

Atridia

Status and phase: Completed; Phase 1

Conditions: Acute Pain

Treatments: Drug: 5μg/kg SHR0410; Drug: 0.5μg/kg SHR0410; Drug: 2μg/kg SHR0410; Drug: 20μg/kg SHR0410; Drug: 10μg/kg SHR0410; Drug: 1μg/kg SHR0410

Study type: Interventional

Funder types: Industry

Identifiers

NCT03493191

SHR0410-101-AU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 6 patient groups

0.5 μg/kg SHR0410

Experimental group

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)

Treatment:

Drug: 0.5μg/kg SHR0410

1 μg/kg SHR0410

Experimental group

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)

Treatment:

Drug: 1μg/kg SHR0410

2 μg/kg SHR0410

Experimental group

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)

Treatment:

Drug: 2μg/kg SHR0410

5 μg/kg SHR0410

Experimental group

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)

Treatment:

Drug: 5μg/kg SHR0410

10 μg/kg SHR0410

Experimental group

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)

Treatment:

Drug: 10μg/kg SHR0410

20 μg/kg SHR0410

Experimental group

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)

Treatment:

Drug: 20μg/kg SHR0410