Ascending single doses of a novel Interlukin (IL-1 ) agonist administered to healthy subjects.

Phase 1 Randomized, Double-Blind, Placebo-Controlled Trial in Healthy Male Volunteers To Examine The Safety, Tolerability, And Pharmacokinetics Of HMPL-011 After A Single Dose

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000891224

Enrollment

Registered

2009-10-12

Start date

2009-10-19

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Ascending single doses of a novel IL-10 agonist administered to healthy subjects. In the single ascending dose 8 subjects, will receive single oral dose of test medication (or placebo ) in a double-blind manner. Doses will be: Cohort 1: 10 mg Cohort 2: 50 mg Cohort 3: 200 mg Cohort 4: 400 mg Cohort 5: 800 mg The duration of each cohort is 2 days postdose, with a single dose administered on Day 1.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

Male

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy male subjects having Body Mass Index(BMI) between 19 and 34 kg/m2

Exclusion criteria

Any significant acute or chronic medical conditions. Subjects at risk of tuberculosis(TB). Evidence of organ dysfunction or any clinically significant deviation from normal.

Outcome results