A Single-dose, Dose-escalation Study of a Long-acting MOD-6031 in Healthy Overweight or Obese Subjects

A Phase I, Randomized, Single-Blinded, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of MOD-6031 in Healthy Volunteers

MOD-6031 is a long-acting reversibly PEGylated oxyntomodulin (OXM) therapeutic. The active moiety is a gastrointestinal neuropeptide with a sequence identical to endogenous human OXM and is an agonist for both glucagon-like peptide-1 (GLP1) and glucagon (GCG) receptors. The peptide is a natural appetite suppressant, secreted by L-cells in the digestive system following food intake leading to a decrease in gastric emptying, satiety after crossing the blood-brain barrier, and regulation of insulin and glucose levels. Thus, MOD-6031 is being developed as a treatment for high risk subjects (obese) to increase weight loss, reduce food intake and increase glycemic control.

This will be a a randomized, single-blind, placebo-controlled, single-dose, dose-escalation study. Five escalating dose groups are planned, with 8 subjects per dose group, randomized in 3:1 ratio to receive a single dose of MOD-6031 or matching Placebo (6 MOD-6031 to 2 placebo subjects). The initial MOD-6031 dose will be 20 mg, followed by single doses of 50 mg, 100 mg, 150 mg and 200 mg. Each subject will receive a single study drug injection in the morning (dosing day designated as Day 0) and will be monitored for 30 days.

Inclusion Criteria:

• Healthy male, between 18 to 55 years of age.
• BMI 27-35 Kg/m2 (inclusive).
• Generally good health.
• Triglyceride ≤ 400mg/ml
• ECG with no clinically significant abnormalities.
• Negative HIV, hepatitis B or hepatitis C serology tests at screening
• No significant abnormalities in clinical laboratory parameters
• No history of alcohol or drug abuse.

Exclusion Criteria:

• History of clinically significant medical condition.
• Any cardiac conduction defect.
• Any acute or unstable disease.
• History of malignancy diagnosed within the past 5 years.
• Known or suspected diabetes and/or HbA1C >6.4% on screening.
• Known allergy to any drug.
• Treatment with weight loss drugs (within 3 months prior to dosing).
• Liposuction or other surgery for weight loss within the last year.
• Evidence of eating disorders (bulimia, binge eating).
• History of regular alcohol consumption exceeding.
• Use of tobacco or nicotine-containing products.
• Subjects that have difficulty fasting or consuming the standard meals that will be provided.