Safety Study of HPP593 in Subjects During and After Limb Immobilization

High Point Pharmaceuticals

Status and phase

Terminated

Phase 1

Conditions

Muscle Atrophy

Hypodynamia

Treatments

Drug: Placebo

Drug: HPP593

Study type

Interventional

Funder types

Industry

Identifiers

HPP593-103

Details and patient eligibility

About

This is a safety and tolerability study investigating the effect of HPP593 in healthy volunteers during and after limb immobilization.

Enrollment

24 patients

Sex

Male

Ages

30 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Non-smoking.
Subjects must be in good health, as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical test results.
Not restricted to a wheel-chair or confined to a bed.
Weight ≥ 50.0 kg.
BMI between 18 and 27.5 kg/m2, inclusive, at the time of screening.

Exclusion criteria

Any of the following abnormalities at Screening Visit and Baseline:
- Fasting glucose > 110 mg/dL (Screening visit only).
- Serum creatinine > 1.5 mg/dL. If serum creatinine is >1.5 mg/dL and creatinine clearance is >60 mL/min, the subject need not be excluded
- Troponin I level above the upper limit of normal (ULN)
- Liver function tests (LFTs) > 1.5x ULN
Evidence of significant organ system dysfunction (e.g. diabetes, cardiovascular disease, cirrhosis, hypogonadism, hypo- or hyperthyroidism; hypertension)
Any fluctuations in weight (no more than ± 2% of body weight) by subject self report in the 3 months prior to the Screening Visit.
Has received HPP593 in a previous clinical trial.
Smoking within 6 month prior to Day -1.
Michigan Alcohol Screening Test score greater than 2.