Clinical trial NCT01440166: Safety, Tolerability, and Pharmacokinetic Study of CAT-1004 in Healthy Adult Volunteers
Official title: A Single Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of CAT-1004 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Human healthy volunteers
Lead sponsor: Catabasis Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-09-26
Enrollment: 52
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: * To evaluate the safety and tolerability of escalating single doses of CAT-1004 relative to placebo in healthy adult volunteers.
* To evaluate the pharmacokinetics (PK) of escalating single doses of CAT-1004 in healthy adult volunteers.
* To evaluate the effect of a high-fat meal on single doses of CAT-1004 in healthy adult volunteers.


Eligibility criteria: Key Inclusion Criteria:

1. In good health.
2. Age: 19 to 55 years inclusive at Screening.
3. Satisfies one of the following

   * Females not of childbearing potential: non-pregnant and non-lactating; surgically sterile or postmenopausal, OR
   * Males: surgically sterile, abstinent, or subject or partner is utilizing an acceptable contraceptive method during and 3 months after the last study dose.
4. BMI: 18 to 30 kg/m2 at Screening.

Key Exclusion Criteria:

1. Clinically significant abnormalities in physical examination or vital signs.
2. Clinically significant electrocardiogram (ECG) abnormalities as assessed by the investigator.
3. Clinically significant screening laboratory result as assessed by the Investigator.
4. The subject has a history of clinically significant allergies (except for untreated, asymptomatic seasonal allergies at the time of dosing), or hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
5. History or presence of malignancy with the past 5 years.
6. History of alcohol or substance abuse or eating disorder within 2 years, OR regular use of alcohol within 6 months (\>14 units of alcohol per week; 1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol).
7. Use of any investigational drug or participation in any investigational study within 30 days prior to screening. For dose levels 6 and 7 fed cohorts, subjects may participate who have taken part in the dose levels 4 and 5 fasted cohort.
8. Any significant blood loss within 60 days prior to screening, e.g. blood donation, participation in study with multiple blood draws, etc.
9. Any condition, disease, disorder or clinically relevant laboratory abnormality that, in the opinion of the Investigator, would jeopardize the subject's appropriate participation in this study or obscure the effects of treatment.
10. A suspected allergy or sensitivity to CAT-1004 or excipients based upon known allergies to excipients or compounds of a similar class.
11. Any clinically significant systemic infection within 3 weeks prior to screening.
12. Use of prescription medications within 30 days of screening.

Primary outcomes:
measure: Safety
timeFrame: Change from Baseline versus Day-1 though 72 hrs post dose and EOT/FU
Secondary outcomes:
measure: Pharmacokinetic Profile
timeFrame: Plasma blood samples through 72 hrs, urine collections through 48 hrs
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion Clinical Research Unit
state: Nebraska
Study officials:
affiliation: Celerion
name: Scott Rasmussen, MD
role: PRINCIPAL_INVESTIGATOR
References: