Safety, Tolerability, and Pharmacokinetic Study of CAT-1004 in Healthy Adult Volunteers

Catabasis Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Other: Placebo; Drug: Drug

Study type: Interventional

Funder types: Industry

Identifiers

NCT01440166

CAT-1004-101

Details and patient eligibility

About

• 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.

Enrollment: 52 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

52 participants in 9 patient groups

Cohort 1 / Dose level 1

Experimental group

Description:

Single dose orally: CAT-1004 Dose level 1 or placebo

Treatment:

Drug: Drug

Other: Placebo

Cohort 2 / Dose level 2

Experimental group

Description:

Single dose orally: CAT-1004 Dose level 2 or placebo

Treatment:

Drug: Drug

Other: Placebo

Cohort 3 /Dose level 3

Experimental group

Description:

Single dose orally: CAT-1004 Dose level 3 or placebo

Treatment:

Drug: Drug

Other: Placebo

Cohort 4/ Dose level 4

Experimental group

Description:

Single dose orally: CAT-1004 Dose level 4 or placebo

Treatment:

Drug: Drug

Other: Placebo

Cohort 5/ Dose level 5

Experimental group

Description:

Single dose orally: CAT-1004 Dose level 5 or placebo

Treatment:

Drug: Drug

Other: Placebo

Cohort 2/ Dose level 2 ( FE)

Experimental group

Description:

Single dose orally (Under fed conditions): CAT-1004 Dose level 2 or placebo

Treatment:

Drug: Drug

Other: Placebo

Cohort 3/ Dose level 3 (FE)

Experimental group

Description:

Single dose orally (Under fed conditions): CAT-1004 Dose level 3 or placebo

Treatment:

Drug: Drug

Other: Placebo

Cohort 6 / Dose level 6 (FE)

Experimental group

Description:

Single dose orally (Under fed conditions) CAT-1004 Dose level 4 or placebo Subjects may be reenrolled from Cohort 4.

Treatment:

Drug: Drug

Other: Placebo

Cohort 7 / Dose level 7 (FE)

Experimental group

Description:

Single dose orally (Under fed conditions)CAT-1004 Dose level 5 or placebo Subjects may be reenrolled from Cohort 5.

Treatment:

Drug: Drug

Other: Placebo